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Session # 13 | Good clinical practices
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Course Content
Introduction
Law
Guidelines
Glossary
1 Quiz
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Session Content
1st Question – Good clinical practices
Glossary (Cont.)
The Principles of ICH GCP
Institutional Review Board Independent Ethics Committee
Sponsor
Investigator
Clinical Trial Protocol and Protocol Amendments
1 Quiz
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Session Content
2nd Question – Good clinical practices
Clinical Trial Protocol and Protocol Amendments (Cont.)
Investigator´s Brochure
Essential Documents for The Conduct of a Clinical Trial
Clinical Trials
Clinical Trials Classification
The Clinical Trial in The Clinical Trial Center
Research Team
Recruitment Period
Follow-up Period
1 Quiz
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Session Content
3rd Question – Good clinical practices
Follow-up Period (Cont.)
1 Quiz
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Session Content
4th Question – Good clinical practices
Adverse Events
Strategies to Achieve a Good Performace
Good Documentation Practices
Poor Bad Clinical Practices
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