ICH harmonised tripartite guideline: guideline for good clinical practice. 8. Essential documents for the conduct of a clinical trial.

Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor, and monitor. These documents are also the ones that are usually audited by the sponsor's independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected.