Which term best describes documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced?

• A. Documentation
• B. Informed Consent
• C. Inspection
• D. Essential Documents

Answer: (A)

Essential documents are the records that individually and collectively permit evaluation of the conduct of the trial and the quality of the data produced. This defined set includes items such as the protocol and any amendments, ethics committee approvals, investigator’s brochure, informed consent forms, source documents, case report forms, and regulatory correspondence. They provide the documentary basis that the study was conducted according to GCP and that the data are credible. A generic term like documentation is too broad, and an individual document like informed consent covers only one piece of the whole picture. An inspection is an activity, not a type of document. Therefore, the best term for this concept is essential documents.