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ICH E6 GCP (R3) Training
Introduction
Introduction (1:06)
Training Objectives
Training Objectives (1:26)
ICH-GCP Definition and Principles
ICH-GCP Definition and Principles (14:17)
Ethics Committees
Ethics Committees (3:31)
Investigator
Investigator (26:24)
Sponsor
Sponsor (27:42)
Data governance
Data governance (7:18)
Essential Documents
Essential Documents (1:59)
Audit ICH-GCP Compliance
Audit ICH-GCP Compliance (3:07)
Q&A
Do we need to update SOPs or QMS to reflect R3? (2:40)
How does R3 apply to trials already running under R2? (1:53)
Based on the R3 changes, there are changes on the CTIS process? (1:01)
What is the first step to implement in order to become more compliant with R3? (1:50)
What about service provider? (2:03)
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Final quiz
Final Quiz
Based on the R3 changes, there are changes on the CTIS process?
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