Research Roundup: FDA Uses Fall and Winter 2021 to Release Significant New Guidance Governing Hot-Button Life Sciences Research Topics
Arnold Porter
DECEMBER 20, 2021
Among these relevant “governance attributes” is Part 11 compliance, as applicable, including maintaining “access controls and audit trails to demonstrate the provenance of the registry data and to support traceability of the data. ”[[N:Id. 2021) (Investigator Responsibilities Draft Guidance). 2009) (2009 Guidance).
Let's personalize your content