Collaborative Institutional Training Initiative
The CITI Program
Course and Module Catalog
U.S.-ORIENTED, ENGLISH-LANGUAGE CONTENT ONLY
Updated 11 February 2012
The CITI Program © 2000-2012
All rights reserved
Contents
Using CITI Program content ........................................................................................................................ 10
CITI Program curricula............................................................................................................................. 10
Content organization: modules, courses and course stages .................................................................. 10
Sorting affiliated learners via profiles ..................................................................................................... 11
Customized institutional information and customized content ............................................................. 11
Customized reports: automatic and on-demand.................................................................................... 11
Available languages for content ............................................................................................................. 11
Animal Care and Use (ACU) ........................................................................................................................ 12
ACU Courses ............................................................................................................................................ 12
Working with the IACUC ..................................................................................................................... 12
Working with the IACUC – Refresher .................................................................................................. 13
Essentials for IACUC Members............................................................................................................ 13
Essentials for IACUC Members – Refresher [under development] ................................................... 14
Aseptic Surgery ................................................................................................................................... 14
Post Procedure Care of Mice and Rats in Research: Reducing Pain and Distress .............................. 14
Antibody Production in Animals ......................................................................................................... 15
Wildlife Field Studies [under development] .................................................................................... 15
Animal-Specific Courses ...................................................................................................................... 16
Working with Amphibians in Research Settings ................................................................................. 16
Working with Cats in Research Settings ............................................................................................. 16
Working with Cats in Research Settings – Refresher .......................................................................... 16
Working with Dogs in Research Settings ............................................................................................ 17
Working with Ferrets in Research Settings ......................................................................................... 17
Working with Fish in Research Settings [under development] ......................................................... 17
Working with Gerbils in Research Settings ......................................................................................... 17
Working with Guinea Pigs in Research Settings.................................................................................. 18
Working with Hamsters in Research Settings ..................................................................................... 18
Working with Mice in Research Settings ............................................................................................ 18
Working with Non-Human Primates in Research Settings ................................................................. 19
Working with Rabbits in Research Settings ........................................................................................ 19
Working with Rats in Research Settings ............................................................................................. 19
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Working with Swine in Research Settings ........................................................................................... 20
Biosafety and Biosecurity (BSS) .................................................................................................................. 20
BSS Courses ............................................................................................................................................. 20
Basic Introduction to Biosafety ........................................................................................................... 20
Biosafety Officer Training – Basic/Initial ............................................................................................. 20
Initial Biosafety Training ..................................................................................................................... 21
Biosafety Retraining ............................................................................................................................ 21
Animal Biosafety ................................................................................................................................. 22
Shipping and Transport of Regulated Biological Materials ................................................................. 22
OSHA Bloodborne Pathogens ............................................................................................................. 22
Select Agents, Biosecurity and Bioterrorism....................................................................................... 22
Emergency and Incident Response to Biohazard Spills and Releases................................................. 22
NIH Recombinant DNA Guidelines ...................................................................................................... 23
Personal Protective Equipment .......................................................................................................... 23
Human Gene Transfer ......................................................................................................................... 23
Nanotechnology .................................................................................................................................. 23
Institutional Biosafety Committee Member Training ......................................................................... 23
BSS Modules............................................................................................................................................ 24
Biosafety Course Overview (BSS01) .................................................................................................... 24
Laboratory-Acquired Infections (BSS02) ............................................................................................. 24
Biohazard Risk Assessment (BSS03) .................................................................................................... 24
Medical Surveillance (BSS04) .............................................................................................................. 24
Risk Management: Work Practices (BSS05) ........................................................................................ 24
Risk Management: Personal Protective Equipment BSS06) ............................................................... 24
Risk Management: Engineering Controls (BSS07) .............................................................................. 24
Risk Management: Laboratory Design (BSS08) ................................................................................... 25
Risk Management: Emergency and Spill Response (BSS09) ............................................................... 25
OSHA Bloodborne Pathogens Standard (BSS10)................................................................................. 25
NIH Guidelines for Research Involving Recombinant DNA Molecules (BSS11) .................................. 25
Human Gene Transfer Research (BSS12) ............................................................................................ 25
Select Agents, Biosecurity and Bioterrorism (BSS13) ......................................................................... 25
Shipping Regulated Biological Materials (BSS14)................................................................................ 25
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Animal Biosafety (BSS15) .................................................................................................................... 26
Understanding Nanotechnology and its Implications (BSS16) ........................................................... 26
Export Control (EC) ..................................................................................................................................... 26
U. S. Export Control Regulations ............................................................................................................. 26
U.S. Export Control Regulations: General Overview ........................................................................... 26
Export Administration Regulations ..................................................................................................... 26
International Traffic in Arms Regulations ........................................................................................... 27
Office of Foreign Assets Control ......................................................................................................... 27
Good Clinical Practice (GCP) ....................................................................................................................... 27
GCP for Clinical Trials with Investigational Drugs and Medical Devices – U.S. FDA Focus ..................... 27
GCP Introduction................................................................................................................................. 28
Overview of New Drug Development ................................................................................................. 28
ICH Overview....................................................................................................................................... 28
ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations .................................................... 28
Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices
............................................................................................................................................................ 28
Investigator Obligations in FDA-Regulated Clinical Research ............................................................. 28
Managing Investigational Agents According to GCP Requirements ................................................... 28
Conducting Clinical Trials of Medical Devices ..................................................................................... 29
Informed Consent ............................................................................................................................... 29
Detection and Evaluation of Adverse Events ...................................................................................... 29
Reporting Serious Adverse Events ...................................................................................................... 29
Monitoring of Clinical Trials by Industry Sponsors ............................................................................. 29
Audits and Inspections in Clinical Trials .............................................................................................. 29
Completing the CITI GCP Course ......................................................................................................... 30
GCP for Clinical Trials with Investigational Drugs – ICH Focus................................................................ 30
GCP Introduction................................................................................................................................. 30
Conducting Investigator - Initiated Studies According to FDA Regulations and Good Clinical Practices
............................................................................................................................................................ 30
Investigator Obligations in FDA-Regulated Clinical Research ............................................................. 31
Managing Investigational Agents According to GCP Requirements ................................................... 31
Informed Consent in Clinical Trials of Drugs ....................................................................................... 31
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Monitoring of Clinical Trials of Drugs by Industry Sponsors ............................................................... 31
Audits and Inspections in Clinical Trials .............................................................................................. 31
Overview of New Drug Development ................................................................................................. 32
ICH Overview....................................................................................................................................... 32
ICH—Comparison Between ICH GCP E6 and U.S. FDA Regulations .................................................... 32
Detection and Evaluation of Adverse Events ...................................................................................... 32
Reporting Serious Adverse Events in Investigations of Drugs and Biologics ...................................... 32
Completing the CITI GCP Course ......................................................................................................... 32
GCP for Clinical Trials with Investigational Medical Devices .................................................................. 32
GCP Introduction................................................................................................................................. 33
Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices
............................................................................................................................................................ 33
Investigator Obligations in FDA-Regulated Clinical Research ............................................................. 33
Managing Investigational Devices According to GCP Requirements .................................................. 33
Conducting Clinical Trials of Medical Devices ..................................................................................... 33
Informed Consent in Clinical Studies of Devices ................................................................................. 34
Monitoring of Clinical Trials of Devices by Industry Sponsors ............................................................ 34
Audits and Inspections in Clinical Trials of Devices............................................................................. 34
Reporting Requirements for Device Studies ....................................................................................... 34
Completing the CITI GCP Course ......................................................................................................... 34
Human Subjects Research (HSR) ................................................................................................................. 34
Biomedical Research with Human Subjects ............................................................................................ 35
Belmont Report and Course Introduction .......................................................................................... 35
History and Ethical Principles .............................................................................................................. 35
Basic Institutional Review Board (IRB) Regulations and Review Process ........................................... 35
Informed Consent ............................................................................................................................... 36
Social and Behavioral Research (SBR) for Biomedical Researchers .................................................... 36
Records-Based Research ..................................................................................................................... 36
Genetic Research in Human Populations............................................................................................ 36
Research with Vulnerable Subjects: An Overview .............................................................................. 36
Vulnerable Subjects: Research Involving Prisoners ............................................................................ 37
Vulnerable Subjects: Research Involving Children.............................................................................. 37
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Vulnerable Subjects: Research Involving Pregnant Women, Fetuses, and Neonates ........................ 37
Avoiding Group Harms: U. S. Research Perspectives .......................................................................... 37
Avoiding Group Harms: International Research Perspectives ............................................................ 37
FDA-Regulated Research..................................................................................................................... 37
Stem Cell Research Oversight – Part 1 ................................................................................................ 37
Stem Cell Research Oversight – Part 2 ................................................................................................ 38
Unanticipated Problems and Reporting Requirements in Biomedical Research................................ 38
Biomedical Research with Human Subjects – Refresher Courses .......................................................... 38
Social, Behavioral and Educational Research with Human Subjects ...................................................... 41
Belmont Report and Course Introduction .......................................................................................... 41
History and Ethical Principles – SBR .................................................................................................... 42
Defining Research with Human Subjects – SBR .................................................................................. 42
The Regulations and The Social and Behavioral Sciences – SBR ......................................................... 42
Assessing Risks in Social and Behavioral Sciences - SBR ..................................................................... 42
Informed Consent – SBR ..................................................................................................................... 42
Privacy and Confidentiality – SBR ....................................................................................................... 43
Research with Prisoners as Subjects – SBR ......................................................................................... 43
Research with Children – SBR ............................................................................................................. 43
Research in Public Elementary and Secondary Schools – SBR ............................................................ 43
International Research – SBR .............................................................................................................. 43
Internet Research – SBR...................................................................................................................... 43
Social, Behavioral and Educational Research with Human Subjects – Refresher Courses ..................... 44
Human Subjects Research (HSR) - Additional Modules of Interest ........................................................ 44
Are You Thinking About Being In a Research Study? .......................................................................... 45
Conflicts of Interest in Research Involving Human Subjects............................................................... 45
Hot Topics ........................................................................................................................................... 45
Human Subjects Research at the VA................................................................................................... 45
I Have Agreed to Be an IRB Community Member. Now What? ........................................................ 45
International Studies ........................................................................................................................... 45
Research and HIPAA Privacy Protections ............................................................................................ 46
Students in Research........................................................................................................................... 46
The IRB Member Module – “What Every New IRB Member Needs to Know” ................................... 46
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The IRB Administrator’s Responsibilities ............................................................................................ 46
Vulnerable Subjects – Research Involving Workers/Employees......................................................... 46
Information Privacy and Security (IPS) ....................................................................................................... 47
Health Information Privacy ..................................................................................................................... 47
Basics of Health Privacy ...................................................................................................................... 47
Health Privacy Issues for Clinicians ..................................................................................................... 47
Health Privacy Issues for Fundraisers ................................................................................................. 47
Health Privacy Issues for Marketers ................................................................................................... 47
Health Privacy Issues for Researchers ................................................................................................ 48
Health Privacy Issues for Students and Instructors ............................................................................ 48
Health Information Security.................................................................................................................... 48
Basics of Information Security ............................................................................................................ 48
Picking and Protecting Passwords ...................................................................................................... 48
Protecting Your Computer .................................................................................................................. 48
Protecting Your Identity ...................................................................................................................... 48
Protecting Your Portable Devices ....................................................................................................... 49
Safer Emailing and Messaging ............................................................................................................ 49
Safer Social Networking [under development] ................................................................................. 49
Safer Web Surfing ............................................................................................................................... 49
Security for Work/Workers Off-Site ................................................................................................... 49
Responsible Conduct of Research (RCR) ..................................................................................................... 49
RCR for Biomedical Sciences ................................................................................................................... 49
Research Misconduct (Biomedical)..................................................................................................... 50
Data Management (Biomedical) ......................................................................................................... 50
Authorship (Biomedical) ..................................................................................................................... 50
Peer Review (Biomedical) ................................................................................................................... 50
Mentoring (Biomedical) ...................................................................................................................... 50
Conflicts of Interest (Biomedical)........................................................................................................ 50
Collaborative Research (Biomedical) .................................................................................................. 50
Export Controls and National Security ................................................................................................ 50
RCR for Engineering ................................................................................................................................ 51
Research Misconduct (Engineering) ................................................................................................... 51
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Whistleblowing and the Obligation to Protect the Public (Engineering) ............................................ 51
Authorship (Engineering) .................................................................................................................... 51
Peer Review (Engineering) .................................................................................................................. 51
Conflicts of Interest (Engineering) ...................................................................................................... 51
Environmental and Social Dimensions of Engineering Research ........................................................ 52
Mentoring (Engineering) ..................................................................................................................... 52
Human Subjects Research (Engineering) ............................................................................................ 52
Animal Subjects Research (Engineering)............................................................................................. 52
Data Management (Engineering) ........................................................................................................ 52
Collaborative Research (Engineering) ................................................................................................. 52
Export Controls and National Security ................................................................................................ 52
RCR for Humanities ................................................................................................................................. 53
Research Misconduct (Humanities) .................................................................................................... 53
Data Management (Humanities) ........................................................................................................ 53
Authorship (Humanities) ..................................................................................................................... 53
Peer Review (Humanities) ................................................................................................................... 53
Mentoring (Humanities) ..................................................................................................................... 53
Conflicts of Interest (Humanities) ....................................................................................................... 53
Collaborative Research (Humanities).................................................................................................. 54
RCR for Physical Sciences ........................................................................................................................ 54
Research Misconduct (PhySci) ............................................................................................................ 54
Data Management (PhySci) ................................................................................................................ 54
Authorship (PhySci) ............................................................................................................................. 54
Peer Review (PhySci) ........................................................................................................................... 54
Mentoring (PhySci).............................................................................................................................. 54
Conflicts of Interest (PhySci) ............................................................................................................... 55
Collaborative Research (PhySci).......................................................................................................... 55
Export Controls and National Security ................................................................................................ 55
RCR for Research Administration............................................................................................................ 55
Introduction to RCR (Admin)............................................................................................................... 55
Collaborative Research (Admin) ......................................................................................................... 55
Human Subjects Research (Admin) ..................................................................................................... 55
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Animal Subjects Research (Admin) ..................................................................................................... 56
Conflicts of Interest (Admin) ............................................................................................................... 56
Financial Responsibility (Admin) ......................................................................................................... 56
Mentoring (Admin) ............................................................................................................................. 56
Data Management (Admin) ................................................................................................................ 56
RCR for Social, Behavioral, and Education (SBE) Sciences ...................................................................... 56
Research Misconduct (SBE)................................................................................................................. 57
Data Management (SBE) ..................................................................................................................... 57
Authorship (SBE) ................................................................................................................................. 57
Peer Review (SBE) ............................................................................................................................... 57
Mentoring (SBE) .................................................................................................................................. 57
Conflicts of Interest (SBE) ................................................................................................................... 57
Collaborative Research (SBE) .............................................................................................................. 57
Export Controls and National Security ................................................................................................ 57
RCR Case modules................................................................................................................................... 58
Research Misconduct .......................................................................................................................... 58
Data Management .............................................................................................................................. 58
Authorship .......................................................................................................................................... 58
Peer Review ........................................................................................................................................ 59
Mentoring ........................................................................................................................................... 59
Conflicts of Interest ............................................................................................................................. 59
Collaborative Research ....................................................................................................................... 60
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Using CITI Program content
This catalog provides brief descriptions of all content currently offered by the CITI Program. For
additional information on CITI Program content, or for assistance with any aspect of use of the CITI
Program website, visit the online Support Center. Chat, email and telephone contact information for
CITI Program administrative and technical support staff are provided there.
