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Human Clinical Investigation: Theory

Clinicians trained in the basics of human clinical investigation are needed to design and initiate clinical trials in academic medicine and in the pharmaceutical industry.

The Certificate Program in Human Clinical Investigation: Theory will provide the core competencies and skills needed for those interested in clinical research or careers in academic medicine. This program is designed for clinicians, but could be taken by other interested in understanding the theory behind clinical trial design.

The objectives of this certificate option are:

  • To provide the theory behind the design of human clinical studies and appropriate design and use of databases.

  • To educate on the ethics and regulations governing clinical research

  • To provide a background in statistics and epidemiology necessary for human clinical investigation

Core Courses

GC 660 Statistical Methods of Data Analysis
3 credits
GC 630 Fundamentals of Clinical Trials (GC 660 is pre-requisite)
3 credits

MI 580

Epidemiology (GC 660 is pre-requisite)

3 credits

GC 510

Database Designs and Management

2 credits

GC 640

Research Ethics and Responsible Conduct

1 credit

GC 690 Regulatory Issues in Human Subject Research
2 credits 
Core Total
14 credits 

Select 3 Credits from the Following *

PR 525

Clinical Pharmacology

3 credits

GC 515 Quality Measures/Outcomes Analysis in Healthcare
3 credits

GC 650

Economic Analysis of Healthcare Interventions

3 credits

GC 654

Pharmacoepidemiology

2 credits

PR 810,
820, 830

Pharmacology Clerkship Credits – only available for clinicians starting in the MSPR program and changing to the Certificate program

1-3 credits

Elective Total
3 credits
Certificate Total
17 credits

Who May Attend

Persons with scientific/medical background or experience who are interested in careers in clinical research. This certificate is most relevant to individuals with clinical backgrounds who are interested in being involved in human clinical research and leading research teams. This certificate focuses on the theory rather than the implementation. This certificate program is the didactic component of the MS Pharmacology program, Human Clinical Investigation track (no thesis is required for the certificate).

* Other courses may be substituted upon approval.
However, no substitutions can be made for clinicians wanting to transfer these credits into the Human Clinical Investigation track of the Master of Science in Pharmacology.

Further information


Please contact Eleanor Gorman, Assistant Coordinator for Master's Programs in the Basic Sciences, by e-mail or by telephone at 215 503-5799.




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