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Investigator Site File Document Templates


High quality clinical trials, conducted as per GCP standards, require consistent approaches to data collection and trial management.

The use and filing of regulatory documents in an Investigator Site File (ISF) is mandatory for both Investigator Initiated and Sponsored clinical trials.

Any CALHN RGO, TGA, FDA or sponsor audits will request to see these documents.

The National Clinical Trials Governance Framework assessors will be choosing 30 clinical trials, focusing on Investigator Initiated Clinical Trials to assess under the NSQHS accreditation assessment. These documents will form part of evidence to show good clinical trial governance.

Please find below, CALHN developed templates for use if you do not have access to these documents, to ensure compliance.

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