CITI Program curricula
CITI Program course content is grouped into subject areas, generally referred to as groups or curricula.
The current curricular groups (and standard abbreviations for them) are:







Animal Care and Use (ACU)
Biosafety and Biosecurity (BSS)
Export Control (EC)
Good Clinical Practice (GCP)
Human Subjects Research (HSR)
Information Privacy and Security (IPS)
Responsible Conduct of Research (RCR)
In some cases these curricular groups are further sub-divided, to cluster content according to subject
matter, disciplinary audience or regulatory focus. For example, the HSR curriculum has content focused
on social, behavioral and educational research, as well as content oriented to biomedical research. The
RCR curriculum has content designed for persons in disciplines such as biomedicine, engineering,
humanities, physical sciences, research administration, and social, behavioral and education sciences.
Content organization: modules, courses and course stages
CITI Program content is organized into modules, which can be thought of as lessons. CITI Program
courses are composed of a set of required and optional modules, customized according to the needs of
each subscribing institution’s learner groups.
At the subscriber’s discretion, the required modules of a course may be presented to learner group
members in a fixed order, or learners may be permitted to take them in any order (known as elective
order). Optional modules can also be made available. Standard modules that the institution does not
wish to present to its learners can be hidden.
Most modules have an associated quiz, with one or more multiple choice questions. The passing score
for each quiz is determined by the subscribing institution, as is the passing score for the overall course
(i.e., the average score on all required quizzes). Once all required modules of a course have been
completed, and a minimum score achieved on the associated quizzes, the course completion report is
made available to both the learner and to a subscriber’s designated administrator(s).
For any curriculum, a subscriber may specify a series of courses, known as course stages, to be taken at
defined intervals. Typically, a basic course is constructed for the first stage, composed of basic-level
modules. One or more refresher courses may be scheduled at subscriber-defined periods thereafter.
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Learners are individually notified when a refresher course is due. (NOTE: Not all CITI curricula currently
offer refresher courses and modules.)
Sorting affiliated learners via profiles
Access to most CITI Program content requires an individually-assigned username and password. This
username and password is assigned during the user registration process. During registration a new CITI
user is asked a series of “demographic” questions, including name and contact information. These data
form the basis of the user’s global profile.
For each subscriber institution with which the user is affiliated, responses to an additional set of
customized questions allows sorting of the user into one or more learner groups defined by the
subscriber. Each user has a learner profile for each subscribing institution with which he or she is
affiliated, and a concomitant set of courses and modules that are associated with that profile.
Both the global profile and the learner profile may be updated at any time. Learners who are affiliated
with more than one institution may add new learner profiles at any time.
(NOTE: Subscribers may allow their affiliated learners to use the institution’s own assigned usernames
and password, instead of CITI Program credentials. Contact the Support Center for more information
about this single-sign-on (SSO) option.)
Customized institutional information and customized content
CITI Program subscriber institutions may provide customized contact information and course completion
instructions that are made available to their affiliated learners. This information is included on the
institutional contacts and institutional instructions pages, which are accessible to the learner from
multiple menus in the CITI Program course delivery platform. (The pages typically include contact
information for persons who manage the CITI Program subscription, determine institutional training
requirements, etc., and any non-standard instructions for completion of modules and courses.)
Subscriber institutions can also add their own institution-specific training content to the CITI Platform.
These materials are organized into one or more modules, which in turn are made part of one or more
courses as determined by learner group. NOTE: There is an additional charge for formatting and
configuration of more than one customized content module.
Customized reports: automatic and on-demand
CITI Program’s software generates and sends (via email) completion reports to selected subscriber
institution administrators and coordinators, customized at the learner group level. Designated
institutional representatives can also generate their own reports from the CITI Program’s website as
needed, and download these data as needed for further processing (e.g., into Excel).
Available languages for content
Some CITI Program content is available in languages other than English, and/or with a focus on countries
other than the United States. This catalog describes only U.S.-oriented, English-language content.
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Page 11 of 60
Animal Care and Use (ACU)
ACU Courses
CITI Program’s Animal Care and Use (ACU) curriculum is designed to meet the needs of faculty, postdocs, graduate students, technicians, and any other persons involved in the conduct of research that
uses non-human vertebrate animals.
Working with the IACUC
This course is intended for laboratory research personnel who will write animal-use protocols for review
by an IACUC or who will handle animals under such protocols. It provides basic information regarding
the U.S. regulations for protection of animal subjects used in research, teaching and testing. It describes
the sources and applicability of regulations governing animals in these uses. It describes the role,
authority and composition of the IACUC, the types of IACUC review, and the items of information
required for the review. It discusses in a general way: animal surgery, blood sample collection, antibody
production (though this is discussed specifically in the Antibody Production in Animals course), and
euthanasia. General discussions are also provided for requirements for personnel training and
experience, and occupational health and safety. Recommendations for housing rodents, exercising
dogs, enriching the environment of primates, and using human patient care areas for animals are
provided. Finally, there is a discussion of the requirements for making changes in a project involving
animals and the procedures for reporting inappropriate use of animals. Animal users who will be doing
field studies on wild animals should take the Wildlife Field Studies course (under development) instead.
Module title
Introduction to Working with the IACUC
Working with the IACUC
Federal Mandates
The Veterinary Consultation
Getting Started
Alternatives
Avoiding Unnecessary Duplication
USDA Pain/Distress Categories
Endpoint Criteria
Surgery
Antibody Production
Collecting Blood Samples
Personnel Training and Experience
Occupational Health and Safety
Using Hazardous and Toxic Agents in Animals
Housing Social Animals
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
1807
1808
1809
1810
1811
1812
1813
1814
1815
1816
1817
1818
1819
1820
1821
1822
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Housing Rodents on Wire Floors
Dog Exercise
Primate Psychological Enrichment
Prolonged Restraint
Euthanasia
Using Human Patient Care Areas for Animal Research
Using Explosive Agents in the Animal Facility
Making Changes after You Receive Approval
Reporting Misuse, Mistreatment, or Non-Compliance
Final Comments
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
1823
1824
1825
1826
1827
1828
1829
1830
1831
1832
Working with the IACUC – Refresher
This course is intended for use by personnel who have previously completed the Working with the
IACUC course, and whose institution requires a refresher. It offers reviews of many of the topics
covered in the basic course, but adds additional depth, expanding on points that are often sources of
concerns and questions by IACUCs and animal users.
Module title
Introduction to Working With the IACUC - Refresher Course
The Regulators
Responsibility
Justifying Animal Use
Consider Alternatives
Duplication
Training
Housing and Husbandry
Monitoring and Controlling Pain and Distress
Surgery
Post-procedure Monitoring and Care
Endpoints
Euthanasia
Occupational Health and Safety
Final Words
References
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Module
ID #
13780
13781
13782
13783
13784
13785
13786
13787
13788
13789
13790
13791
13792
13793
13846
13794
Essentials for IACUC Members
This course is intended for persons who are members of an IACUC. It assumes the user is already
familiar with the content of the Working with the IACUC course, and it delves more deeply into the
IACUC's responsibilities, authority, membership, and relationship to the IO. It discusses the review of
animal-use protocols and the required semi-annual program review and facilities inspection in detail.
Finally, the procedures for investigating allegations of improper animal care and use are discussed.
Module title
Introduction to Essentials for IACUC Members
Recommended
Use
Required
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Module
ID #
1833
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Responsibilities of the IACUC and IACUC Members
The Members of the IACUC
The IACUC, the CEO, and the IO
Authority of the IACUC
Conducting IACUC Business–-The Quorum
Procedures for Reviewing Protocol Forms
Outcomes of Animal Protocol Reviews
The Types of Protocol Reviews
Documenting IACUC Actions
The IACUC Semi-Annual Evaluation
Performing the Facility Inspection and the Program Review
Identifying, Documenting, and Correcting Deficiencies
Investigating Allegations of Improper Animal Care or Use
Maintaining the Public Trust
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
1834
1835
1836
1837
1838
1839
1840
1841
1842
1843
1844
1845
1846
1847
Essentials for IACUC Members – Refresher [under development]
This course is intended for use by members of an IACUC who have previously completed the Essentials
for IACUC Members course and whose institution requires a refresher. It represents a completely new
format for CITI courses. Users are presented with a small numbers of scenarios that present "real-life"
problems encountered by IACUCs. They are asked to express opinions or select alternative actions that
the IACUC or the PI could take. In many cases, both sides of contentious issues are presented. This
approach is intended to form an interesting re-encounter of issues for IACUC members.
Aseptic Surgery
This single-module course is intended primarily for personnel who will be proposing or actually
performing survival surgery in animals. U.S. federal regulations require that all survival surgery be
performed aseptically. The course discusses the facilities and equipment recommended for performing
such surgery and the training of surgical personnel. It discusses in a general way the need for and
process of sterilization, the preparation of instruments and supplies, and the preparation of the animal
and the surgeon for surgery.
Module title
Aseptic Surgery
Recommended
Use
Required
Module
ID #
12840
Post Procedure Care of Mice and Rats in Research: Reducing Pain and Distress
This course provides information on how to minimize pain and distress in mice and rats during and after
experimental procedures for personnel who work with these animals. It is assumed that the user has
already completed the Working with the IACUC course. The course provides training in the detection
and monitoring signs of pain in animals. It discusses the use of animal appearance and behavior,
physical condition, and body weight in the monitoring process. The role of body temperature and fluid
and electrolyte balance in animal welfare are discussed. Particular attention is paid to the growth of
tumors in production of pain and distress. Of course, there is a discussion of the alleviation of pain and
distress in the post-procedure animal.
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Module title
Introduction to Post-Procedure Care of Mice and Rats in Research:
Minimizing Pain and Distress
Investigator Responsibility
Minimizing Sources of Nonexperimental Variation
Systematically Monitoring for Pain and Distress
Detecting Clinical Signs of Pain and Distress
Appearance and Behavior
Physical Exam for Clinical Condition
Body Weight
Fluid and Electrolyte Balance
Body Temperature
Tumors
Alleviation of Pain and Distress
Documentation of Post-Procedure Care
Summary
References
Recommended
Use
Required
Module
ID #
1868
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
1869
1870
1871
1872
1873
1874
1875
1876
1877
1878
1879
1880
1881
1882
Antibody Production in Animals
This single-module course is intended for people who plan to make their own antibodies or have them
made by someone else in the same institution. Under these conditions, the IACUC may require more
information for its review than when antibodies are to be purchased. The course discusses the
production of polyclonal antibodies: the use of antigens and adjuvants and their ability to produce pain
and distress. I t discusses the process of immunization: its location and procedures. In addition, the
course discusses the production of monoclonal antibodies and the use of ascites collection.
Module title
Antibody Production in Animals
Recommended
Use
Required
Module
ID #
13325
Wildlife Field Studies [under development]
This course is intended for persons who will write animal-use protocols for review by an IACUC or
handle wildlife animals under such protocols, and it provides basic information regarding the U.S.
regulations for protection of wildlife animal subjects used in research, teaching and testing. It describes
the sources and applicability of regulations governing animals in these uses. It describes the role,
authority and composition of the IACUC, the types of IACUC review and the items of information
required for the review. It discusses in a general way: the types of field studies, methods of animal
capture, principles and methods of restraint, animal marking, animal transportation and housing,
maintenance of wildlife in captivity, translocation and release, animal surgery, blood sample collection,
recognition and management of pain, and euthanasia. Animal users who will be doing laboratory
studies on animals should take the Working with the IACUC course instead.
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Animal-Specific Courses
The animal specific courses are intended for use by personnel who will use a specific class of animals in a
research project. It may be that more than one course should be completed because more than one
class of animals will be used. Each of these courses addresses issues specific to a single class of animals.
These issues include taxonomy of the class, occupational health issues, and special acclimation and
quarantine requirements. Special features of the biology and genetics of the class that make it
appropriate for certain kinds of research are discussed. Also presented are special considerations in
handling, pain and distress, and pain relief along with special considerations for surgery, blood
collection, injections, supportive care and monitoring, and euthanasia.
Working with Amphibians in Research Settings
This course addresses issues in the use of amphibians in research. (See description of animal-specific
courses above.)
Module title
Introduction to Working with Amphibians in Research Settings
Taxonomy, Research Mandates and Occupational Health Issues
Alternatives Search, Housing, Source, and Acclimation and
Quarantine
Biology, Pain and Distress, Handling, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Required
Required
Module
ID #
2077
2078
2081
Required
Required
2085
2089
Working with Cats in Research Settings
This course addresses issues in the use of cats in research. (See description of animal-specific courses
above.)
Module title
Introduction to Working with Cats in Research Settings
Research Mandates and Occupational Health Issues
Alternatives Search, Humane Standards, Housing, Source, and
Acclimation and Quarantine
Detecting Pain and Distress. and Biological Features
Injections, Blood Collection, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Required
Required
Module
ID #
1883
1884
1886
Required
Required
Required
1891
1893
1895
Working with Cats in Research Settings – Refresher
This course is a refresher course that addresses issues in the use of cats in research. (See description of
animal-specific courses above.)
Module title
Introduction, Occupational Health, Humane Standards, Housing,
Recommended
Use
Required
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Module
ID #
2063
Page 16 of 60
Source, and Acclimation and Quarantine
Pain and Distress, Biology, Procedures, Pain Relief
Surgery, Supportive Care, Euthanasia, References
Required
Required
2069
2073
Working with Dogs in Research Settings
This course addresses issues in the use of dogs in research. (See description of animal-specific courses
above.)
Module title
Introduction to Working with Dogs in Research Settings
Research Mandates and Occupational Health Issues
Alternatives Search, Humane Standards, Housing, Source, and
Acclimation and Quarantine
Detecting Pain and Distress. and Biological Features
Injections, Blood Collection, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Required
Required
Module
ID #
1899
1900
1902
Required
Required
Required
1908
1910
1912
Working with Ferrets in Research Settings
This course addresses issues in the use of ferrets in research. (See description of animal-specific courses
above.)
