Department of Interdisciplinary Studies
IDST 1240
Introduction To Clinical Research
Course Description
This course is designed to provide students with a basic understanding of what clinical research is and the scientific principles on
which it is based. The course starts with a historical perspective on clinical research and then goes on to explore in detail the
following topics: purpose and phases of clinical research, clinical trial development and conduct, ethical and regulatory implications,
and the roles and responsibilities of all parties involved in clinical research.
Credits/Modes of Instruction
This is a 3-credit undergraduate course in lecture format that relies on regular activities, assignments, and completion of weekly
topics.
Prerequisites
Successful completion of the following two courses: Dynamics of Health Care in Society and Medical Terminology
Instructor
The instructor will be a Rutgers SHRP faculty (or adjunct) member.
Course Goals and Objectives:
Goals
The goal of this course is to provide students with the fundamentals of clinical research focusing on its purpose, development,
regulations, and implications in healthcare.
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Objectives
After completion of this course, students will be able to:
1. Describe the purpose and functions of clinical research and how they have evolved over time.
2. Provide a basic explanation of various study designs and utilize this information to evaluate peer-reviewed, published clinical
research.
3. Discuss how ethics is relevant to clinical research and describe the ethical principles which guide clinical research.
4. Describe the regulatory and safety measures in place to protect human subjects in clinical research.
5. Identify the various organizations and personnel involved in clinical research and explain their functions and roles.
6. Explain how a clinical trial protocol is developed and implemented.
7. Discuss the critical role of data management in research and what factors drives this process.
8. Describe the processes and entities in place to ensure clinical quality control and drug safety.
Course Requirements
Requirements for Completion
Attendance is required to keep up with the information presented in class. Students will be expected to participate in classroom
discussions and group activities. Each course unit will include readings, assignments, and a short quiz. In addition, successful
completion of the four course projects will be required. There will be a cumulative final exam based on class content and assigned
readings.
Requirements
Weight
Attendance/Participation/Group Discussion
10%
Unit Quizzes
20%
Unit Assignments/Homework
10%
Course Projects
40%
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

