Consortium of Academic Program in Clinical Research
Domains of Proficiency and Areas of Competency to be Utilized in the Development of Core Curricula
for Academic Programs in Clinical Research
The Consortium of Academic Programs in Clinical Research (CoAPCR) is comprised of academic institutions which offer degree
programs for current and future staff members of the clinical research enterprise. The group has developed this set of core
competencies using a modified Delphi approach that included input from current clinical research core competency publications,
CoAPCR member faculties, specialty groups and stakeholders to serve as a guide for the development and evaluation of clinical
research curricula at academic institutions offering these degrees and certifications.
DRAFT DOCUMENT: October 29, 2012
I. Scientific Concepts and Principles of Research Design
Cognitive Domain
1. Demonstrate a basic knowledge of medical
terminology, anatomy, physiology, public
health, and, pathophysiology
2. Demonstrate a general knowledge of
pharmacology
3. Demonstrate the ability to critically read and
understand the professional literature of your
field
4. Identify clinically important questions in your
field
5. Compare and contrast clinical care and clinical
research roles for healthcare professionals
6. Explain how a research question effects study
population selection, design, outcome
measures and size of study
7. Describe the sampling or randomization
process for clinical study protocols
8. Describe sources of bias in clinical research
9. Define different types of end points in clinical
studies
10. Define basic statistical terminology
11. Describe the components of a statistical
analysis plan
12. Define basic epidemiological terminology and
distinguish between odds ratio, relative risk,
Psychomotor Domain
1. Demonstrate the use of library database
software to conduct a focused literature review
on a research topic.
2. Outline the advantages and disadvantages of
observational and experimental research
designs
3. Give examples of common sources of bias tell
how they are threats to internal and external
validity
4. Calculate basic descriptive statistics for central
tendency and dispersion
5. Outline a research protocol
1
Affective Domain
1. Discuss how a researcher’s behaviors and
attitudes can be a threat to internal and external
validity of studies
2. Discuss potential conflicts between clinical and
research roles for various researcher positions
hazards ratio and attributable risk
13. Identify appropriate information sources for a
review of literature
14. Explain what is meant by evidence based
medicine
15. Explain the difference between systematic
reviews and meta-analyses
16. Critically analyze and discuss study results
17. Define comparative effectiveness research,
outcomes research and health services
research
II. Medical Product Development
Cognitive
1. Discuss the history of governmental regulation
of drug, biologics, devices and food
2. Interpret significant historical clinical research
laws and guidelines
3. Describe the roles of sponsors, partners and
stakeholders in medical product discovery
4. Define and distinguish between the different
centers and offices of the U.S. FDA: especially
CBER, CDER, CFSAN, and CDRH
5. Explain the organization and structure of the
EMA and other international regulatory
agencies
6. Describe the International Conference on
Harmonization (ICH), the process for its
development, and its impact on global clinical
research
7. Compare the clinical processes which lead to
drug and device approvals
8. Describe all four phases of drug development
9. Discuss good Laboratory Practices (GLP) and
GCP regulation for the preclinical and premarketing phases
10. Describe the IDE process
11. Identify reimbursement issues related to device
development
12. Discuss issues for combined drug, biologic and
device studies
13. Identify all pertinent regulatory authorities and
organizations which develop standards for
Psychomotor
1. Locate, explore and discuss content of
websites for FDA departments (CBER, CDER,
CFSAN, and CDRH) and ICH, EMA and other
international regulatory agencies
2. Apply regulations for a mock study using a
product that has a combination of drug, device
and biologic.
2
Affective
1. Appreciate the differences between country
regulations
2. Discuss potential conflicts in product
development in cross-national studies
drugs, biological, and devices
14. Define efficacy, safety and effectiveness
15. Explain the difference between quality control
and quality assurance
16. Describe post-marketing studies and safety
reporting systems
17. Describe pharmacovigilance planning
18. Describe the global expansion of clinical
research and the issues relating to the conduct
of global clinical trials
19. Describe the difference between prescription
drug advertising and nonprescription drug
advertising
20. Describe what orphan drugs are and discuss
appropriate uses
21. Identify typical stakeholder cycle in the drug
development process (i.e., consumers, drug
company, non-governmental organizations,
manufacturers, pharmacies, etc.)