Module title
Welcome to the course Working with Ferrets in Research Settings
Research Mandates and Occupational Health
Alternatives
Humane Standards
Housing
Acclimation and Quarantine
Detecting Pain and Distress
Biological Features
Injections and Blood Collection
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Required
Required
Module
ID #
12244
12413
12414
12415
12416
12417
12418
12419
12420
Working with Fish in Research Settings [under development]
This course addresses issues in the use of fish in research. (See description of animal-specific courses
above.)
Working with Gerbils in Research Settings
This course addresses issues in the use of gerbils in research. (See description of animal-specific courses
above.)
Module title
Introduction to Working with Gerbils in Research Settings
Taxonomy, Research Mandates and Occupational Health Issues
Recommended
Use
Required
Required
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Module
ID #
2014
2015
Page 17 of 60
Alternatives Search, Humane Standards, Housing, Acclimation and
Quarantine, and Detection of Pain and Distress
Strains, Biology, Injections and Blood Collection, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Required
2001
Required
Required
2006
2010
Working with Guinea Pigs in Research Settings
This course addresses issues in the use of guinea pigs in research. (See description of animal-specific
courses above.)
Module title
Introduction to Working with Guinea Pigs in Research Settings
Taxonomy, Research Mandates and Occupational Health Issues
Alternatives Search, Humane Standards, Acclimation and
Quarantine, Housing, and Detection of Pain and Distress
Genetics, Biology, Injections and Blood Collection, Antibody
Production, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Required
Required
Module
ID #
1951
1952
1954
Required
1959
Required
1964
Working with Hamsters in Research Settings
This course addresses issues in the use of hamsters in research. (See description of animal-specific
courses above.)
Module title
Introduction to Working with Hamsters in Research Settings
Research Mandates and Occupational Health Issues
Alternatives Search, Humane Standards, Housing, Acclimation and
Quarantine, Detecting Pain and Distress
Species/Strains
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Required
Required
Module
ID #
1984
1985
1987
Required
Required
1992
1996
Working with Mice in Research Settings
This course addresses issues in the use of mice in research. (See description of animal-specific courses
above.)
Module title
Introduction to Working with Mice in Research Settings
Research Mandates and Occupational Health Issues
Alternatives Searches, Humane Standards, Housing, and
Acclimation and Quarantine
Detecting Pain and Distress, Genetics, and Biological Features
Injections, Blood Collection, and Antibody Production
Recommended
Use
Required
Required
Required
Module
ID #
1933
1934
1936
Required
Required
1940
1943
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Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Required
1946
Working with Non-Human Primates in Research Settings
This course addresses issues in the use of non-human primates in research. (See description of animalspecific courses above.)
Module title
Introduction to Working With Non-Human Primates in Research
Settings
Research Mandates and Occupational Health Issues
Alternatives Search, Humane Standards, Housing, Source, and
Acclimation and Quarantine
Detecting Pain and Distress, and Biological Features
Injections, Blood Collection, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Module
ID #
2032
Required
Required
2033
2035
Required
Required
Required
2040
2042
2044
Working with Rabbits in Research Settings
This course addresses issues in the use of rabbits in research. (See description of animal-specific courses
above.)
Module title
Introduction to Working with Rabbits in Research Settings
Research Mandates and Occupational Health Issues
Alternatives Searches, Humane Standards, Housing, and
Acclimation and Quarantine
Detecting Pain and Distress, Genetics, and Biological Features
Injections, Blood Collection, Antibody Production, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Required
Required
Module
ID #
1968
1969
1971
Required
Required
Required
1975
1977
1980
Working with Rats in Research Settings
This course addresses issues in the use of rats in research. (See description of animal-specific courses
above.)
Module title
Introduction to Working with Rats in Research Settings
Research Mandates and Occupational Health Issues
Alternatives Searches, Humane Standards, Housing, and
Acclimation and Quarantine
Detecting Pain and Distress, Genetics, and Biological Features
Injections, Blood Collection, Antibody Production, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
Recommended
Use
Required
Required
Required
Module
ID #
1916
1917
1919
Required
Required
Required
1923
1926
1929
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Reference
Working with Swine in Research Settings
This course addresses issues in the use of swine in research. (See description of animal-specific courses
above.)
Module title
Introduction to Working with Swine in Research Settings
Research Mandates and Occupational Health Issues
Alternatives Search, Humane Standards, Housing, Source, and
Acclimation and Quarantine
Detecting Pain and Distress, and Biological Features
Injections, Blood Collection, and Pain Relief
Surgery, Supportive Care and Monitoring, Euthanasia, and
References
Recommended
Use
Required
Required
Required
Module
ID #
2016
2017
2019
Required
Required
Required
2024
2026
2028
Biosafety and Biosecurity (BSS)
BSS Courses
CITI Program’s Biosafety and Biosecurity (BSS) curriculum has been designed to provide educational
modules for a wide array of biosafety and biosecurity topics. The modules address baseline information
requirements for multiple regulations, standards and guidelines. Host institutions should provide sitespecific requirements where applicable. Although the modules attempt to provide as much relevant
biosafety information for the learner as possible, the modules are in no way a replacement for the
hands on training and experience that those handling biohazards obtain from their Principal
Investigators, Laboratory Managers and/or fellow researchers.
Basic Introduction to Biosafety
This course provides an introduction to biosafety for researchers handling Risk Group 1 working only at
Biosafety Level 1 (BSL-1) containment.
Module title
Biosafety Course Overview
Risk Management: Work Practices
Recommended
Use
Required
Required
Module Alt ID
ID #
13314
BSS01
13898
BSS05
Biosafety Officer Training – Basic/Initial
This course, which includes the entire set of Biosafety and Biosecurity modules, can provide new
biosafety officers and other environmental health and safety professionals with a comprehensive
introduction to biosafety.
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Page 20 of 60
Module title
Biosafety Course Overview
Laboratory Acquired Infections
Biohazard Risk Assessment
Medical Surveillance
Risk Management: Work Practices
Risk Management: Personal Protective Equipment
Risk Management: Engineering Controls
Risk Management: Laboratory Design
Risk Management: Emergency and Spill Response
OSHA Bloodborne Pathogens Standard
NIH Guidelines for Research Involving Recombinant DNA
Molecules
Human Gene Transfer Research
Select Agents, Biosecurity and Bioterrorism (13951, 13857, 13524)
Shipping Regulated Biological Materials
Animal Biosafety
Understanding Nanotechnology and its Implications
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Module
ID #
13314
13454
13455
13456
13898
13458
13929
13484
13459
13902
13493
Alt ID
Required
Required
Required
Required
Required
13494
00000
00000
00000
00000
BSS12
BSS13
BSS14
BSS15
BSS16
BSS01
BSS02
BSS03
BSS04
BSS05
BSS06
BSS07
BSS08
BSS09
BSS10
BSS11
Initial Biosafety Training
This course provides basic training for researchers handling biohazards in a research or clinical
laboratory. This training addresses awareness of biohazards, risk assessment and key risk management
principles including work practices, personal protective equipment, engineering controls and emergency
response.
Module title
Biosafety Course Overview
Laboratory Acquired Infections
Biohazard Risk Assessment
Medical Surveillance
Risk Management: Work Practices
Risk Management: Personal Protective Equipment
Risk Management: Engineering Controls
Risk Management: Laboratory Design
Risk Management: Emergency and Spill Response
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Required
Required
Module
ID #
13314
13484
13455
13456
13898
13458
13929
13484
13459
BSS01
BSS02
BSS03
BSS04
BSS05
BSS06
BSS07
BSS08
BSS09
Biosafety Retraining
This course is a refresher for researchers handling biohazards. It is usually scheduled by the institution
periodically, to reinforce biocontainment practices to control biohazards.
Module title
Risk Management: Work Practices
Risk Management: Personal Protective Equipment
Recommended
Use
Required
Required
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Module Alt ID
ID #
13898
BSS05
13458
BSS06
Page 21 of 60
Risk Management: Engineering Controls
Risk Management: Laboratory Design
Risk Management: Emergency and Spill Response
Required
Required
Required
13459
13484
13459
BSS07
BSS08
BSS09
Animal Biosafety
This single-module course is designed for researchers and animal handlers working with small or
conventional animals used in experiments involving biohazards.
Module title
Animal Biosafety
Recommended
Use
Required
Module Alt ID
ID #
13654
BSS15
Shipping and Transport of Regulated Biological Materials
This single-module course is intended as initial training and periodic retraining for employees who
package or ship diagnostic and clinical human or animal specimens, human or animal pathogens, and
other regulated biohazards. It has been designed to meet requirements of the International Air
Transport Association and the U.S. Department of Transportation.
Module title
Shipping Regulated Biological Materials
Recommended
Use
Required
Module Alt ID
ID #
13459
BSS14
OSHA Bloodborne Pathogens
This single-module course is intended for researchers who handle human blood, tissues, body fluids, or
other potentially infectious materials. It is designed as initial training or annual retraining to meet the
requirements of the U.S. Occupational Safety and Health Administration’s Bloodborne Pathogen training
standard.
Module title
OSHA Bloodborne Pathogens Standard
Recommended
Use
Required
Module Alt ID
ID #
13902
BSS10
Select Agents, Biosecurity and Bioterrorism
This single-module course is intended for researchers who handle or have access to Select Agents,
potential biowarfare agents or other potentially dangerous biological materials. It is designed to provide
initial biosecurity awareness training, but must be augmented with site-specific biosecurity information
as required by the Select Agent regulations.
Module title
Select Agents, Biosecurity and Bioterrorism (13951, 13857, 13524)
Recommended
Use
Required
Module Alt ID
ID #
00000
BSS13
Emergency and Incident Response to Biohazard Spills and Releases
This single-module course can be used to document required biohazard training for hazardous materials
responders.
Module title
Recommended
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Module Alt ID
Page 22 of 60
Risk Management: Emergency and Spill Response
Use
Required
ID #
13459
BSS09
NIH Recombinant DNA Guidelines
This single-module course provides principal investigators and those responsible for the conduct of
recombinant DNA research experiments basic training and an overview of the requirements established
by the U.S. National Institutes of Health.
Module title
NIH Guidelines for Research Involving Recombinant DNA
Molecules
Recommended
Use
Required
Module Alt ID
ID #
13493
BSS11
Personal Protective Equipment
This single-module course may be used to satisfy U.S. Occupational Safety and Health Administration
(OSHA) personal protective equipment training requirements for researchers handling biohazards.
Module title
Risk Management: Personal Protective Equipment
Recommended
Use
Required
Module Alt ID
ID #
13458
BSS06
Human Gene Transfer
This single-module course provides training on the requirements for clinical trials involving the
introduction of recombinant DNA to human subjects. It is designed for principal investigators, clinicians,
and institutional biosafety committee members.
Module title
Human Gene Transfer Research
Recommended
Use
Required
Module Alt ID
ID #
13494
BSS12
Nanotechnology
This course provides an introduction to and general awareness of issues in nanoparticle research.
Module title
Understanding Nanotechnology and its Implications
Recommended
Use
Required
Module Alt ID
ID #
14044
BSS16
Institutional Biosafety Committee Member Training
This course provides training for members of the organization’s Institutional Biosafety Committee (IBC)
in general biosafety and the requirements of the NIH Guidelines for Research Involving Recombinant
DNA Molecules.
Module title
Biosafety Course Overview
Laboratory Acquired Infections
Biohazard Risk Assessment
Recommended
Use
Required
Required
Required
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Module
ID #
13314
13454
13455
Alt ID
BSS01
BSS02
BSS03
Page 23 of 60
Medical Surveillance
NIH Guidelines for Research Involving Recombinant DNA
Molecules
Human Gene Transfer Research
Required
Required
13456
13493
BSS04
BSS11
Required
13494
BSS12
BSS Modules
Biosafety Course Overview (BSS01)
This module serves as an introduction to both the overall course and as Biosafety training for
researchers handling Risk Group 1 agents or working only at Biosafety Level 1 containment. It has been
designed as initial training, but can also be used to retrain this population as needed on a schedule
selected by the host institution.
Laboratory-Acquired Infections (BSS02)
This module sets the foundation for the importance of biosafety by briefly reviewing seminal laboratory
acquired infections that have occurred in the research and clinical laboratory settings. Additional
supplemental cases can be explored by the student for further study and increased awareness of how
the breakdown of good microbiological practices can lead to infections and in rare cases death.
Biohazard Risk Assessment (BSS03)
This module outlines the steps involved in identifying risk factors for experiments or procedures
involving biohazards. The three P’s of Risk Assessment (Pathogen, Procedures, and Personnel) are
reviewed in depth to provide a basic foundation in this important building block of biosafety.
Medical Surveillance (BSS04)
This module reviews basic medical surveillance and occupational health program recommendations for
laboratory or clinical researchers handling biohazards.
Risk Management: Work Practices (BSS05)
Initial training targeted for researchers handling or who will handle biohazards in a research or clinical
laboratory. This training addresses an awareness of biohazards, risk assessment, and key risk
management principles including work practices, personal protective equipment, engineering controls,
and emergency response. This module now includes content formerly in Disinfection and Sterilization
and Work Safely with Sharp Instruments.
Risk Management: Personal Protective Equipment BSS06)
This module is part of the core biosafety training, but can be used as an independent module to
document OSHA required personal protective equipment (PPE) training requirements pertinent to
biohazards. The supplemental form at the end of the module and PPE Biohazard Training Table can be
used to document this training by each laboratory as well.
Risk Management: Engineering Controls (BSS07)
This module examines the engineering controls, devices and barriers that can be utilized to protect
researchers when handling biohazards in the laboratory. It describes the fundamental engineering
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controls utilized to handle biohazard safely and describes the concomitant work practices for their safe
use. This module now includes content formerly in Centrifuge Precautions and Safe Sharps Devices.
Risk Management: Laboratory Design (BSS08)
This module describes the safety features of laboratories designed to protect researchers at each of the
first three Biosafety Levels (Biosafety Levels 1, 2 and 3). The module provides a comprehensive
description of the safety factors associated with the design of a Biosafety Level 3 laboratory.
Risk Management: Emergency and Spill Response (BSS09)
This module provides biohazard emergency response training for employees who are designated as
hazardous materials responders and address the biohazard component of their annual training.
OSHA Bloodborne Pathogens Standard (BSS10)
This module is directed at researchers, employees and students who handle or have contact with human
blood, tissues, body fluids or other potentially infectious materials. In order to be used in an online
web format, the host institution must insert important site-specific regulatory and emergency
response contact information. It is designed as initial bloodborne pathogens training, to be provided at
start of work with these materials. This module can also be used as annual retraining as required by the
U.S. Occupational Safety and Health Administration. Retraining must be completed within 365 days of
the previous training class.
