Conducting clinical trials

  1. ​Investigator Site File

​Investigator Site File

Understand the importance of an Investigator Site File in a clinical trial. 

Investigator Site File

An Investigator Site File (ISF) should be established at the beginning of each clinical trial. The ISF contains the minimum list of essential documents that have to be maintained throughout the clinical trial.

Refer to Section 8 of the ICH E6 (R2) Good Clinical Practice for further guidance.

Refer to our ISF Content Page template for more details.