HOW
TO COORDINATE CLINICAL TRIALS:
THE BASICS
Day
1: How New Drugs are Developed Overview
of Good Clinical Practices (GCP's) under FDA and ICH
- Roles/Responsibilities
of the Professionals Directly Involved with Clinical Trials
Starting
a Study
- Preparing
for the Sponsor's Site Visit
- Dealing with
Informed Consents
- Communicating
with the Institutional Review Board (IRB)
- Setting up
Study Files
- GCP Summary
Day
2: Coordinating a Study
Preparing
for a Study Initiation Visit
- Recruiting
Subjects
- Collecting/Recording
Data
- Source Documents
- Case Report
Form
- Adverse Experience
- Handling
Monitoring Visits
- Managing
the Investigative Drug
- GCP Summary
Closing a
Study
*Manual Includes
both FDA and ICH Guidelines
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