NIH Guidelines for Research Involving Recombinant DNA Molecules (BSS11)
This module has been created to provide Principal Investigators (PIs) and others responsible for the
conduct of recombinant DNA (rDNA) research experiments, and IBC members who review these
experiments, training in the requirements of the U.S. NIH Guidelines for Research Involving
Recombinant DNA Molecules. The module has been designed as initial training. It can also be used for
periodic refresher training for PIs and IBC members as required by the NIH Guidelines.
Human Gene Transfer Research (BSS12)
This module has been designed for principal investigators, clinicians, and IBC members participating in
the conduct or review of a human gene transfer clinical study. The module reviews the NIH and
Institutional Biosafety Committee requirements for Human Gene Transfer clinical trials.
Select Agents, Biosecurity and Bioterrorism (BSS13)
This module has been targeted for researchers who handle or have access to Select Agents, potential
biowarfare agents, or other potentially valuable biological materials. The module is divided into three
segments and provides initial and annual retraining options in Select Agents and Laboratory Biosecurity
as required by U.S. Select Agent regulations. Each segment must be augmented with site-specific
information from the host institution. The Bioterrorism segment can also be used for emergency
responders who deal with potential bioterrorism incidents.
Shipping Regulated Biological Materials (BSS14)
This module is aimed at those researchers and technicians who package and ship diagnostic or clinical
human and animal specimens, human and animal pathogens, and related regulated biohazards. It has
been designed as initial training and biennial (every 2 years) training as required by the International Air
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Transport Association or the triennial (every 3 years) training as required by the U.S. Department of
Transportation.
Animal Biosafety (BSS15)
This module has been designed as initial awareness training for researchers and animal handlers
working with small or conventional animals used in biohazard experiments. This module can also be
used for periodic refresher training based on the schedule outlined by the host institution. Additional
CITI Program content for persons involved in the conduct of research using animals can be found in the
Animal Care and Use curriculum.
Understanding Nanotechnology and its Implications (BSS16)
This module has been developed to provide basic awareness and understanding of nanoparticles and
the unique safety issues associated with their handling.
Export Control (EC)
CITI Program’s Export Control (EC) curriculum currently includes a single course, focused on U.S.
regulations for Export Control. A shorter treatment of the same topic is provided in the Export Controls
and National Security module included in courses in the Responsible Conduct of Research (RCR)
curriculum (see the RCR for Engineering course).
U. S. Export Control Regulations
This course is intended for persons whose research activities include use of or access to technologies
that may be subject to U.S. export control regulations. Modules discuss the regulations that emanate
from the U.S. Commerce, Defense, State and Treasury departments.
Module title
U.S. Export Control Regulations: General Overview
Export Administration Regulations
International Traffic in Arms Regulations
Office of Foreign Assets Control
Recommended
Use
Required
Elective
Elective
Elective
Module
ID #
14270
14268
14271
14272
U.S. Export Control Regulations: General Overview
This module provides an introduction to the nature, purpose and scope of the major U.S. export control
regulations. It defines key terms and concepts that recur throughout the export control regulations, and
identifies the major effects of export controls on research in institutions of higher education.
Export Administration Regulations
This module provides an overview of the U.S. Department of Commerce’s Export Administration
Regulations (EAR) and how those regulations apply to research in a university setting. It discusses
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Page 26 of 60
situations, materials and activities that may be controlled as well as major exclusions, and steps
necessary to comply.
International Traffic in Arms Regulations
This module provides an introduction to the International Traffic in Arms (ITAR) regulations of the U.S.
Department of State. It includes the regulatory basis of, scope and critical definitions in ITAR, and
guidance on identifying equipment, information and activities that may be subject to ITAR.
Office of Foreign Assets Control
This module provides an overview of the functions of the U.S. Department of the Treasury’s Office of
Foreign Assets Control (OFAC). OFAC enforces economic and trade sanctions against targeted foreign
countries, terrorists, drug traffickers, weapons proliferators and other threats to U.S. national security.
Good Clinical Practice (GCP)
CITI Program’s Good Clinical Practice (GCP) curriculum currently includes three course offerings: a U.S.
FDA-focused course, a course focused on investigational devices, and a course focused on drug and
biologic studies from a more international perspective.
GCP for Clinical Trials with Investigational Drugs and Medical Devices – U.S.
FDA Focus
This course is intended for research personnel involved in conducting drug, device, or biologic studies
and who would benefit from a U.S. FDA focused curriculum. For this GCP Course, it is strongly
recommended that all modules be included and that they be completed in the order listed.
Module title
GCP Introduction
Overview of New Drug Development
ICH Overview
ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations
Conducting Investigator-Initiated Studies According to FDA
Regulations and Good Clinical Practices
Investigator Obligations in FDA-Regulated Clinical Research
Managing Investigational Agents According to GCP Requirements
Conducting Clinical Trials of Medical Devices
Informed Consent
Detection and Evaluation of Adverse Events
Reporting Serious Adverse Events
Monitoring of Clinical Trials by Industry Sponsors
Audits and Inspections in Clinical Trials
Recommended
Use
Required
Required
Required
Required
Required
Module
ID #
1350
1351
1352
1354
1355
Required
Required
Required
Required
Required
Required
Required
Required
1356
1357
1358
1359
1360
1361
1362
1363
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Completing the CITI GCP Course
Required
1364
GCP Introduction
This module provides an overview of the GCP course along with links to the Belmont Report.
Overview of New Drug Development
This module describes the role of industry sponsors in the conduct of clinical trials under an
Investigational New Drug (IND) application in the U.S. according to FDA regulations. It provides an
overview of definitions, procedures, and timelines associated with the development of a new drug.
ICH Overview
The purpose of this module is to provide a basic understanding of the role of the International
Conference on Harmonisation (ICH) Guidelines and the impact on conducting clinical research according
to Good Clinical Practice (GCP). The purpose of ICH and the basic requirements for compliance with ICH
are described, including an overview of the ICH E6 GCP guidelines. The module concludes with a
discussion of when the ICH GCP guidelines apply and an introduction on how these differ from the FDA
regulations.
ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations
This module expands on the introduction presented in the ICH Overview module. The major differences
between ICH guidelines and U.S. FDA regulations are presented, including critical areas such as
confidentiality of medical records, signature of the person conducting the consent discussion, and
impartial witnesses for illiterate subjects. The module also covers the differences between ICH GCP E6
and FDA in terms of elements of consent.
Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical
Practices
This module discusses topics important to researchers who are also the sponsors of studies and thus are
conducting investigator-initiated studies. Topics discussed include how to determine whether an
Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) is required, the
role of the sponsor-investigator, documentation required for INDs and IDEs, and reports that must be
submitted to the FDA for active INDs/IDEs.
Investigator Obligations in FDA-Regulated Clinical Research
This module describes the commitments and obligations assumed by investigators when they conduct
clinical investigations sponsored by pharmaceutical companies under IND requirements, including the
requirements of the FDA Form 1572, Statement of Investigator. Required study records and reporting
requirements continue the discussion. An overview of the investigator's relationship with the sponsor
organization as well as the investigator's commitment to the subjects, the Institutional Review
Board/Ethics Committee (IRB/EC), and the U.S. Food and Drug Administration (FDA) are also included.
Managing Investigational Agents According to GCP Requirements
This module focuses on specific requirements associated with the management of investigational
products by investigators. This includes requirements for shipping and storage of investigational agents,
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 28 of 60
as well as recording the receipt, use, and final disposition of investigational agents. The module also
reviews what constitutes investigational products and the management requirements for their use by
study subjects.
Conducting Clinical Trials of Medical Devices
This module reviews the responsibilities of investigators conducting clinical research involving medical
devices. It includes a discussion of the difference between significant risk and non-significant risk
devices. The characteristics and marketing requirements for Class I, II, and III devices are reviewed. The
module concludes with a review of investigator and IRB responsibilities associated with clinical trials of
medical devices and a discussion of the different options associated with early access to investigational
devices in advance of FDA approval.
Informed Consent
This module discusses informed consent guidelines, the required and optional elements of informed
consent and the process for obtaining informed consent. There is also a discussion of the differences
between FDA and DHHS regulations. Some of the challenges associated with informed consent and the
concept of vulnerable subjects are also reviewed.
Detection and Evaluation of Adverse Events
This module reviews the definition of adverse events (AEs) and related clinical trial terminology. It
describes the process for identifying AEs in clinical research, the issues to consider in assessing the
severity and causality of AEs with examples to illustrate the evaluation process. The module also
contains a discussion on determining severity and causality. Reporting of AEs to the IRB completes the
module.
Reporting Serious Adverse Events
This module discusses the criteria for reporting of serious adverse events (SAEs) to regulatory agencies,
sponsors, etc. The discussion includes definitions for "serious" and "unexpected" adverse events and it
reviews the requirements for reporting of SAEs within time frames required by FDA and ICH. The
module provides categories of relatedness to the investigational agent and how they affect reporting.
Monitoring of Clinical Trials by Industry Sponsors
This module describes the obligation of industry research sponsors to monitor the progress of clinical
trials under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application in
the U.S. The types of site visits conducted by industry sponsors are described along with the basic
requirements for each type of site visit. The module describes the role of the investigative site during
interactions with industry sponsors as well as the requirements for record-keeping in studies regulated
by the U.S. FDA.
Audits and Inspections in Clinical Trials
This module provides a basic understanding of monitoring, audits, and inspections of clinical trials
conducted according to GCP standards. It describes the different entities that can inspect or audit a
clinical trial, the factors that can determine whether an investigator will be audited, what the auditors
and inspectors are looking for, and the results and consequences that can occur as a consequence of
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
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FDA inspection findings. Some FDA-regulated research may also involve federal funding, thereby
requiring oversight by the Office for Human Research Protections (OHRP). As a result, the module
includes information on OHRP compliance site visits and outcomes. The purpose of the FDA Bioresearch
Monitoring Program is discussed.
Completing the CITI GCP Course
This module wraps up and summarizes the issues presented in the preceding modules.
GCP for Clinical Trials with Investigational Drugs – ICH Focus
This course is intended for research personnel involved in conducting drug and biologic studies and who
would benefit from a more internationally focused curriculum. It should be noted, however, that when
appropriate references to FDA regulations and guidance are also included. For this GCP course, it is
strongly recommended that all modules be included and that they be completed in the order listed.
Module title
GCP Introduction
Conducting Investigator - Initiated Studies According to FDA
Regulations and Good Clinical Practices
Investigator Obligations in FDA-Regulated Clinical Research
Managing Investigational Agents According to GCP Requirements
Informed Consent in Clinical Trials of Drugs
Monitoring of Clinical Trials of Drugs by Industry Sponsors
Audits and Inspections in Clinical Trials of Drugs
Overview of New Drug Development
ICH Overview
ICH—Comparison Between ICH GCP E6 and U.S. FDA Regulations
Detection and Evaluation of Adverse Events
Reporting Serious Adverse Events in Investigations of Drugs and
Biologics
Completing the CITI GCP Course
Recommended
Use
Required
Required
Module
ID #
14613
14614
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
14615
14617
14618
14619
14620
14621
14622
14625
14623
14624
Required
14626
GCP Introduction
This module provides an overview of the GCP course along with links to the Belmont Report.
Conducting Investigator - Initiated Studies According to FDA Regulations and Good Clinical
Practices
Medical research is important and investigators strive to find novel therapies, new drugs, and
modifications or new uses for existing drugs. This module introduces the requirements that must be
met to conduct investigator-initiated trials of investigational drugs. The module provides an overview of
when an Investigational New Drug (IND) application must be filed, the information that must be
provided, and the requirements for monitoring of clinical trials. Given ICH E6 as a standard for the
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
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elements of clinical research including design, conduct, performance, monitoring, and auditing, this
module provides a discussion as to the purposes of monitoring and a summarizes its components.
Investigator Obligations in FDA-Regulated Clinical Research
When investigators participate in an industry-sponsored clinical investigation, they assume certain
professional and legal obligations. Investigators, therefore, must understand the study and regulatory
requirements to ensure the successful outcome of a clinical investigation. The module provides an
overview of investigator commitments and obligations, and it summarizes the investigator’s relationship
with the industry-sponsor. Particular attention is focused on two aspects of the sponsor’s site
assessments covered by ICH guidelines: adequate resources, and medical care of trial subjects.
Reporting and record-retention are also included, with applicable references to both FDA and ICH
requirements.
Managing Investigational Agents According to GCP Requirements
GCP standards require specific management of investigational products by principal investigators.
Definitions and information related to the requirements for the use of investigational products, as
defined by FDA and ICH, are presented as a basis for this module. ICH requirements associated with
investigator control continues the discussion. The module concludes with sections on shipping, storage,
dispensing, and final disposition of investigational agents.
Informed Consent in Clinical Trials of Drugs
This module discusses the informed consent guidelines (as reflected in both FDA regulations and ICH
guidelines), that set the required and optional elements of informed consent. The module also includes
a discussion of the documentation of consent with specific discussion on the role of legally authorized
representatives. Some of the challenges associated with informed consent and the concept of
vulnerable subjects are also covered, including issues related to subjects who cannot consent and the
exceptions to the informed consent requirements.
Monitoring of Clinical Trials of Drugs by Industry Sponsors
U.S. Federal regulations and the ICH guidelines require that sponsors of clinical research monitor the
studies of investigational drugs to ensure that they comply with standards for the protection of human
research subjects. This module describes the obligation of industry sponsors to monitor the progress of
clinical trials under an Investigational New Drug (IND) application as well as the requirements for site
record-keeping in studies that are regulated by the FDA and in adherence to ICH E6.
Audits and Inspections in Clinical Trials
This module provides basic information on monitoring, audits, and inspections of clinical trials
conducted according to standards for Good Clinical Practice (GCP). It describes the different entities
that can inspect or audit a clinical trial, the factors that can determine whether an investigator will be
audited, what the auditors and inspectors are looking for, and the results and consequences that can
occur as a result of FDA inspection findings. Regulatory documents reviewed during inspections are
presented and referenced to FDA and ICH GCP requirements.
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Overview of New Drug Development
This module describes the role of industry sponsors in the conduct of clinical trials under an
Investigational New Drug (IND) application in the U.S. according to FDA regulations. It provides an
overview of definitions, procedures, and timelines involved for the development of a new drug.
ICH Overview
The purpose of this module is to provide an overview of the role of the International Conference on
Harmonisation (ICH) Guidelines and their impact on conducting human clinical research. The purpose of
and the basic requirements for compliance with ICH are described, including an overview of the ICH E6
GCP guidelines. The module concludes with a discussion on when the ICH GCP guidelines apply and an
introduction on how these differ from the FDA regulations.
