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Investigator Site file (ISF) Template NonIMP Studies v 5.8 22.12.2010File ContentsStudy Information/Contact Page Section 1 General Correspondence Section 2 Study personnel Section 3 Screening and
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The Investigator Site File (ISF) is a collection of essential documents and records that are maintained by the clinical trial investigator at the trial site.
The clinical trial investigator is required to file and maintain the Investigator Site File (ISF).
The Investigator Site File (ISF) should be filled out by the clinical trial investigator according to regulatory requirements and sponsor instructions.
The purpose of the Investigator Site File (ISF) is to ensure that all essential documents and records related to the conduct of the clinical trial are maintained and readily available for inspection.
The Investigator Site File (ISF) must include essential documents such as the signed protocol, informed consent forms, and relevant correspondence.
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