Research Ethics Paper
Journal Club Presentation
Clinical Trial Protocol Design
2

Careers in Clinical Research Assignment
Final Examination
20%
Total
100%
Evaluation, Feedback and Grading
Evaluation/Assessment Methods
 Attendance/Participation/Group Discussion – Students are expected to attend all classes and participate in classroom
discussions and group activities.
 Unit Quizzes: Students will be required to take a short quiz at the completion of each unit. Content will be based on lectures,
readings, and classroom discussions/activities.
 Unit Assignments – Each unit will have specific assignments geared to meet unit objectives. These assignments can be
completed as homework or in class, as time permits.
 Course Projects – There will be four major projects due throughout the course. Each project will have specific directions for
completion and students are expected to work individually on these projects.
 Final Examination – Successful completion of a cumulative final exam at the end of the course is required.
Feedback on Progress
Students will receive feedback on their performance on a regular basis. Quantitative and qualitative feedback will be provided for all
assignments, quizzes/tests, and projects.
Grade Determination
The minimum level of satisfactory performance in this course is a ‘C’ or better. To receive a ‘C’ or better, students must first complete ALL
course requirements specified above, including meeting the minimum attendance expectation. Based on the evaluations methods and
criteria previously described, each requirement is then scored on a 0-100 point scale. The final letter grade is based on the weighted
average of all requirements, as specified in the table below.
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Upon successful completion of the course students will be eligible to take the Health Science Careers standardized exam to
determine college credit.
High school students must attain a C (74) or better to earn college credits.
For Introduction to Clinical Research, the Rutgers grade listed on transcript will be comprised of 75% of the Rutgers SHRP standardized
exam grade and 25% of the high school course grade.
Health Science Careers Program
Grading System
Weighted
Average of All
Requirements
Final
Letter
Grade
94-100
A
90-93
A-
87-89
B+
84-86
B
80-83
B-
77-79
C+
74-76
C
70-73
C-
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Faculty/Student Honor Code
(Refer to your SHRP Student Handbook at http://shrp.rutgers.edu/current_students/handbook.pdf)
The faculty of Rutgers School of Health Related Professions believe that students must observe and support high standards of honesty
and integrity in all aspects of education, practice, and research. For this reason, all matriculated and non-matriculated students in this
course are expected to abide by the School's Faculty/Student Honor Code and accept responsibility to help ensure that these standards
are maintained by reporting violations of the Honor Code observed in others. All violations will be considered with gravest concern
and may be punishable with sanctions as severe as suspension or dismissal.
General Learning Resources
Required Textbook(s):
Jacobsen, Kathryn H. Introduction to Health Research Methods: A Practical Guide. 2012. Jones and Bartlett Learning, 5 Wall Street,
Burlington, MA. 2012. (ISBN:13:978-0-7637-8334-1)
Nesbitt, L. Clinical Research: What It Is and How It Works. Boston, MA: Jones and Bartlett Publishers. 2004. (ISBN: 0763731366)
Highly Recommended:
J. Dennis Blessing and J. Glenn Forister. Introduction to the Research and Medical Literature for Health Professions, Third Edition
2013. Jones and Bartlett Learning, 5 Wall Street, Burlington, MA 01803 (ISBN: 978-1-4496-5033-3)
Gallin, J., Ognibene, F. Principles and Practice of Clinical Research, 2nd Edition. Boston, MA: Academic Press/Elsevier. 2007.
(ISBN: 9780123694409)
Other Required Learning Resources
Various website links will be provided in the Learning Resources section for each unit in the Course Schedule. Students are required
to access these websites for completion of assigned readings and activities.
Course Units/Schedule
Note: this schedule is a plan only, subject to change by the instructor as deemed necessary to achieve the course goals. Whenever
possible, you will be notified in advance of any changes, especially those affecting course requirements or grading.
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Unit/
Begin
Date
Topical Outline
Learning Resources
Unit 1
History of Clinical Research
Read:
 Define clinical research
 Gallin – Chapter 1: A Historical
Perspective on Clinical Research
 Explore the evolution of
clinical research from the
 The Tuskegee Timeline. Centers for
beginnings of civilization.
Disease Control and Prevention – US
Public Health Service Syphilis Study at
 Discuss key historical
Tuskegee research cases and how they
http://www.cdc.gov/tuskegee/timeline.ht
have contributed to
m
advances in medicine and
shaped today’s version of
 Research Implications. Centers for
the clinical trial.
Disease Control and Prevention – US
Public Health Service Syphilis Study at
 Discuss current research.
Tuskegee http://www.cdc.gov/tuskegee/after.htm
 Jacobsen – Chapter 1
Activities/Assignments
Group Classroom Discussion:
Open the class with a discussion
of what clinical research is.
Explore the students’ perceptions
of the following:
-What is the definition of clinical
research?
-What is the purpose of clinical
research?
- What are the benefits of
conducting clinical research?
Optional Lesson Extension:
Movie “Miss Ever’s Boys”
Homework/Assignment:
Complete Review Questions
Review/Listen:
 Remembering Tuskegee - Syphilis Study
Still Provokes Disbelief, Sadness. Alex
Chadwick. National Public Radio (NPR) Complete Unit 1 Quiz
Report – July 22, 2002 http://www.npr.org/programs/morning/fe
atures/2002/jul/tuskegee/
Unit 2
Overview of Clinical Research
 Know what research is and
is not.
Read:
 Nesbitt – Chapter 1
 Understanding Research Study Designs.
Homework/Assignment: New
Terminology
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