ICH—Comparison Between ICH GCP E6 and U.S. FDA Regulations
This module expands on the introduction presented in the ICH Overview module. The major differences
between ICH guidelines and U.S. FDA regulations are presented, including a discussion of specific areas
such as confidentiality of medical records, signature of person conducting the consent discussion,
impartial witnesses for illiterate subjects, and the elements of informed consent.
Detection and Evaluation of Adverse Events
This module reviews the definition of adverse events (AEs) and related clinical trial terminology in
accordance with ICH guidelines. It describes the process for identifying AEs in clinical research and
identifies the factors to consider in assessing the severity and causality of AEs. Examples are provided to
illustrate the evaluation process. The module also includes discussion on determining AE severity and
causality, and reporting of AEs to IRBs.
Reporting Serious Adverse Events in Investigations of Drugs and Biologics
This module discusses the criteria for reporting serious adverse events (SAEs) to regulatory agencies,
sponsors, etc. The discussion, framed by both FDA regulations and ICH guidelines, includes definitions
for "serious" and "unexpected" adverse events, and the time frames for reporting of SAEs. The module
provides categories of relatedness to the investigational agent and how they affect reporting.
Completing the CITI GCP Course
This module wraps up and summarizes the issues presented in the preceding modules.
GCP for Clinical Trials with Investigational Medical Devices
This course is intended for research personnel involved in conducting device studies. It should be noted
that, where appropriate, reference to FDA regulations and guidance is also included. For this GCP
course, it is strongly recommended that all modules be included and that they be completed in the
order listed.
Module title
GCP Introduction
Recommended
Use
Required
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
14633
Page 32 of 60
Conducting Investigator-Initiated Studies According to FDA
Regulations and Good Clinical Practices
Investigator Obligations in FDA-Regulated Clinical Research
Managing Investigational Devices According to GCP Requirements
Conducting Clinical Trials of Medical Devices
Informed Consent in Clinical Studies of Devices
Monitoring of Clinical Trials by Industry Sponsors
Audits and Inspections in Clinical Trials of Devices
Reporting Requirements for Device Studies
Completing the CITI GCP Course
Required
14634
Required
Required
Required
Required
Required
Required
Required
Required
14635
14636
14637
14638
14639
14640
14641
14642
GCP Introduction
This module provides an overview of the GCP course along with links to the Belmont Report.
Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices
This module discusses topics relevant to researchers who are also the sponsors of studies, i.e.,
investigator-initiated device studies. Topics discussed include significant risk (SR) and non-significant
risk (NSR) device studies, sponsor-investigator Investigational Device Exemptions (IDEs), and reporting
requirements.
Investigator Obligations in FDA-Regulated Clinical Research
Investigators assume responsibilities when participating in clinical investigations sponsored by device
companies under IDE requirements. This module describes the commitments and obligations assumed
by investigators. Required study records and reporting requirements continue the discussion. An
overview of the investigator's relationship with the sponsor organization as well as the investigator's
commitment to the subjects, the Institutional Review Board/Ethics Committee (IRB/EC), and the U.S.
FDA is also included.
Managing Investigational Devices According to GCP Requirements
This module focuses on specific requirements associated with the management of investigational
products by principal investigators, with a specific focus on GCP standards. The module includes a
discussion of the regulation of studies involving investigational devices, including sponsor requirements
for selecting investigators, investigator control of devices, packaging and shipping, and storage of
devices.
Conducting Clinical Trials of Medical Devices
This module reviews the responsibilities of investigators conducting clinical research involving medical
devices. It includes a discussion of the difference between significant risk (SR) and non-significant risk
(NSR) devices. The characteristics and marketing requirements for Class I, II, and III devices are
reviewed. The module concludes with a review of investigator and IRB responsibilities associated with
clinical trials of medical devices and a discussion of the different options associated with early access to
investigational devices in advance of FDA approval.
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Informed Consent in Clinical Studies of Devices
This module discusses the informed consent guidelines, the required and optional elements of informed
consent and the process for obtaining informed consent. There is also a discussion of the differences
between FDA and DHHS regulations. Challenges associated with informed consent and the concept of
vulnerable subjects are also covered.
Monitoring of Clinical Trials of Devices by Industry Sponsors
This module describes the obligation of industry research sponsors to monitor the progress of clinical
trials under an Investigational Device Exemption (IDE) in the U.S. The types of site visits conducted by
industry sponsors are described along with the basic requirements for each type of site visit. The role of
the investigative site during interactions with industry sponsors as well as the required documentation
and a review of record keeping in studies regulated by the U.S. FDA are also covered.
Audits and Inspections in Clinical Trials of Devices
This module provides a basic understanding of monitoring, audits, and inspections of clinical trials
conducted according to standards for good clinical practice (GCP). It describes the different entities that
can inspect or audit a clinical trial, the factors that can determine whether an investigator will be
audited, what the auditors and inspectors are looking for, and the results and consequences that can
stem from FDA inspection findings. Because some FDA-regulated research may also involve federal
funds there may also be Office for Human Research Protections (OHRP) oversight. As a result, the
module includes an overview of OHRP compliance site visits and outcomes. The purpose of the FDA
Bioresearch Monitoring Program is discussed.
Reporting Requirements for Device Studies
The use of investigational devices can pose significant risks to subjects, and the U.S. Food and Drug
Administration (FDA) requires reporting of certain events to ensure that all entities are adequately
informed when new risks appear. This module explains the reporting requirements of 21 CFR 812, the
FDA regulations for the conduct of investigational device studies.
Completing the CITI GCP Course
This module wraps up and summarizes the issues presented in the preceding modules.
Human Subjects Research (HSR)
CITI Program’s Human Subjects Research (HSR) curriculum is divided into materials with a focus on
biomedical research and those with a focus on social and behavioral research. Both the biomedical and
social-behavioral series include both basic and refresher courses.
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Biomedical Research with Human Subjects
This basic course provides an introduction to the elements of biomedical research, focusing on
protection of human subjects. It provides historic and current information on regulatory and ethical
issues important to the conduct of research involving human subjects.
Module title
Recommended
Use
Belmont Report and Course Introduction
History and Ethical Principles
Informed Consent
Social and Behavioral Research for Biomedical Researchers
Records-Based Research
Genetic Research in Human Populations
Research With Vulnerable Subjects: An Overview
Vulnerable Subjects: Research Involving Prisoners
Vulnerable Subjects: Research Involving Children
Basic Institutional Review Board (IRB) Regulations and Review
Process
Vulnerable Subjects: Research Involving Pregnant Women,
Fetuses, and Neonates
Avoiding Group Harm: U.S. Research Perspectives
Avoiding Group Harm: International Research Perspectives
FDA-Regulated Research
Stem Cell Research Oversight – Part 1
Stem Cell Research Oversight – Part 2
Unanticipated Problems and Reporting Requirements in
Biomedical Research
Module
ID #
1127
498
3
4
5
6
7
8
9
2
10
14080
14081
12
13882
14584
14777
Belmont Report and Course Introduction
This module provides a link to the Belmont Report. It also provides some additional information
regarding the CITI website and the availability of the Belmont Report in English, Chinese, Spanish, and
French.
History and Ethical Principles
This module discusses ethical principles for the conduct of research involving human subjects. It
provides an overview of the historical events that influenced the development of the current regulatory
requirements. A review of the Belmont Principles is also provided. The module concludes with a
discussion of the contemporary ethical standards that guide research today.
Basic Institutional Review Board (IRB) Regulations and Review Process
IRBs are a standard within the area of human subjects research. This module provides basic information
about the human subject protection regulations and IRBs, including the role, authority, and composition
of the IRB. The information presented is based on the Common Rule as codified by the U.S. Department
of Health and Human Services (DHHS) at 45 CFR 46. The different types of IRB review processes are
discussed, providing the learner with an overview of the essential issues associated with exempt,
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 35 of 60
expedited, and full (convened) IRB reviews. The module concludes with a discussion of the other
regulations and requirements (such as the U.S. Food and Drug Administration [FDA] and the
International Conference on Harmonisation [ICH]) and regulatory groups (for example, the National
Institutes of Health [NIH] and the Department of Education [DOE]) that require compliance based on
certain types of research.
Informed Consent
A fundamental tenet of human subjects research, the process and documentation of informed consent
are important concepts for researchers to understand. To that end, this module provides the learner
with the framework for informed consent found within the Common Rule. Some of the special
challenges associated with informed consent are also discussed, including informed consent as it relates
to vulnerable populations. The module concludes with a review of the requirements for waiver of
informed consent as well as the differences between FDA and DHHS regulations.
Social and Behavioral Research (SBR) for Biomedical Researchers
Because biomedical researchers employ a variety of SBR techniques within the framework of biomedical
research, it is important to understand the nature, risks, and benefits associated with these techniques.
This module discusses the types of studies that utilize SBR techniques, along with the kinds of data
collected. A review of some of the risks and benefits that are unique to SBR completes the course.
Records-Based Research
Researchers may make important advances in the fields of education, medicine, psychology and public
policy by using previously collected information that does not involve prospective interaction with
human subjects. Records-based research has its own risks, and researchers who propose to conduct
such research must have an understanding of those risks and how to minimize them. As a compliment
to that review, this module also provides learners with an overview of the types of review processes
required for records-based research. This overview includes the questions that must be addressed in
order to make the appropriate determinations with respect to review.
Genetic Research in Human Populations
Although continued advances in genetic research present exciting opportunities in biomedicine, they
also present some of the most difficult challenges with respect to the protection of human subjects.
This module begins with an introduction to the types and complexity of genetic research. The learner is
then provided with a review of ethical, legal, and regulatory issues associated with genetic research. A
discussion of the hot topic of stored biological samples concludes the module.
Research with Vulnerable Subjects: An Overview
The concept of vulnerable subjects is important to research ethics and regulatory compliance. The
foundation for this module is provided by an overview of DHHS and FDA regulations as well as ICH
guidelines. This module provides learners with an overview of the issues related to diminished
autonomy, and the need for additional protections. An overview of different classes of vulnerable
subjects concludes the module.
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Page 36 of 60
Vulnerable Subjects: Research Involving Prisoners
This module describes the special requirements for conducting research with prisoners. The learner is
provided with a review of why incarcerated individuals need special protection, as well as the regulatory
definition of what constitutes a prisoner. The module also includes a discussion of each of the
permitted categories for research involving prisoners and the required IRB considerations and
determinations. The module concludes with the topic of what happens if an enrolled subject becomes a
prisoner.
Vulnerable Subjects: Research Involving Children
This module describes the major historical events that influenced how research with children can be
conducted. It describes problems with this type of research that may violate ethical standards, the
assent and informed consent requirements, and the current efforts by the FDA to ensure the inclusion
of children in studies on the safety and efficacy of new drugs. An overview of the categories of research
involving children is provided, including examples.
Vulnerable Subjects: Research Involving Pregnant Women, Fetuses, and Neonates
This module describes the historical exclusion of women of child-bearing potential and the special
requirements for conducting research involving pregnant women and fetuses. It includes a discussion of
each of the permitted categories for research involving the pregnant women, fetuses, and neonates and
IRB review requirements and determinations. Informed consent requirements associated with the
different categories of research permitted with fetuses are also discussed.
Avoiding Group Harms: U. S. Research Perspectives
See next module description below.
Avoiding Group Harms: International Research Perspectives
These Group Harms modules describe some distinct groups or communities of people who are
vulnerable. In addition, learners are provided examples of research that have caused group harms. The
module concludes with strategies that researchers can take to reduce the risk of group harms. The
material is customized for International Research Perspectives and U.S. Research Perspectives.
Institutions can choose to assign either of the versions depending upon the institution’s research
activities.
FDA-Regulated Research
This module addresses FDA-regulated clinical research and the responsibilities of investigators, IRBs, and
sponsors when an FDA-regulated product is utilized in a study. In particular, the module includes
information on when an Investigational New Drug (IND) application is necessary and the requirements
of the FDA Form 1572. A sub-module discusses the International Conference on Harmonisation (ICH)
guidelines.
Stem Cell Research Oversight – Part 1
This module is the first of a pair of modules on human stem cells and introduces the learner to the
nature and characteristics both adult and embryonic stem cells. Learners are provided a review of the
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 37 of 60
requirements of the federal regulations associated with stem cell research and the role of both state
and local requirements.
Stem Cell Research Oversight – Part 2
This module builds on the content presented in Part 1 and provides a framework for institutional review
of stem cell research, national guidelines as well as current federal law and policy. This module provides
an overview of the National Academy of Sciences (NAS), International Society for Stem Cell Research
(ISSCR), and the NIH guidelines related to human stem cell research and research involving human
subjects. Consideration is given to DHHS and FDA regulatory requirements, Stem Cell Research
Oversight (SCRO) committee composition and responsibilities, categories of research, and a
comprehensive definition of provenance as it applies to human stem cell research. A detailed overview
of the recommendations of the NAS, ISSCR and NIH Guidelines as well as information related to the
procurement, banking, and use of human stem cell lines are provided via the hyperlinks that follow the
module.
Unanticipated Problems and Reporting Requirements in Biomedical Research
The FDA and the DHHS human subject protection regulations require institutions to have policies and
procedures to ensure prompt reporting of unanticipated problems (UPs) involving risk to subjects or
others to the IRB, regulatory agencies, and appropriate institutional officials. In addition, FDA
regulations require investigators to promptly report to the IRB all UPs involving risk to subjects or others
and unanticipated adverse device effects. The purpose of this module is to provide guidance to
investigators on complying with DHHS and FDA reporting requirements by providing an overview of UPs,
unanticipated adverse device effects, and the relationship between adverse events and UPs involving
risk to subjects or others. As a part of the discussion, the module includes a discussion on how to detect
UPs and how to report them.
Biomedical Research with Human Subjects – Refresher Courses
See below for a listing of the refresher modules available by refresher series.
