This module was released in October 2026.

Module 3.1 - Introduction to Data Governance

Key questions you will be able to answer after completing this module include:

• What is data governance and why is it important in clinical trials?
• Why was a new section on data governance introduced in ICH E6(R3)?
• How does the data governance section align with sponsor and investigator responsibilities in ICH E6(R3)?

Module 3.2 - Risk-Proportionate Approach to Data Governance

Key questions you will be able to answer after completing this module include:

• How does the concept of risk proportionality apply to data governance?
• What are the key steps in implementing a risk -based approach to data governance?
• How can mapping and analysing data flows help identify critical to quality factors?

Module 3.3 - Risk-Appropriate Approach to Management of Computerised Systems

Key questions you will be able to answer after completing this module include:

• How should a risk -proportionate approach be applied to managing computerised systems in a clinical trial?
• What are the responsibilities of sponsors and investigators for managing computerized systems?

Module 3.4 - Data Lifecycle Management

Key questions you will be able to answer after completing this module include:

• What are the general requirements for managing data across each step of the data lifecycle?
• What responsibilities do investigators and sponsors have throughout the data lifecycle?
• How can investigators and sponsors tailor their management and oversight throughout the data lifecycle based on risks that may impact critical to quality factors?