Unit 3
Describe the various types
of health research.
Identify the goals of heath
research.
List and describe the five
basic steps of the research
process.
Describe the basic steps of
the scientific research
process.
Define clinical research and
its purpose.
Describe various types of
research study designs
including observational
studies and clinical trials.
Explain the key elements of
the four phases of clinical
trials.
Identify the five steps of the
research process
University of Minnesota – BioMedical
Library 


Terms to know: Study Designs
Clinical Study
Interventional Study
http://hsl.lib.umn.edu/biomed/help/under Observational Study
Case Control
standing-research-study-designs LIVE
Case Series
1/31/2013
Ecological Study
Understanding Clinical Trials. Clinical Aggregate Study
Trials.gov- National Institutes of Health Meta-analysis
Logitudinal Cohort Study
http://clinicaltrials.gov/ct2/info/understa Retroactive Cohort
Cross-sectional
nd#Q01
Double-blind Study
Randomized Control Trials
Jacobsen - Chapter 1-29 (Pg. 10)
Population Based Research
Step one - Chapter 2
Step two - Chapter 6
Step Three - Chapter 15
Step Four - Chapter 25
Complete Unit 2 Quiz
Step five - Chapter 29

Blessing – Chapter 1,6,7,8,10,12
Ethics in Clinical Research
Read:
 Discuss principles of the
 Nesbitt – Chapter 2
ethical framework for
 Gallin –
clinical research: Value and
Chapters 2 : Ethical Principals in
Validity, Fair Subject
Clinical Research
Selection, Favorable RiskChapter 5: Institutional Review Boards
Benefit Ratio, Independent
 Jacobsen – Chapter 21 & 22
Review, Informed Consent,
 Blessing – Chapter 3.4
and Respect for Enrolled
Subjects.
 Describe the purpose of a
Homework/Assignment:
Complete Review Questions
Terms to Know: Ethics
Value and Validity
Fair Subject Selection
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
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
Unit 4
Patient Informed Consent
Form.
Identify the key information
included in Patient
Informed Consent forms.
Explain the role and
functions of the
Investigational Review
Board (IRB).
The Clinical Research Landscape: Read:
regulatory agencies, research
 Nesbitt – Chapter 3, 9
personnel, research sites, contract
 Gallinresearch organizations, the
Chapter 9 Data and Safety Monitoring
pharmaceutical industry
Chapter 26 (pg. 350-356)
 List the various
Chapter 37 Pharmaceutical Research
organizations involved in
 Jacobsen – Chapter 22
the development and
 Blessing – Chapter 11
conduct of a clinical trial.
 Describe the role of the
Food and Drug
Administration in drug
discovery and development.
 Identify key clinical
research personnel at the
study sites.
 Distinguish between
government-sponsored and
industry-sponsored clinical
Favorable Risk-Benefit Ratio
Beneficence
Non-maleficence
Justice
Respect for Enrolled Subjects
Independent Review
Informed Consent
Institutional Review Board
OHRP Office of Human
Research Protection
Nuremberg Code
Belmont Report
Complete Unit 3 Quiz
Homework/Assignment:
Complete Review Questions
Terms to Know: Research
Principal Author
Principal Investigator
FDA
IRB
Clinical Trial Sponsor
CRO Clinical Research Org
Study Monitors
Terms to Know: Pharmaceutical
(Gallin p 546-550)
Efficacy
Safety
Pharmacovigilance
Fast Track Approval
Placebo
Placebo effect
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
Unit 5
Unit 6
research.
Define the components of
the pharmaceutical industry
and discuss the challenges
under which the
components operate.
Complete Unit 4 Quiz
Clinical Research from the
Read:
Perspective of the Patient
 Nesbitt – Chapter 7
 Explore the reasons that
 Gallin –
motivate patients to
Chapter 13 Women and Minorities
participate in clinical
Chapter 17 Patient’s Perspective
research.
 Jacobsen – Chapter 19
 Explain why certain
populations are
underrepresented in clinical
trials.
 Describe strategies for
effective communication
with patients in clinical
research and how this can
improve the recruitment
process as well as retention.
Homework/Assignment:
Complete Review Questions
Clinical Trial Protocol and
Implementation
 Explain the elements of a
clinical trial protocol.
 Develop a concept for a
clinical trial and write a
protocol concept document
to implement it.
 Discuss the processes
Homework/Assignment:
Complete Review Questions
Read:
 Nesbitt – Chapter 4
Gallin Chapter 32 Writing a Protocol
 Jacobsen – throughout
 Blessing – Chapter 5,9
Complete Unit 5 Quiz
Complete Unit 6 Quiz
9
involved in initiating,
maintaining, and closing out
a clinical trial.
Unit 7
Data Management
Read:
 Outline the process of
 Nesbitt – Chapter 5
patient data collection in
 Gallin –
clinical research.
Chapters 7 Food and Drug
 Explain the importance of
Administration
effectively monitoring,
Chapter 8: Data Management in Clinical
reviewing, and evaluating
Trials
patient data.
Chapter 26 Large Clinical Trials and
Registries -Clinical Research Institutes
 Describe various methods
of Statistical Analysis
 HIPAA Research Presentation. U.S.
Department of Health and Human
 Describe how the Health
Services Insurance Portability and
http://www.hhs.gov/ocr/privacy/hipaa/un
Accountability Act
derstanding/training/researchppt.pdf
(HIPAA) regulation applies
to research participants.
 Jacobsen Chapter 25
 Blessing – Chapter 14, 15
Homework/Assignment:
Complete Review Questions
Terms to know: Statistics
Odds Ratio (OR)
Risk Ratio (RR)
Correlation
Prevalence
Terms to know: Data
Validity
Reliability
Quantitative Data
Qualitative Data
Feasibility
Health Insurance Portability and
Accountability Act (HIPAA)
Complete Unit 7 Quiz
Unit 8
Clinical Quality Control and
Assurance
 Explain the purpose and
importance of quality
management.
 Identify the steps in
preparing for an audit.
Read:
 Nesbitt – Chapter 5
 Gallin –
Chapters 7 Food and Drug
Administration
Chapter 8: Data Management in Clinical
Trials
Homework/Assignment:
Complete Review Questions
Terms to Know:
Good Clinical Practice (GCP)
guidelines
Complete Unit 8 Quiz
10

