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Training on “International Council on Harmonisation Good Clinical Practice (ICH GCP)”

  • Event Type

    Training

  • Venue

    Auditorium 2 (AMRC), Department of Medical Research, Yangon

  • Date

    13-14 February 2020

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ICH GCP (1)

Objectives

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Agenda / Program

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List of Participants

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Documents

1. Introduction to ICH-GCP
2. Introduction to GCP
3. Research Ethics and GCP
4. Basic Statistical Concept and Study Design
5. Research Protocol in Clinical Trials
6. CRF and Data Management 2020
7. Documentation and Archiving
8. Research Misconduct and Fraud
9. Quality Management
10. Informed consent and safety reporting
11. Risk-based Monitoring
12. Reviewing Clinical Trials
13. IRB Submission Processes

 

 

 

 

 

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