October 27

Operationalizing ICH E6(R3) Data Governance

Tuesday, November 17, 12 PM - 1 PM

ICH E6(R3) introduces, for the first time, a dedicated data governance section that provides guidance on the appropriate management of data integrity, traceability, and security to enable accurate reporting, verification, and interpretation of clinical trial-related information. Data governance addresses how data are managed, protected, and maintained throughout the data lifecycle. 

Why is data governance important for clinical trial quality? 

Effective, risk-proportionate data governance ensures the information generated in the clinical trial is fit for purpose and sufficient to provide confidence in the trial’s results and support good decision-making. 

How do sponsors and investigators achieve effective data governance?

This webinar brings together three members of the ICH E6(R3) Expert Working Group who wrote the guideline to break down Section 4, Data Governance, of the E6(R3) guideline. Together, they will discuss:

• Why was this section added, and what are the foundational concepts of clinical trial data governance, including key principles and new terminology 
• How do trial design, protocol development, and trial conduct influence risk-proportionate management of the data throughout the trial? 
• What are the sponsor and investigator roles and responsibilities related to data governance? 
• How is data traceability maintained throughout the data lifecycle 
• How are confidentiality, blinding, computerized systems, and key decision-making processes protected throughout the data lifecycle, recognizing that vulnerabilities can arise at each data lifecycle stage 

Panelists:  

• Lisbeth Bregnhøj, member of the ICH E6(R3) Expert Working Group. 
• Andy Fisher, Lead Senior GCP Inspector, UK Medicines and Healthcare products Regulatory Agency; and  
• Cheryl Grandinetti, Associate Director for Clinical Policy, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, CDER, FDA, and FDA Topic Lead for ICH E6(R3);  
• Sarah White, Executive Director of the MRCT Center, will moderate. 

The webinar builds on Data Governance (Module 3) of the MRCT Center's free ICH E6(R3) training.