By Claudia Malcolm, Director of GCP Services
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.