Key Items Auditors Look For When Reviewing An Investigator Site File

By Amanda Bourgeois, Director

Delve into the intricacies of investigator site files (ISF) and their pivotal role in clinical trial audits. This comprehensive overview sheds light on the critical components auditors meticulously examine, ranging from delegation logs to IRB communications and training documentation. Gain insights into common pitfalls to avoid and best practices for maintaining compliant documentation.

Whether you're gearing up for an audit or aiming to streamline ISF management, this detailed guide equips you with invaluable knowledge to ensure regulatory compliance and facilitate a seamless audit process. Explore the nuances of electronic versus paper documentation, and understand the importance of accessibility and organization in facilitating inspections. With practical tips and expert advice, navigate the complexities of ISF preparation with confidence, ensuring your documentation stands up to scrutiny and contributes to the success of your clinical trial endeavors.