Module title
Recommended
Use
Refresher Course 101 Introduction (ID: 960)
Biomedical 101 Refresher Course - History and Ethics (ID: 975)
Biomedical 101 Refresher Course - Regulations and Process (ID:
981)
Biomedical 101 Refresher Course - Informed Consent (ID: 980)
Biomedical 101 Refresher Course - Social and Behavioral Research
(ID: 982)
Biomedical 101 Refresher Course - Records Based Research (ID:
983)
Biomedical 101 Refresher Course - Genetics Research (ID: 984)
Biomedical 101 Refresher Course - Research Involving Vulnerable
Subjects (ID: 985)
Biomedical 101 Refresher Course - Vulnerable Subjects – Research
Involving Prisoners (ID: 973)
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
960
975
981
980
982
983
984
985
973
Page 38 of 60
Biomedical 101 Refresher Course - Vulnerable Subjects – Research
Involving Children (ID: 974)
Biomedical 101 Refresher Course – Vulnerable Subjects – Research
Involving Pregnant Women, Human Fetuses, and Neonates (ID:
986)
Biomedical 101 Refresher Course - FDA Regulated Research and
Conference on Harmonization (ID: 987)
Biomedical 101 Refresher Course - Conducting human subjects
Research at the VA (ID: 988)
Biomedical 101 Refresher Course - Complete the course (ID: 990)
Module title
974
986
987
988
990
Recommended
Use
Biomedical 200 Refresher Course – Introduction (ID: 764)
Biomedical 200 Refresher Course – History and Ethical Principles
(ID: 511)
Biomedical 200 Refresher Course – Regulations and Process, Part 1
(ID: 512)
Biomedical 200 Refresher Course – Regulations and Process, Part 2
(ID: 513)
Biomedical 200 Refresher Course – Informed Consent (ID: 514)
Biomedical 200 Refresher Course – Social & Behavioral Research
(SBR) (ID: 515)
Biomedical 200 Refresher Course – Genetics Research, Part 1 (ID:
518)
Biomedical 200 Refresher Course – Genetics Research, Part 2 (ID:
672)
Biomedical 200 Refresher Course – Records-Based Research, Part
1 (ID: 516)
Biomedical 200 Refresher Course – Records-Based Research, Part
2 (ID: 670)
Biomedical 200 Refresher Course – Records-Based Research, Part
3 (ID: 671)
Biomedical 200 Refresher Course – Research Involving Vulnerable
Subjects (ID: 519)
Biomedical 200 Refresher Course – Vulnerable Subjects – Research
Involving Prisoners, Part 1 (ID: 520)
Biomedical 200 Refresher Course – Vulnerable Subjects – Research
Involving Prisoners, Part 2 (ID: 549)
Biomedical 200 Refresher Course – Vulnerable Subjects – Research
Involving Children, Part 1 (ID: 521)
Biomedical 200 Refresher Course – Vulnerable Subjects – Research
Involving Children, Part 2 (ID: 550)
Biomedical 200 Refresher Course – Vulnerable Subjects – Research
Involving Children, Part 3 (ID: 551)
Biomedical 200 Refresher Course – Vulnerable Subjects – Research
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
764
511
512
513
514
515
518
672
516
670
671
519
520
549
521
550
551
522
Page 39 of 60
Involving Pregnant Women, Human Fetuses, and Neonates, Part 1
(ID: 522)
Biomedical 200 Refresher Course – Vulnerable Subjects – Research
Involving Pregnant Women, Human Fetuses, and Neonates, Part 2
(ID: 552)
Biomedical 200 Refresher Course – FDA Regulated Research, Part 1
(ID: 524)
Biomedical 200 Refresher Course – FDA Regulated Research, Part 2
(ID: 553)
Biomedical 200 Refresher Course – Human Subjects Protections at
the VA, Part 1 (ID: 525)
Biomedical 200 Refresher Course – Human Subjects Protections at
the VA, Part 2 (ID: 554)
Biomedical 200 Refresher Course – HIPAA and Human Subjects
Research (ID: 526)
Biomedical 200 Refresher Course – Conflicts of Interest in
Research Involving Human Subjects (ID: 681)
Biomedical 200 Refresher Course – How to Complete The CITI
Refresher Course and Receive the Completion Report (ID: 922)
Module title
552
524
553
525
554
526
681
922
Recommended
Use
Biomedical 201 Refresher Course - Introduction
Biomedical 201 Refresher Course - History and Ethics (ID: 993)
Biomedical 201 Refresher - Introduction and Directions (ID: 12631)
Biomedical 201 Refresher Course - Regulations and Process - The
IRB Authority and Composition (ID: 12644)
Biomedical 201 Refresher Course - Regulations and Process - The
IRB Responsibilities (ID: 12645)
Biomedical 201 Refresher Course - Regulations and Process Review for Exemption (ID: 994)
Biomedical 201 Refresher Course - Regulations and Process Continuing Review (ID: 12646)
Biomedical 201 Refresher Course - History and Ethics - Belmont
Principles, Respect for Persons (ID: 12640)
Biomedical 201 Refresher Course - History and Ethics - Belmont
Principles, Beneficence (ID: 12641)
Biomedical 201 Refresher Course - History and Ethics - Belmont
Principles, Justice (ID: 12642)
Biomedical 201 Refresher Course - Informed Consent, The
Elements of Informed Consent (ID: 1003)
Biomedical 201 Refresher Course - Informed Consent, The
Informed Consent Document (ID: 12639)
Biomedical 201 Refresher Course - Informed Consent, Risk vs.
Benefit (ID: 12634)
Biomedical 201 Refresher Course - Informed Consent, Waiving
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
993
12631
12644
12645
994
12646
12640
12641
12642
1003
12639
12634
12638
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Informed Consent (ID: 12638)
Biomedical 201 Refresher Course - Social & Behavioral Research Minimizing Harms (ID: 12637)
Biomedical 201 Refresher Course - Genetics Research (ID: 12633)
Biomedical 201 Refresher Course - Social and Behavioral Research
- Identifying Risks (ID: 1004)
Biomedical 201 Refresher Course – Research Involving Vulnerable
Subjects (ID: 12643)
Biomedical 201 Refresher Course – Vulnerable Subjects – Research
Involving Prisoners (ID: 12647)
Biomedical 201 Refresher Course – Vulnerable Subjects – Research
Involving Children (ID: 12648)
Biomedical 201 Refresher Course – Vulnerable Subjects – Research
Involving Pregnant Women, Human Fetuses, and Neonates (ID:
12649)
12637
12633
1004
12643
12647
12648
12649
Social, Behavioral and Educational Research with Human Subjects
This basic course provides an introduction to issues that arise in the context of social, behavioral and
educational (SBE) research involving human subjects.
Module title
Recommended
Use
Belmont Report and CITI Course Introduction (ID: 1127)
History and Ethical Principles - SBR (ID: 490)
Defining Research with Human Subjects - SBR (ID: 491)
The Regulations and The Social and Behavioral Sciences - SBR (ID:
502)
Assessing Risk in Social and Behavioral Sciences - SBR (ID: 503)
Informed Consent - SBR (ID: 504)
Privacy and Confidentiality - SBR (ID: 505)
Research with Prisoners - SBR (ID: 506)
Research with Children - SBR (ID: 507)
Research in Public Elementary and Secondary Schools - SBR (ID:
508)
International Research - SBR (ID: 509)
Internet Research - SBR (ID: 510)
Module
ID #
1127
490
491
502
503
504
505
506
507
508
509
510
Belmont Report and Course Introduction
This module provides a link to the Belmont Report. It also provides some additional information
regarding the CITI website and the availability of the Belmont Report in English, Chinese, Spanish, and
French.
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Page 41 of 60
History and Ethical Principles – SBR
This module discusses the evolution of the ethical principles in the United States that guide research
design as well as the development of the federal regulations that govern the conduct of research
relevant to researchers in the social and behavioral sciences. It reviews why ethics are necessary when
conducting research involving human subjects including major historical events that have influenced
how human subjects research is conducted. It describes problems with past studies that have violated
ethical standards or have raised ethical concerns that have contributed to the national dialog related to
the protection of human subjects. The Belmont Principles are discussed as the basis for the ethical
standards for research that guide us today.
Defining Research with Human Subjects – SBR
This module discusses an interpretation of definitions of the terms “human subject” and “research” with
an emphasis on the interpretation for human subjects research in the social and behavioral sciences.
Also included is a discussion as to the differences between private and public information and behavior,
a critical aspect of many types of social and behavioral research.
The Regulations and The Social and Behavioral Sciences – SBR
This module provides an overview of the federal regulations and their basic provisions. A close reading
of the regulations includes research methods and topics of inquiry relevant for researchers in the social
and behavioral sciences and the humanities. Methods include surveys, interviews, focus groups, oral
history, participant observation, observations of public behavior, and the analysis of existing data. This
module provides specific examples of the ways in which the federal regulations are particularly
pertinent to social and behavioral science researchers and the methodologies noted. In addition,
regulatory information pertinent to social and behavioral researchers is covered, including the criteria
for expedited and full board review and the authority of the IRB.
Assessing Risks in Social and Behavioral Sciences - SBR
This module discusses the challenges in identifying and evaluating risks associated with participation in
social and behavioral sciences research. Unlike biomedical clinical trials, risks associated with social and
behavioral science research are often elusive and less predictable. Topics include assessing risks,
balancing risks and potential benefits, minimizing and managing risks, certificates of confidentiality, and
ways to address risks in the informed consent document and process.
Informed Consent – SBR
This module discusses the process and documentation of informed consent, including informed consent
guidelines as well as the required and additional elements of informed consent as described by the
regulations. There is also a discussion of the circumstances under which an IRB may waive the
requirements for informed consent with examples of how this commonly is applied in social and
behavioral sciences research. The module also includes information related to recruitment, consent
comprehension, timing of consent, and exculpatory language, topics that are important to the overall
concept of informed consent.
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Page 42 of 60
Privacy and Confidentiality – SBR
This module defines privacy and confidentiality. It includes a discussion on protecting privacy in
research and guidelines for designing confidentiality procedures. Topics include private versus public
behavior, controlling access to private information, privacy and exempt research, privacy and research
methods, confidentiality, privacy and reporting laws, and certificates of confidentiality. The discussion
focuses on how these concepts apply to social and behavioral science research.
Research with Prisoners as Subjects – SBR
This module describes the requirements for conducting research with prisoners. Included in the
discussion is a review of the regulatory definition of a “prisoner,” the permitted categories of research
involving prisoners and IRB review considerations. Importantly, the module contains a discussion on
essential elements related to designing prisoner research, including consent issues and the assessment
of risk. The module concludes with information related to accessing prisoner populations.
Research with Children – SBR
This module describes regulations that apply to research with children. It defines “children” and
discusses examples of research that meet the criteria of exempt research and expedited review and
issues involved in obtaining and documenting parental permission and child assent. Included in the
discussion is a review of the criteria for waiver of parental permission and/or child assent.
Research in Public Elementary and Secondary Schools – SBR
This module provides an overview of the types of public school research, and the regulations that apply
to research in these settings. Individual sections discuss the Family Educational Rights and Privacy Act
(FERPA), the Protection of Pupil Rights Amendment (PPRA), and Subpart D at 45 CFR 46: Additional
Safeguards for Children. Examples of activities that may qualify for exemption are discussed. The
module concludes with a discussion of parental permission and child assent issues, as well as researchrelated harms to children and requirements for reporting observed child abuse and neglect.
International Research – SBR
Social and behavioral scientists conduct research around the globe. This module includes a discussion of
applicable regulations and guidelines and the importance of the local context. Because international
research may also include collaborating institutions, the module provides information related to
“engagement” in research. Additional topics include determining where research should be reviewed,
exempt research, and informed consent considerations.
Internet Research – SBR
The Internet, with an estimated 500 million users worldwide, has much to offer researchers, both as a
research tool and as the object of study. This module presents the problems associated with obtaining
consent on-line and explains why privacy and confidentiality may be of particular concern for Internet
research. In addition, several problems with assessing risks of harm associated are included as it may
often be difficult for investigators to assess these risks if they do not have previous experience with
Internet-based research.
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Page 43 of 60
Social, Behavioral and Educational Research with Human Subjects – Refresher
Courses
See below for a listing of the refresher modules available by refresher series.
Module title
Recommended
Use
SBR 101 REFRESHER MODULE 1 - History and Ethics (ID: 936)
SBR 101 REFRESHER MODULE 2 - Regulatory Overview (ID: 937)
SBR 101 REFRESHER MODULE 3 – Risk, Informed Consent, and
Privacy and Confidentiality (ID: 938)
SBR 101 REFRESHER MODULE 4 - Vulnerable Subjects (ID: 939)
SBR 101 REFRESHER MODULE 5 – Education, International, and
Internet Research (ID: 940)
How to Complete The CITI Refresher Course and Receive the
Completion Report (ID: 943)
Module title
Module
ID #
936
937
938
939
940
943
Recommended
Use
SBR 201 Introduction (ID: 12629)
SBR 201 Undue Influence (ID: 12620)
SBR 201 Research Activities Eligible for Exemption (ID: 12621)
SBR 201 Privacy vs Confidentiality in Social & Behavioral Research
(ID: 12622)
SBR 201 Assessing Risk in Social & Behavioral Research (ID: 12624)
SBR 201 Social and Behavioral Research With Prisoners (ID: 12627)
SBR 201 Defining Research with Human Subjects (ID: 12702)
Completing the SBR 201 Refresher Course (ID: 12630)
Module
ID #
12629
12620
12621
12622
12624
12627
12702
12630
Human Subjects Research (HSR) - Additional Modules of Interest
These optional modules may be added to courses in either HSR series – Biomedical or Social and
Behavioral.
Module title
Recommended
Use
Are You Thinking About Being in a Research Study?
Conflicts of Interest in Research Involving Human Subjects (ID:
488)
Hot Topics (ID: 487)
Human Subjects Research at the VA (ID: 13)
I Have Agreed to be an IRB Community Member. Now what? (ID:
13018)
International Studies (ID: 971)
Research and HIPAA Privacy Protections (ID: 14)
Students in Research (ID: 1321)
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
488
487
13
13018
971
14
1321
Page 44 of 60
The IRB Administrator’s Responsibilities (ID: 13813)
The IRB Member Module - "What Every New IRB Member Needs
to Know" (ID: 816)
Vulnerable Subjects - Research with Workers/Employees (ID: 483)
13813
816
483
Are You Thinking About Being In a Research Study?
This module is for individuals who are interested in volunteering to be a research subject. This module
may also be beneficial as an adjunct to the informed consent process for those who have already been
recruited to participate in a research project. The module provides the definition of what “research” is
and an overview of critical components of human subjects research. It is presented in a user-friendly
question and answer format. Items covered include information on the informed consent process and
what to expect after agreeing to participate in research. This module can be used in conjunction with
institution specific materials.
Conflicts of Interest in Research Involving Human Subjects
This module describes conflicts of interest, which are frequently debated and defined by varying
regulatory requirements. The module includes a general discussion of conflicts of interest with an
emphasis on financial conflicts of interest, and the ethical concerns that arise in human subjects
research. This is followed by a review of the current reporting and disclosure requirements for
investigators, including the 2011 PHS amendment and the FDA regulations. The role of IRBs and the
primary strategies for eliminating, reducing, and managing conflicts of interest completes the module.
Hot Topics
This optional module is designed to provide learners with current information on recent developments
in the IRB universe. It is updated annually, with previous content archived and accessible to learners.
