12 Items Auditors Look for When Reviewing an Investigator Site File

Meghan Hosely
July 9th, 2020

Maintaining complete, compliant documentation on top of managing the complex processes and interactions of clinical trial conduct can be challenging. However, a complete investigator site file (ISF) helps auditors evaluate trial conduct by ensuring the minimum requirements of ICH E6 (R2) section 8 are met and checking for the presence and content of a variety of documents. Incomplete documentation could lead to regulatory inspection findings such as a Form FDA 483.

The full article on Advarra’s website outlines the details to look out for when preparing your ISF for an audit.

Read the article