Unit 9
Describe the Good Clinical
Practice (GCP) guidelines
and explain the importance
of complying with GCPs in
clinical research.
Chapter 26 Large Clinical Trials and
Registries-Clinical Research Institutes
Clinical Drug Safety and Adverse
Event Reporting
 Describe what constitutes a
Serious Adverse Event
(SAE) and identify the
appropriate steps for
reporting it.
 Discuss the role and
functions of Data and
Safety Monitoring Boards
(DSMB).
Read:
 Gallin – Chapter 6 (page 75)
 Jacobsen – Chapters 13 & 22
Unit 10
Business of Clinical Research
 Describe what factors to
consider when establishing
and evaluating clinical
study budgets.
 Explain the purpose of a
Clinical Trial Agreement
and discuss the key
elements of this document.
Read:
Homework/Assignment:
Complete Review Questions
 Nesbitt – Chapter 8
 GallinChapter 33 Evaluating a Protocol Budget
 Jacobsen -throughout
Complete Unit 10 Quiz
Unit 11
Writing and Publishing in the
Health Professions
 Identify what is written in
an abstract.
 Identify the types of
presentations.
Read:
 Jacobsen – Chapter 29 - 35
 Blessing Chapter 18
Homework/Assignment:
Complete Review Questions
Terms to Know:Adverse Events
Serious Adverse Event (SAE)
Complete Unit 9 Quiz
Homework/Assignment:
Complete Review Questions
Complete Unit 11 Quiz
11


Understand the need for
disseminating one’s
research findings.
Understand how to write a
well-prepared research
paper and the components
of a research paper
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