Human Subjects Research at the VA
This module describes the requirements for protection of research subjects at VA facilities. Many
academic centers are affiliated with a VA clinic or hospital. Researchers proposing to recruit research
subjects from VA facilities must follow the VA requirements. This module also provides a review of what
makes the VA patient population unique and includes an overview of legally authorized representatives
for VA research.
I Have Agreed to Be an IRB Community Member. Now What?
This module is designed for new IRB community members, but may be useful to anyone involved with
human subjects research. It provides the basic information and tools, including an overview of
definitions and the regulations, and provides strategies for a community member to become a wellinformed IRB member. The module offers an overview of various aspects of the IRB review processes as
they relate to specific kinds of protocols.
International Studies
This module provides information for U.S. researchers and/or collaborating international research
investigators who receive funding from the U.S. federal government sources and who plan to conduct
human subject research outside the U.S. The module is focused on international research ethics, US
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 45 of 60
government and international guidelines. It includes a list of ethical review hyperlinks for countries and
regions of the world. It is intended to help researchers and their staff members identify ethical
requirements of their global research partners.
Research and HIPAA Privacy Protections
This module discusses the requirements of the Health Insurance Portability and Accountability Act
(HIPAA) and how they supplement the DHHS and FDA requirements. Situations where full HIPAA privacy
protections are required and those that can qualify for waivers, alterations or exemptions with more
limited requirements are discussed. The module also includes a discussion of the responsibilities of
investigators and institutions for meeting HIPAA privacy requirements, and for appropriate data security
protections that are necessary to protect privacy.
Students in Research
This module is designed as a "one-stop shop" for students who may be involved in a human subjects
research as an investigator and/or a subject. Degree requirements in undergraduate, masters, or
doctoral degree programs often require students to conduct or assist in research projects that include
human subjects. In addition, students may be asked or be "required" to participate as subjects in
research projects. A review of the history and principles of ethics for research involving human subjects,
including a definition of research and categories of review; students as researchers; the role and
operations of IRBs; and the issues related to students as subjects are provided, as well as a resource
section.
The IRB Member Module – “What Every New IRB Member Needs to Know”
This module is designed as an overview and resource for individuals joining an IRB. It includes
discussions on time commitment, liability, the role of the IRB chair, and the levels of review. An
overview of IRB tools, including the content of new submissions as well as what is often seen during
committee review provides a foundation for new IRB members and is complimented by a discussion of
how an IRB member can review protocols. The module concludes with information related to the IRB
meeting, including the importance of quorum, the types of IRB decisions, and the review of minutes.
The module is designed for new scientific and non-scientific members, but may also be useful for any
IRB member who continues to serve on an IRB.
The IRB Administrator’s Responsibilities
This module is intended for IRB administrators and directors; however, all individuals within an IRB
office might benefit from the information presented in the module. An overview of the basic policies
and procedures that institutions should have with regard to the human subjects protection program,
including the IRB, provides the foundation for the IRB administrator’s/director’s responsibilities.
Vulnerable Subjects – Research Involving Workers/Employees
This module describes why workers may be a vulnerable population when they participate in research,
and the potential risks and benefits associated with research involving workers/employees. The module
also discusses protections that need to be afforded to workers/employees. It proposes that while
workers may serve as study subjects for political as well as scientific reasons, adequacy of the science
and adherence to the Common Rule are paramount.
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 46 of 60
Information Privacy and Security (IPS)
CITI Program’s Information Privacy and Security (IPS) courses provide an overview of the elements of
data protection, focusing on requirements in the health sector.
Health Information Privacy
This course provides an overview of health information privacy issues, focusing on U.S. federal HIPAA
requirements but also addressing the requirements of states’ statutes and private certification
organizations. An initial module provides general information applicable to all members of the health
care workforce. Additional modules focus on rules applicable to particular types of work and roles
within a health care organization.
Module title
Basics of Health Privacy
Health Privacy Issues for Clinicians
Health Privacy Issues for Fundraisers
Health Privacy Issues for Marketers
Health Privacy Issues for Researchers
Health Privacy Issues for Students and Instructors
Recommended
Use
Required
Elective
Elective
Elective
Elective
Elective
Module
ID #
12652
1418
1421
1422
1419
1420
Basics of Health Privacy
This module provides general information about health privacy, applicable to all members of the
healthcare workforce. It is focused on HIPAA requirements, such as patients’ rights to notice of privacy
practices, access to and amendment of records, disclosure accounting, limits on certain kinds of
communications, and limits on certain kinds of additional uses. Concepts such as “minimum necessary,”
work-related uses and disclosures, and reasonable and appropriate practices are also discussed.
Health Privacy Issues for Clinicians
This module focuses on how HIPAA applies to persons providing treatment services. Some discussion of
state-level requirements is also provided.
Health Privacy Issues for Fundraisers
This module focuses on how HIPAA applies to persons engaged in fundraising activities. Some
discussion of state-level requirements is also provided.
Health Privacy Issues for Marketers
This module focuses on how HIPAA applies to persons engaged in marketing activities. Some discussion
of state-level requirements is also provided.
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 47 of 60
Health Privacy Issues for Researchers
This module focuses on how HIPAA applies to persons engaged in the conduct of research. Some
discussion of state-level requirements is also provided.
Health Privacy Issues for Students and Instructors
This module focuses on how HIPAA applies to persons engaged in educational activities, whether as
students or instructors. Some discussion of state-level requirements is also provided.
Health Information Security
This course provides an overview of information security practices. An initial module provides brief,
general information about security practices applicable to all health care workers. Additional modules
focus on particular types of computer activity, such as emailing and other messaging, or web surfing,
detailing safer and less safe practices.
Module title
Basics of Information Security
Picking and Protecting Passwords
Protecting Your Computer
Protecting Your Identity
Protecting Your Portable Devices
Safer Emailing and Messaging, parts 1 and 2
Recommended
Use
Required
Elective
Elective
Elective
Elective
Elective
Safer Social Networking [under development]
Safer Web Surfing
Security for Off-Site and Tele-Workers
Elective
Elective
Elective
Module
ID #
12653
1449
1425
1428
1427
1429,
1430
00000
1431
1433
Basics of Information Security
This module describes basic practices to keep information secure. It briefly discusses security of both
paper and electronic records. For the latter, brief “rules of the road” are provided for common activities
such as emailing and other messaging, web surfing, and social networking. Replaces Basics of Being
Secure, parts 1 and 2 (module IDs 1423, 1424).
Picking and Protecting Passwords
This module provides practices for safer use of the most common method of identification and
authentication.
Protecting Your Computer
This module focuses on practices to protect non-portable computers.
Protecting Your Identity
This module focuses on practices to protect one’s on-line identity, to prevent fraudulent use of that
identity by others.
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 48 of 60
Protecting Your Portable Devices
This module focuses on practices to protect portable devices, such as notebooks/laptops, tablets and
smart phones.
Safer Emailing and Messaging
This module focuses on safe practices for email and other forms of messaging such as chat, IM, and SMS
texting.
Safer Social Networking [under development]
This module focuses on safe practices for users of social networking sites and application.
Safer Web Surfing
This module focuses on safe use of websites and related applications.
Security for Work/Workers Off-Site
This module focuses on the special security needs of “tele-workers.”
Responsible Conduct of Research (RCR)
CITI Program’s Responsible Conduct of Research (RCR) curriculum currently includes six courses, each
with a disciplinary or occupational focus. The courses are targeted to biomedical, engineering,
humanities, physical sciences, and social-behavioral and education researchers; a course is also available
for research administrators.
RCR for Biomedical Sciences
This course provides an introduction to the Responsible Conduct of Research in the biomedical sciences.
The course is designed for students, faculty, postdocs and other biomedical researchers.
Module title
Research Misconduct (Biomedical)
Data Management (Biomedical)
Authorship (Biomedical)
Peer Review (Biomedical)
Mentoring (Biomedical)
Conflicts of Interest (Biomedical)
Collaborative Research (Biomedical)
Export Controls and National Security
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Elective
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
1495
1523
1518
1521
1625
1462
1484
00000
Page 49 of 60
Research Misconduct (Biomedical)
This module in the Biomedical series describes the three main practices (fabrication, falsification, and
plagiarism) that constitute research misconduct and the steps that can be taken to handle allegations of
research misconduct.
Data Management (Biomedical)
This module in the Biomedical series provides an overview of ethical issues relating to data. This
includes issues relating to data acquisition, management, sharing and ownership. The module was
formerly entitled Data Acquisition, Management, Sharing and Ownership.
Authorship (Biomedical)
This module in the Biomedical series provides an overview of the ethical responsibilities of authors. It
includes a discussion of how authorship should be determined and improper practices such as “ghost
authorship” and “gift authorship”. The module was formerly entitled Publication Practices and
Responsible Authorship.
Peer Review (Biomedical)
This module in the Biomedical series provides an overview of the ethical responsibilities of authors,
editors, and reviewers of manuscripts. It also includes a discussion of the grant proposal review process.
Mentoring (Biomedical)
This module in the Biomedical series provides an overview of the ethical responsibilities of mentors and
trainees. It includes a discussion of the differences between an advisor and a mentor and strategies for
managing conflicts between mentors and trainees. The module was formerly entitled Responsible
Mentoring.
Conflicts of Interest (Biomedical)
This module in the Biomedical series describes conflicts of interest, which are defined by varying
regulatory requirements. It includes a discussion of conflicts of interest with an emphasis on financial
conflicts of interest, the U.S. Department of Health and Human Services' (DHHS) 2011 final rule, and the
ethical concerns that arise from conflicts of commitment. The module was formerly entitled Conflicts of
Interest and Commitment.
Collaborative Research (Biomedical)
This module in the Biomedical series provides an overview of ethical issues relating to collaborative
research partnerships. It includes a discussion of issues relating to collaborating with researchers from
other disciplines and with industry.
Export Controls and National Security
This module provides an overview of U.S. export control regulations and a brief discussion of issues
researchers should be aware of relating to national security. It is written for a general audience. The
module was formerly entitled Export Control Regulations and National Security.
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Page 50 of 60
RCR for Engineering
This course provides an introduction to the Responsible Conduct of Research (RCR) in engineering. The
course is designed for students, faculty, postdocs, and other engineering researchers.
Module title
Research Misconduct (Engineering)
Whistleblowing and the Obligation to Protect the Public
(Engineering)
Authorship (Engineering)
Peer Review and Publication (Engineering)
Conflicts of Interest (Engineering)
Environmental and Social Dimensions of Engineering Research
Mentoring (Engineering)
Human Subjects Research (Engineering)
Animal Subjects Research (Engineering)
Data Management (Engineering)
Collaborative Research (Engineering)
Export Controls and National Security
Recommended
Use
Required
Elective
Module
ID #
12858
12862
Required
Required
Required
Required
Required
Required
Required
Required
Required
Elective
12877
12861
12875
12835
12863
12864
12905
12911
12912
00000
Research Misconduct (Engineering)
This module in the Engineering series describes the three main practices (fabrication, falsification, and
plagiarism) that constitute research misconduct and the steps that can be taken to handle allegations of
research misconduct.
Whistleblowing and the Obligation to Protect the Public (Engineering)
This module in the Engineering series provides a description of whistleblowing and the obligations that
engineering researchers have to protect the public. The module includes a discussion of the differences
between “internal” and “external” whistleblowing and the fundamental canon of engineering ethics.
Authorship (Engineering)
This module in the Engineering series provides an overview of the ethical responsibilities of authors. It
includes a discussion of how authorship should be determined and improper practices such as “ghost
authorship” and “gift authorship”. The module was formerly entitled Responsible Authorship in
Engineering.
Peer Review (Engineering)
This module in the Engineering series provides an overview of the ethical responsibilities of authors,
editors, and reviewers of manuscripts. It also includes a discussion of the grant proposal review process.
The module was formerly entitled Ethical Issues in Peer Review and Publication in Engineering Research.
Conflicts of Interest (Engineering)
This module in the Engineering series describes conflicts of interest, which are defined by varying
regulatory requirements. It includes a discussion of conflicts of interest with an emphasis on financial
conflicts of interest, the U.S. Department of Health and Human Services' (DHHS) 2011 final rule, and the
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 51 of 60
ethical concerns that arise from conflicts of commitment. The module was formerly entitled Conflicts of
Interest in Engineering Research.
Environmental and Social Dimensions of Engineering Research
This module in the Engineering series provides an overview of the responsibilities that engineering
researchers have to take environmental and social considerations into account. It includes a discussion
of moral development, risk, and sustainability. The module was formerly entitled Environmental Ethics.
Mentoring (Engineering)
This module in the Engineering series provides an overview of the ethical responsibilities of mentors and
trainees. It includes a discussion of the differences between an advisor and a mentor and strategies for
managing conflicts between mentors and trainees. The module was formerly entitled The Ethics of
Mentoring.
Human Subjects Research (Engineering)
This module in the Engineering series provides an introduction to ethical and regulatory issues relating
to the participation of human beings in research. It includes a description of the informed consent
process and the Common Rule, which is a set of regulations adopted by a number of U.S. federal
agencies. The module was formerly entitled Human Subjects Research in Engineering Fields. NOTE: this
module is NOT intended to replace the Human Subjects Research (HSR) course or other training required
by federal agencies or institutional review boards (IRBs).
Animal Subjects Research (Engineering)
This module in the Engineering series provides an introduction to ethical and regulatory issues relating
to the use of animal subjects in research. It includes a description of federal regulations governing how
animals subjects research should be conducted. The module was formerly entitled The Use of Live
Animals in Research. NOTE: this module is NOT intended to replace the Animal Care and Use (ACU)
course or other training required by federal agencies or institutional care and use committees (IACUCs).
Data Management (Engineering)
This module in the Engineering series provides an overview of ethical issues relating to data. This
includes issues relating to data acquisition, management, sharing and ownership. The module was
formerly entitled Data Acquisition, Management, Sharing and Ownership.
Collaborative Research (Engineering)
This module in the Engineering series provides an overview of ethical issues relating to collaborative
research partnerships. It includes a discussion of issues relating to collaborating with researchers from
other disciplines and with industry. The module was formerly entitled Collaborative Research in
Engineering Fields.
Export Controls and National Security
This module provides an overview of U.S. export control regulations and a brief discussion of issues
researchers should be aware of relating to national security. It is written for a general audience. The
module was formerly entitled Export Control Regulations and National Security.
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Page 52 of 60
RCR for Humanities
This course provides an introduction to the Responsible Conduct of Research (RCR) in the humanities.
The course is designed for students, faculty, postdocs, and other humanities researchers.
Module title
Research Misconduct (Humanities)
Data Management (Humanities)
Authorship (Humanities)
Peer Review (Humanities)
Mentoring (Humanities) (ID: 1234 or 1250?)