III. Ethical Considerations and the Responsible Conduct of Clinical Research
Cognitive
1. Describe the significance of historical abuses
on the evolution on principles of human subject
protection in clinical research
2. Identify the key documents relating to the
ethical conduct of clinical trials
3. Describe strategies for fairness in recruiting
participants and distribution of benefits and
burdens in clinical research
4. Describe the mission, function and procedures
of the institutional review board/ethics
committee
5. Describe the informed consent process for
adults, children and vulnerable populations
6. Discuss requirements for privacy protection
7. Identify programs developed by the Council for
International Organizations of Medical Sciences
(CIOMS)
8. Describe responsibility of researchers in
addressing health inequities, disparities and
involvement of vulnerable populations
Psychomotor
1. Conduct an internet search to identify past and
current ethical abuses in clinical research.
2. Provide documentation of GCP and IRB
certification from CITI
3
Affective
1. Discuss the historical and cultural perspectives
which relate to human subject protection
2. Describe the ethical issues involved in the
recruitment of vulnerable research participants
3. Discuss barriers and facilitators of informed
consenting
4. Identify and discuss evolving ethical conflicts
based on issues related to genetics, internet,
community, gender, students and race/ethnicity
in research.
9.
Describe appropriate considerations for
standards of care, tissue banking, and
dissemination of research results
IV. Clinical Study Operation and Regulatory Compliance
Cognitive
1. Describe the roles and responsibilities of the
various clinical investigation participants
(investigators, institutions, government, private
sites, and pharmaceutical industry, patients,
health care consumers) as determined by
Good Clinical Practice guidelines
2. Evaluate Clinical Trial Design, conduct and
documentation required for compliance with
ICH GCP’s
3. Identify the content that must be included on
the various forms required by the FDA for IND
and NDA submissions
4. Compare and contrast the similarities and
differences between US FDA regulations, ICH
Good Clinical Practices and the European
Clinical Directive
5. Describe how study populations are specified in
a clinical research protocol
6. Compare the regulatory requirements for
protection of human subjects as described in
Titles 21 and 45 of the US Code of Federal
Regulations
7. Differentiate between regulations and
guidelines
8. Discuss the financial disclosure requirements of
investigators
9. Discuss HIPAA and its relevance to clinical
research
10. Describe the regulatory requirements and
elements of an informed consent document
11. Describe requirements for ensuring proper
collection and processing of clinical research
specimens
12. Describe IND safety reports
13. Describe drug accountability requirements
14. Distinguish between adverse events and
Psychomotor
1. Complete an FDA Form 1571 and 1572, and
assemble required documents that accompany
each.
2. Prepare a diagrammatic representation of the
organization of the ICH Common Technical
Document
3. Obtain HIPAA compliance certification from
available public or institutional online training
courses
4. Assess a study protocol for feasibility as related
to sponsor and site requirements
5. Match adverse events to MEDRA reporting
terminology
6. Develop a site response to an FDA 483 letter
and an associated SOP/training plan.
7. Screen sample patient records for inclusion in a
mock study protocol
4
Affective
1. Discuss case studies that identify privacy
issues in clinical research
serious adverse events
15. Identify the basic types of post-marketing alert
reports
16. Describe the role of the Data Safety Monitoring
Board
17. Describe MEDRA and other database systems
that can help identify safety signals
18. Differentiate between sponsor audits and
regulatory inspections
19. Evaluate a FDA warning letter, and identify
appropriate corrective action
20. Describe Phase IV marketing studies
21. Discuss the regulatory approach to developing
and registering combination products
22. Describe the FDA’s accelerated Drug
Approval/Expanded Access Programs
V. Study and Site Management
Cognitive
1. Describe sponsor requirements for
investigator/site recruitment, selection,
initiation, monitoring and termination
2. Identify the components of investigator’s
meetings
3. Describe methods for recruiting and retaining
clinical research participants
4. Describe investigator/site methods for deciding
whether or not to participate in a clinical trial
5. Describe requirements for investigator
interaction with the IRB/IEC throughout the
conduct of the study
6. Identify and explain materials required for
essential regulatory documents
7. Describe the sponsor requirements for product
packaging and management
8. Describe the requirements for product
management and accountability at the site
9. Describe requirements for vendor selection and
oversight
10. Describe site requirements to prepare for
sponsor visits (initiation, monitoring, audit,
Psychomotor
1. Develop an investigator meeting agenda
2. Develop a recruitment plan for a sample
protocol
3. Develop a study budget associated with a
sample study protocol
4. Evaluate proposals from several clinical
research vendors
5. Develop job descriptions for monitors and
project managers
6. Develop job descriptions for study coordinators
7. Describe the application of an interactive voice
