Quality Control (QC)

Quality control refers to the procedures within the internal quality assurance system used to ensure that the quality verification for trial-related activities- data and form checks, monitoring, reporting of deviations, corrective action- meet the requirements according to the protocol, standard operating procedures, and GCP.

The sponsor is responsible for implementing and maintaining quality control systems by providing written standard operating procedures. Quality control should be applied to every stage of data handling to ensure data reliability and processing.

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