| The
Role of the CRA
The
primary objective of this three-day course will be to
instruct participants in the role that a clinical research
associate plays in the process of new drug development.
This will be achieved by a combination of lectures covering
background and regulatory issues, and a series of interactive
workshops designed to provoke thought and in-depth discussions.
Students who complete the course will have gained hands-on
experience in dealing with problems and handling issues
associated with the performance of clinical trials.
The
next CRA 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
DATA
MANAGEMENT
WORKSHOP – Critique a Study Design
THE
CLINICAL TRIAL PROCESS
- Laboratory
and Pre-Clinical Testing
- The
Protocol
- Requirements
for IND Submission
- Site
Visits
WORKSHOP
– Communication Skills
STATISTICS
ROLE
OF THE MONITOR
- Reporting
Adverse Events
- Monitoring
CRFs
- Investigators
Study File
- Good
Clinical Practices
WORKSHOP
– Monitoring a CRF
CASE
REPORT FORM DESIGN
ROLE
OF THE MONITOR
- Handling
Study Data
- The
Data Clarification Process
- Writing
Queries
MONITORING
IN PRACTICE
- The
Site Initiation Visit
- Routine
Monitoring Visits
- The
Study Site Close-Out Visit
- Practical
Aspects of Monitoring
WORKSHOP
– Design a Study
WORKSHOP – Putting Your Knowledge into Practice
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