Set up and maintenance of the Investigator Site File

A process for sites for generating important documents and a systematic filing system

 

 

Publication Version
2.0
Publication Code
AD02
Procedure Author
WWARN

An investigator is required to maintain trial documents in way that prevents their accidental or premature destruction. As such, site should have a process for generating important documents and a systematic filing system to follow (usually called an Investigator Site File, ISF). This procedure therefore applies to those team members responsible for generating such documents and/or setting up/maintaining an ISF.

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