ICH GCP E6 R3 Training & Certification

Implementing ICH GCP E6 R3 covering Compliance to Implementation

ICH GCP E6 R3 Unlocked. Equip yourself with tailored insights, practical tools for effective & pragmatic understanding and implementation.

1. 1.1 Welcome and the course set up explained! (5mins)
2. 1.2 How to use the AI Coach! (5mins)
3. 1.3 Introduction to ICH GCP E6 R3 (5mins)
  FREE PREVIEW
4. 1.3.1 GCP Explained for Beginners (3mins)
5. 1.4 ICH GCP E6 R3 Survey (1min)
6. 1.5 Core Principles and Ethics in ICH GCP E6 (R3) (15-20mins)
7. 1.6 Global Implementation Timelines (2mins)
  FREE PREVIEW
8. Foundational Quiz (5mins)
9. Downloadable Materials
  FREE PREVIEW
1. 2.0 Overview of Sponsor Responsibility (2mins)
2. 2.1 Sponsor Responsibilities (10mins)
3. Quiz (5mins)
4. 2.1.1 Decentralized Clinical Trials (DCTs) & Digital Health Technologies (DHT) (5mins)
  FREE PREVIEW
5. 2.1.2 Service Provider Oversight and Compliance
  FREE PREVIEW
6. 2.2 Investigator Responsibilities (10-15mins)
7. 2.3 IRB/IEC Responsibilities (10-15mins)
8. 2.4 Monitoring Responsibilities (10-15mins)
9. 2.5 QA and Auditing Responsibilities (10-15mins)
10. Responsibility Test
1. 3.1 QMS & Quality by Design (QbD): A Proactive Approach to Reliable Clinical Trials (10mins)
2. 3.2 Embedding Proportionality in Clinical Trials (9mins)
  FREE PREVIEW
3. 3.3 Dynamic Risk Based Management in Clinical Trials (6mins)
4. RDM Quiz
1. 4.1 Data Governance: Ensuring Data Integrity and Traceability (10mins)
2. Data Governance Quiz
3. 4.2 Validation and Technology (10mins)
4. Validation and Technology Quiz
5. Feedback Survey

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