Which term describes documents that permit evaluation of the conduct of a study and the quality of the data produced?

• A. Documentation
• B. Impartial Witness
• C. Informed Consent
• D. Institution (Medical)

Answer: (A)

Documentation is the set of records that show how a study was conducted and the quality of the data produced, allowing others to evaluate both the conduct of the trial and the resulting data. In GCP, this includes source documents, case report forms, the trial master file, monitoring reports, and related records that demonstrate what happened and why. The other terms refer to a person (impartial witness), the consent process (informed consent), or the site/institution, none of which are the documents that permit evaluation of the study and data.