Article | July 22, 2020

12 Items Auditors Look For When Reviewing An Investigator Site File

Source: Advarra

By Claudia Malcolm, Director of GCP Services

audit

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for when preparing your investigator site files (ISF) for an audit. 

The ISF contains essential documents that permit evaluation of the conduct of the clinical trial. In addition to checking that the minimum requirements stated in ICH E6 (R2) section 8 are met, auditors also check the presence and content of a variety of documents. Essentially, the auditor should be able to “reconstruct” the trial based on the documentation in place at the site. If documentation is incomplete, sites run the risk of regulatory inspection findings such as a Form FDA 483. Below are examples of specifically what auditors/inspectors are looking for during an audit.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Clinical Leader? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: