Skip to main content

Essential document

« Back to Glossary Index

A document which individually and collectively permits evaluation of the conduct of a study and the quality of the data produced. Essential documents serve to demonstrate the compliance of the investigator and sponsor while monitoring the standards of Good Clinical Practice (GCP) with all applicable regulatory requirements. Examples include, but are not limited to, source documents, monitoring reports, IRB approval letters, and study logs. ICH GCP, 1.23, 8.


« Back to Glossary Index