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Training Course for Clinical Research Coordinators
The primary objective
of this one-day course will be to instruct participants
in the role that a clinical research coordinator plays
in the process of new drug development. This will
be achieved by a series of lectures covering background
and regulatory issues, and an interactive workshop designed
to provoke thought and in-depth discussions. Students
who complete the course will have gained a comprehensive
understanding of CRC responsibilities and the kinds of
problems and issues that they will face when involved
with clinical trials.
The
next CRC course is not currently scheduled but contact us if you are interested.
Course
Outline
ORIENTATION
- Course
Outline
- Commonly
Used Terms
- Historical
Perspective
OVERVIEW
OF THE REGULATORY PROCESS
THE
CLINICAL TRIAL PROCESS
- Laboratory
and Pre-Clinical Testing
- The
Protocol
- Requirements
for IND Submission
- Site
Visits
DATA
MANAGEMENT
STATISTICAL
ISSUES
ROLE
OF THE CRC
- Reporting
and Recording Adverse Events
- Completion
of Case Report Forms
- Good
Clinical Practices
- Investigator's
Study File
- The
Data Clarification Process
WORKSHOP - Putting Your Knowledge
into Practice
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