ICH E6 Guideline for Good Clinical Practice

documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced

they serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP adn with all applicable requirements

• they assist in the management of a trial by the investigator, sponsor and monitor
• they are usually audited by and independent auditor and inspected by regulatory authorities to confirm the validity of the trial and integrity of the data