Essential Documents vs. Expected Documents vs. Required Documents

By Avani Amin, Associate Director, Client Solutions

What's the difference between Essential documents, Expected documents, and Required documents?

Essential Documents: According to ICH GCP Section 8, “Essential documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements.” Simply stated, essential documents are documents that are needed to recreate the trial and its results. Section R8 provides us with some guidance on the types of documents that are essential to recreate the trial and demonstrate integrity of the trial data. However, this is not an inclusive list, and it needs consideration to determine which documents are expected vs. required during TMF setup.