response system (IVRS) as it relates to
product randomization, accountability and
ordering
8. Develop a CRA visit report and follow-up
correspondence
9. Develop a time and events schedule for study
start-up through reporting
5
Affective
1. Identify different perspectives of stakeholders in
clinical research
2. Discuss time management issues in managing
site operations
3. Discuss relationships between monitors and
site study personnel
closeout)
11. Discuss methods for monitoring participant
compliance/adherence
12. Describe the requirements of a CRA site visit
trip report and follow up letter
13. Describe the use of clinical research software
to recruit subjects and manage clinical studies
14. Describe preparations for study close-out and
long term archiving of records
15. Describe the procedure for breaking the blind
16. Describe the roles and responsibilities of
project managers in clinical research operations
VI. Data Management and Informatics
Cognitive
1. Describe the typical flow of data throughout a
clinical trial
2. Discuss various data collection and data
capture procedures
3. Describe the processes and standards for
approving and maintaining the data
management plan
4. Describe electronic data capture (EDC) and the
importance of information technology in data
collection, capture and management
5. Discuss the process for review, resolution and
tracking of data errors
6. Describe the ICH GCP requirements for data
correction and queries
7. Describe the required components of a Data
Quality Assurance Plan
8. Describe the procedures for database lock and
understanding the concept of “frozen data”
9. Describe the process for unlocking a database
10. Describe the regulatory requirements and
procedures for data archival
Psychomotor
1. Develop a diagram to describe a clinical trial
protocol and the flow of data
2. Develop and explain an example of a relational
database using excel for a small descriptive
application
3. Perform an audit and associated report of
sample case report forms and clinical data
4. Perform an audit of case report forms and
database output for secondary audit of data
5. Demonstrate basic computer aptitude and the
ability to use Microsoft Word, Excel,
PowerPoint and internet utilities.
6
Affective
1. Discuss process issues in assuring accurate
data capture in a clinical trial.
2. Explain the purpose of best practices for data
management for new study site staff
VII. Communication of Scientific Data
Cognitive
1. Discuss the relationship and appropriate
communication between the Sponsor, CRO
and the clinical research site
2. Explain the peer review process for publishing
a research paper
3. Describe the data requirements for a typical
research publication
4. Describe the advantages and disadvantages of
different ways of presenting data (listings,
tables and graphs) in a typical research
publication
Psychomotor
1. Assemble a literature review on a focused topic
2. Critique a journal article or grant proposal
3. Develop an annotated bibliography of selected
key references using a standardized citation
method and paraphrase.
4. Write an abstract
5. Develop a scientific poster using a standard
template
6. Develop a presentation on findings from a
focused literature review
7. Prepare content for a draft manuscript for peer
editing and publication using a standardized
citation method (e.g., APA formatting)
6. Develop a table and figure according to
publication requirements.
Affective
1. Discuss the writing process and issues for
novices beginning to develop scientific
communication materials such as abstracts,
posters and manuscripts.
2. Identify and discuss examples of plagiarism
3.
Psychomotor
1. Demonstrate understanding of how to
coordinate meetings involving personnel with
differing responsibilities and skill sets in the
clinical research process
2. Demonstrate an understanding of techniques
for negotiation and problem solving.
3. Participate in team-building activities in a
clinical research setting
4. Develop an ePortfolio that illustrates
knowledge, achievement, activities and
samples of work in clinical research
5. Demonstrate the ability to utilize critical thinking
skills in a professional setting
6. Evaluate a project to develop the scope of
work, provide accurate cost estimates, plan
various tasks, and allocate resources
Affective
1. Discuss the impact of cultural diversity and the
need for cultural competency in the conduct of
clinical research
2. Discuss the ethical and professional issues
(conflicts of interest, plagiarism, authorship and
intellectual property) associated with clinical
research
3. Discuss examples of scientific misconduct and
fraud
4. Develop a personal statement on professional
ethics and behavior as a clinical researcher
VIII. Professionalism, Teamwork and Leadership
Cognitive
1. Define concepts of interdisciplinary,
multidisciplinary and translational research
2. Identify the ethical and professional issues
(conflicts of interest, plagiarism, authorship and
intellectual property) associated with clinical
research
3. Discuss the impact of technology on medical
research, education and patient care
4. Identify professional codes of ethics across
disciplines (Nursing License, Medical License,
Pharmacy License)
5. Identify human resource issues in hiring and
evaluating personnel across groups (industry,
institutional)
6. Define leadership and the application of
leadership values across disciplines
7. Identify project management principles as they
relate to clinical trial project planning
7