Conflicts of Interest (Humanities)
Collaborative Research (Humanities)
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Module
ID #
1497
1525
1533
1534
1234
1624
1058
Research Misconduct (Humanities)
This module in the Humanities series describes the three main practices (fabrication, falsification, and
plagiarism) that constitute research misconduct and the steps that can be taken to handle allegations of
research misconduct.
Data Management (Humanities)
This module in the Humanities series provides an overview of ethical issues relating to data. This
includes issues relating to data acquisition, management, sharing and ownership. The module was
formerly entitled Data Acquisition, Management, Sharing and Ownership.
Authorship (Humanities)
This module in the Humanities series provides an overview of the ethical responsibilities of authors. It
includes a discussion of how authorship should be determined and improper practices such as “ghost
authorship” and “gift authorship”. The module was formerly entitled Publication Practices and
Responsible Authorship.
Peer Review (Humanities)
This module in the Humanities series provides an overview of the ethical responsibilities of authors,
editors, and reviewers of manuscripts. It also includes a discussion of the grant proposal review process.
Mentoring (Humanities)
This module in the Humanities series provides an overview of the ethical responsibilities of mentors and
trainees. It includes a discussion of the differences between an advisor and a mentor and strategies for
managing conflicts between mentors and trainees. The module was formerly entitled Mentor and
Trainee Responsibilities.
Conflicts of Interest (Humanities)
This module in the Humanities series describes conflicts of interest, which are defined by varying
regulatory requirements. It includes a general discussion of conflicts of interest with an emphasis on
financial conflicts of interest and the ethical concerns that arise from conflicts of commitment. The
module was formerly entitled Conflicts of Interest and Commitment.
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Page 53 of 60
Collaborative Research (Humanities)
This module in the Humanities series provides an overview of ethical issues relating to collaborative
research partnerships. It includes a discussion of issues relating to collaborating with researchers from
other disciplines and with industry.
RCR for Physical Sciences
This course provides an introduction to the Responsible Conduct of Research (RCR) in the physical
sciences (“PhySci”). The course is designed for students, faculty, postdocs, and other physical science
researchers.
Module title
Research Misconduct (PhySci)
Data Management (PhySci)
Authorship (PhySci)
Peer Review (PhySci)
Mentoring (PhySci) (ID: 1234 or 1250?)
Conflicts of Interest (PhySci)
Collaborative Research (PhySci)
Export Controls and National Security
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Elective
Module
ID #
1496
1524
1527
1528
1234
1623
1514
00000
Research Misconduct (PhySci)
This module in the Physical Sciences series describes the three main practices (fabrication, falsification,
and plagiarism) that constitute research misconduct and the steps that can be taken to handle
allegations of research misconduct.
Data Management (PhySci)
This module in the Physical Sciences series provides an overview of ethical issues relating to data. This
includes issues relating to data acquisition, management, sharing and ownership. The module was
formerly entitled Data Acquisition, Management, Sharing and Ownership.
Authorship (PhySci)
This module in the Physical Sciences series provides an overview of the ethical responsibilities of
authors. It includes a discussion of how authorship should be determined and improper practices such
as “ghost authorship” and “gift authorship”. The module was formerly entitled Publication Practices and
Responsible Authorship.
Peer Review (PhySci)
This module in the Physical Sciences series provides an overview of the ethical responsibilities of
authors, editors, and reviewers of manuscripts. It also includes a discussion of the grant proposal review
process.
Mentoring (PhySci)
This module in the Physical Sciences series provides an overview of the ethical responsibilities of
mentors and trainees. It includes a discussion of the differences between an advisor and a mentor and
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
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strategies for managing conflicts between mentors and trainees. The module was formerly entitled
Mentor and Trainee Responsibilities.
Conflicts of Interest (PhySci)
This module in the Physical Sciences series describes conflicts of interest, which are defined by varying
regulatory requirements. It includes a discussion of conflicts of interest with an emphasis on financial
conflicts of interest and the ethical concerns that arise from conflicts of commitment. The module was
formerly entitled Conflicts of Interest and Commitment.
Collaborative Research (PhySci)
This module in the Physical Sciences series provides an overview of ethical issues relating to
collaborative research partnerships. It includes a discussion of issues relating to collaborating with
researchers from other disciplines and with industry.
Export Controls and National Security
This module provides an overview of U.S. export control regulations and a brief discussion of issues
researchers should be aware of relating to national security. It is written for a general audience. The
module was formerly entitled Export Control Regulations and National Security.
RCR for Research Administration
This course provides an introduction to the Responsible Conduct of Research (RCR) for research
administrators (“Admin”).
Module title
Introduction to RCR (Admin)
Collaborative Research (Admin)
Human Subjects Research (Admin)
Animal Subjects Research (Admin)
Conflicts of Interest (Admin)
Financial Responsibility (Admin)
Mentoring (Admin)
Data Management (Admin)
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
Required
Module
ID #
1712
1237
00000
00000
12827
12800
12801
12802
Introduction to RCR (Admin)
General overview of the topic.
Collaborative Research (Admin)
This module in the Administration series provides an overview of ethical issues relating to collaborative
research partnerships. It includes a discussion of issues relating to collaborating with researchers from
other disciplines and with industry.
Human Subjects Research (Admin)
This module in the Administration series provides an introduction to ethical and regulatory issues
relating to the participation of human beings in research. It includes a description of the informed
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consent process and the Common Rule, which is a set of regulations adopted by a number of U.S. federal
agencies. NOTE: this module is NOT intended to replace the Human Subjects Research (HSR) course or
other training required by federal agencies or institutional review boards (IRBs).
Animal Subjects Research (Admin)
This module in the Administration series provides an introduction to ethical and regulatory issues
relating to the use of animal subjects in research. It includes a description of federal regulations
governing how animals subjects research should be conducted. The module was formerly entitled The
Use of Live Animals in Research. NOTE: this module is NOT intended to replace the Animal Care and Use
(ACU) course or other training required by federal agencies or institutional care and use committees
(IACUCs).
Conflicts of Interest (Admin)
This module in the Administration series describes conflicts of interest, which are defined by varying
regulatory requirements. It includes a discussion of conflicts of interest with an emphasis on financial
conflicts of interest and the ethical concerns that arise from conflicts of commitment.
Financial Responsibility (Admin)
This module in the Administration series covers issues associated with the management of grant
monies. Formerly entitled Responsible Financial Management.
Mentoring (Admin)
This module in the Administration series provides an overview of the ethical responsibilities of mentors
and trainees. It includes a discussion of the differences between an advisor and a mentor and strategies
for managing conflicts between mentors and trainees. The module was formerly entitled MentorTrainee Relationships.
Data Management (Admin)
This module in the Administration series provides an overview of ethical issues relating to data. This
includes issues relating to data acquisition, management, sharing and ownership.
RCR for Social, Behavioral, and Education (SBE) Sciences
This course provides an introduction to the Responsible Conduct of Research (RCR) in the social,
behavioral, and education sciences. The course is designed for students, faculty, postdocs, and other
SBE researchers.
Module title
Research Misconduct (SBE)
Data Management (SBE)
Authorship (SBE)
Peer Review (SBE)
Mentoring (SBE)
Conflicts of Interest (SBE)
Collaborative Research (SBE)
Recommended
Use
Required
Required
Required
Required
Required
Required
Required
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Module
ID #
1495
1523
1518
1521
1625
1462
1484
Page 56 of 60
Export Controls and National Security
Elective
00000
Research Misconduct (SBE)
This module in the SBE series describes the three main practices (fabrication, falsification, and
plagiarism) that constitute research misconduct and the steps that can be taken to handle allegations of
research misconduct.
Data Management (SBE)
This module in the SBE series provides an overview of ethical issues relating to data. This includes issues
relating to data acquisition, management, sharing and ownership. The module was formerly entitled
Data Acquisition, Management, Sharing and Ownership.
Authorship (SBE)
This module in the SBE series provides an overview of the ethical responsibilities of authors. It includes
a discussion of how authorship should be determined and improper practices such as “ghost
authorship” and “gift authorship”. The module was formerly entitled Publication Practices and
Responsible Authorship.
Peer Review (SBE)
This module in the SBE series provides an overview of the ethical responsibilities of authors, editors, and
reviewers of manuscripts. It also includes a discussion of the grant proposal review process.
Mentoring (SBE)
This module in the SBE series provides an overview of the ethical responsibilities of mentors and
trainees. It includes a discussion of the differences between an advisor and a mentor and strategies for
managing conflicts between mentors and trainees. The module was formerly entitled Mentor and
Trainee Responsibilities.
Conflicts of Interest (SBE)
This module in the SBE series describes conflicts of interest, which are defined by varying regulatory
requirements. It includes a discussion of conflicts of interest with an emphasis on financial conflicts of
interest and the ethical concerns that arise from conflicts of commitment. The module was formerly
entitled Conflicts of Interest and Commitment.
Collaborative Research (SBE)
This module in the SBE series provides an overview of ethical issues relating to collaborative research
partnerships. It includes a discussion of issues relating to collaborating with researchers from other
disciplines and with industry.
Export Controls and National Security
This module provides an overview of U.S. export control regulations and a brief discussion of issues
researchers should be aware of relating to national security. It is written for a general audience. The
module was formerly entitled Export Control Regulations and National Security.
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Page 57 of 60
RCR Case modules
These case modules provide another way of reinforcing the topics of RCR. Courses may be constructed
with cases interspersed with the “topical” modules above, or with provided as entirely optional content.
Parenthetical suffixes indicate multiple disciplinary versions of the same case.
Research Misconduct
Module title
Case: Truth or Consequences (A)
Case: Truth or Consequences (B)
Case: Truth or Consequences (C)
Case: Plagiarism (A)
Case: Plagiarism (B)
Case: Plagiarism (C)
Case: Plagiarism (D)
Case: No News Is Not Good News (A)
Case: No News Is Not Good News (B)
Case: No News Is Not Good News (C)
Case: In the Field, No One Will Know (A)
Case: In the Field, No One Will Know (B)
Data Management
Module title
Case: Data Management Video Vignette
Case: Share and Share Alike (A)
Case: Share and Share Alike (B)
Case: Share and Share Alike (C)
Case: Share and Share Alike (D)
Case: Who Owns Research Data (A)
Case: Who Owns Research Data (B)
Case: The New Clinical Data Manager
Case: Links to Articles and Interesting Websites
Case: AFRI
Authorship
Module title
Case:
Case:
Case:
Case:
Case:
Case:
The Chair as an Author (A)
The Chair as an Author (B)
The Chair as an Author (C)
The Chair as an Author (D)
The Chair as an Author (A)
The Chair as an Author (B)
Recommended
Use
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Module
ID #
1470
1217
14076
1473
1472
1316
1474
1469
1494
1317
1218
1471
Recommended
Use
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Module
ID #
1211
1199
1440
1443
1442
1444
1200
1201
1202
1203
Recommended
Use
Elective
Elective
Elective
Elective
Elective
Elective
Module
ID #
1320
1378
1389
1390
1235
1379
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 58 of 60
Case: The Chair as an Author (C)
Case: The Chair as an Author (D)
Case: Taking Shortcuts
Case: The Deceased Author
Case: Irresponsible Authorship – Sherry’s Secret
Peer Review
Module title
Case:
Case:
Case:
Case:
Case:
Case:
Case:
Case:
What Is Responsible Peer Review? (A)
What Is Responsible Peer Review? (B)
What Is Responsible Peer Review? (C)
What Is Responsible Peer Review? (D)
Peer Review – Controversial Research (A)
Peer Review – Controversial Research (B)
Peer Review – Controversial Research (C)
Peer Review – Controversial Research (D)
Mentoring
Module title
Case: O, What a Tangled Web We Weave
Case: The Graduate Student Laborer
Case: Sherry’s Secret
Case: Lisa Bach’s Case
Case: The Business of Mentoring
Case: Too Much Help Is Just Too Much!
Conflicts of Interest
Module title
Case:
Case:
Case:
Case:
Case:
Case:
Case:
Case:
Case:
Case:
Case:
Case:
The Case of the Promising New Technology (A)
The Case of the Promising New Technology (B)
The Case of the Promising New Technology (C)
The Case of the Promising New Technology (D)
Janet’s Suspicions (A)
Janet’s Suspicions (B)
Janet’s Suspicions (C)
Janet’s Suspicions (D)
Cane and Abel (A)
Cane and Abel (B)
The Case of the Entrepreneurial Clinician
The Case of the Entrepreneurial Psychologist
Elective
Elective
Elective
Elective
Elective
1387
1388
1255
1256
1319
Recommended
Use
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Module
ID #
1369
1374
1382
1386
1375
1370
1383
1385
Recommended
Use
Elective
Elective
Elective
Elective
Elective
Elective
Module
ID #
1337
1338
1339
1340
1341
1342
Recommended
Use
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Module
ID #
1220
1454
1455
1456
1245
1459
1460
1461
1246
1453
1451
1457
The CITI Program Course and Module Catalog – U.S. / English-Language Only (updated 11 February 2012)
Page 59 of 60
Case: The Case of the Entrepreneurial Astronomer
Case: The Conflicted Consultant (A)
Case: The Conflicted Consultant (B)
Case: The Conflicted Consultant (C)
Case: The Conflicted Consultant (D)
Case: The Case of the Entrepreneurial Anthropologist
Case: Wally’s Easy Way Out
Collaborative Research
Module title
Case: Collaborative Research Simulation - 8 Scenarios and
resolutions
Case: When Collaborators Become Competitors (A)
Case: When Collaborators Become Competitors (B)
Case: When Collaborators Become Competitors (C)
Case: When Collaborators Become Competitors (D)
Case: When Collaborators Disagree (A)
Case: When Collaborators Disagree (B)
Case: When Collaborators Disagree (C)
Case: When Collaborators Disagree (D)
Case: Why Can't We All Just Get Along (A)
Case: Why Can't We All Just Get Along (B)
Case: Why Can't We All Just Get Along (C)
Case: Why Can't We All Just Get Along (D)
Case: Collaborations Between Academics (A)
Case: Collaborations Between Academics (B)
Case: Collaborations Between Academics (C)
Case: Marriage Has Its Advantages (A)
Case: Marriage Has Its Advantages (B)
Case: Marriage Has Its Advantages (C)
Case: Marriage Has Its Advantages (D)
Case: The Price of Collaboration
Case: A Possible Co-Author
Case: Supporting Documentation
Case: Facilitating Sharing Between Collaborators
Elective
Elective
Elective
Elective
Elective
Elective
Elective
1452
1247
1463
13774
13775
1221
1244
Recommended
Use
Elective
Module
ID #
1193
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
Elective
1182
1401
1402
1403
1391
1314
1179
1435
1396
1180
1397
1398
1394
1393
1181
1183
1404
1405
1406
1238
1239
1240
1241
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Page 60 of 60