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Courses
GCP Trainings
Good Clinical Practices (ICH Focused)
Curriculum
10 Sections
10 Lessons
20 Hours
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Module 1
2
1.1
Introduction, Scope, and Fundamental Principles of ICH E6(R3)
1.2
Questionnaire
7 Questions
Module 2
2
2.1
Institutional Review Board/Independent Ethics Committee (IRB/IEC)
2.2
Questionnaire
7 Questions
Module 3
2
3.1
Investigator Responsibilities and Trial Conduct
3.2
Questionnaire
7 Questions
Module 4
2
4.1
Sponsor Responsibilities and Oversight
4.2
Questionnaire
7 Questions
Module 5
2
5.1
Data Governance – Investigator And Sponsor
5.2
Questionnaire
8 Questions
Module 6
2
6.1
Investigator’s Brochure Requirements And Management
6.2
Questionnaire
8 Questions
Module 7
2
7.1
Clinical Trial Protocol and Amendments
7.2
Questionnaire
8 Questions
Module 8
2
8.1
Essential Records For The Conduct Of A Clinical Trial
8.2
Questionnaire
8 Questions
Module 9
2
9.1
Glossary And Key Definitions
9.2
Questionnaire
8 Questions
Module 10
2
10.1
Implementation and Risk-based Approches
10.2
Questionnaire
8 Questions
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