Section 4 of Annex 1 of the ICH GCP E6(R3) Guideline for Good Clinical Practice provides guidance for investigators and sponsors on the appropriate management of data integrity, traceability and security. This enables the accurate reporting, verification and interpretation of clinical trial-related information.

Investigators should read Section 4 of E6(R3) Annex 1 in conjunction with their responsibilities defined in Section 2. Additional important information is also provided in other ICH guidelines, such as E8(R1) on general considerations and E9 and E9(R1) on statistical principles.

This short guide summarises the key data governance responsibilities for the Investigator site.

Author: Prof Dr David Hutchinson