Set up and maintenance of the Investigator Site File

How to generate important site documents and a systematic filing system

 

 

Publication Version
2.0
Publication Code
AD02
Procedure Author
WWARN

Trial investigators need to maintain trial documents to prevent their accidental or premature destruction. Trial sites therefore need a process for generating important documents and a systematic filing system to follow (usually called an Investigator Site File, ISF). Use this procedure if you are responsible for generating  these documents and/or setting up/maintaining an ISF.

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