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ICH E6 (R2) Investigator Site Personnel Training
Introduction
Introduction to Pharma Training Hub, ClinOpsHub CRO and Meet Your Trainers (2:54)
The importance of GCP training and TransCelerate Certificate Compliance (1:17)
The Agenda (0:30)
Section 1: Main Stakeholders in Clinical Research
Stakeholder Definitions (3:05)
Who are the Main Stakeholders? (0:50)
Review Quiz 1
Section 2: Good Clinical Practice (GCP) (a Brief Summary)
E6 - Efficacy Guidelines (3:24)
GCP Definition and Introduction to ICH (2:03)
Guidelines, Local Law, Regulations (1:22)
Why? The declaration of Helsinki (3:39)
Why Was a Revision 2 Necessary? (2:03)
The 8 GCP Chapters (3:03)
Review Quiz 2
Section 3: The Principles of GCP
The Trial Centre (4:14)
The Fundamental Principles (2:03)
Review Quiz 3
Section 4: Investigator Responsibilities
Quality Control (2:36)
Investigator's Responsibility (2:10)
Adequate Resources (4.2) (1:37)
Medical Care of Trial Subjects (4.3) (1:34)
Communication with IRB-IEC (4.4) (1:48)
Compliance with Protocol (4.5) Part 1 (0:24)
Investigator Statement (signature page) (2:50)
Compliance with Protocol (4.5) Part 2 (1:36)
Investigational Product(s) (4.6) (1:17)
Randomization Procedures and Unblinding (4.7) (0:46)
Informed Consent of Trial Subject (4.8) (6:48)
Vulnerable Subjects (1.61) (3:30)
Informed Consent of Trial Subject (4.8) Part 2 (2:46)
Records and Reports (4.9) (7:16)
Progress Reports and Final Reports (4.10, 4.13) (2:00)
Safety Reporting (4.11) (4:00)
Early Trial Termination (4.12) and Course Conclusion (3:30)
Final graded QUIZ
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Why Was a Revision 2 Necessary?
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