What Goes Into An Investigator Site File?

The investigator site file (ISF) plays a critical role in a study’s success. But only if the people in charge of it – clinical trial investigators – keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF.

Investigators have a few responsibilities. They control the drugs under investigation. They verify informed patient consent. They protect the rights and welfare of the patients under their care. They make sure the study is conducted according to the signed investigator statement, investigational plan and all applicable regulations. And they have to ensure institutional review board (IRB) review, approval and reporting requirements are met.

But above all else, investigators are responsible for preserving all data relating to a study before, during and after its completion. If they don’t, it can mean FDA warning letters, disqualifications or restrictions and, in extreme cases, even criminal prosecutions. This is why an ISF is so important – but can also be so daunting.