Quality Assurance (QA)

All planned and systematic actions established to ensure that the data are generated, documented, and reported in compliance with the protocol, good clinical practice (GCP) standards, and applicable regulatory requirements.

The sponsor is responsible for implementing quality assurance and providing written standard operating procedures for the same. Audits may be performed by sponsors as a part of implementing quality assurance.

Source: Food and Drug Administration (FDA). (2020, May). E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). US Department of Health & Human Services. https://www.hhs.gov/guidance/document/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1