GCP & Pharmacovigilance Compliance Symposium | D1S04 - Good Data Governance Practice Updates

Описание: These presentations discussed the risk proportionate approach to data governance and emphasized the importance of good data governance practices in clinical trial conduct. This session provided updates to ICH E6R3 related to data governance, including revised sponsor and investigator responsibilities. Case examples were included to illustrate the importance of new draft recommendations in E6R3 related to data governance implementation and compliance.

Timestamps

02:03 – ICH E6 (R3) - Risk Proportionate Approach

04:15 – Risk Proportionate Approach to Data Governance

07:26 – Risk Proportionate Approach Throughout the Data Lifecycle

09:24 – Importance of Data Governance: ICH E6 (R3)

11:27 – Processes for Full Data Life Cycle

13:30 – Investigator and Sponsor Responsibility for Data and Records

15:58 – Responsibilities for Computerized Systems

18:39 – Validation Principles

24:28 – Critical to Quality Factors

26:36 – What Does ICH E6 (R3) Say About Trial Participant Confidentiality

28:06 – Risk Proportionate Approach to Data Governance: Case Example on Maintaining Participant Confidentiality

37:59 – Risk Proportionate Approach to Data Governance: Case Example on Defining and Documenting Data Finalization Prior to Analysis

42:56 – Safeguarding the Trial Blinding

44:04 – Risk Proportionate Approach to Data Governance: Case Example on Maintaining the Integrity of the Blind

52:41 – Closing Thoughts

Moderator:

Shila Rastegar, MSc
Regulatory Compliance and Enforcement Specialist
Clinical Trial Compliance Program (CTCP)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada (HC)

Speakers:

Cheryl Grandinetti, PharmD
Clinical Pharmacologist
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

Andrew Fisher, BSc
Lead Senior Good Clinical Practice (GCP) Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)

Learn more at: https://www.fda.gov/drugs/news-events...

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