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Governance Annual Snapshot Reconciliation Action Plan Disability Access and Inclusion Plan Diversity and Inclusion Action Plan Professional Accountability Program Research Services Office Researchers and sponsors Research participants Clinical trials Grants and funding News and events Clinical Strategy Strategic Ambition Consumer Strategy Aboriginal Employment Strategy Research Strategy Concerns about your care Informed consent Consumer experience Consumer partnering Compliments and complaints Your rights as a patient Aboriginal and Torres Strait Islander Health

Investigator site file document templates

Essential documents that are mandated for ensuring study compliance across all investigator initiated and sponsored clinical trials

High quality clinical trials require a consistent approach 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.

National Clinical Trials Governance Framework (NCTGF) assessors will choose 30 clinical trials, focusing on investigator initiated clinical trials to assess under the NSQHS accreditation assessment.

The documents below will be requested if an audit of your trial takes place to demonstrate evidence of good clinical trial governance and overall compliance.

Templates

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Clinical trials accreditation

Good Clinical Practice (GCP) training
Research education
Compliance with the National Clinical Trials Governance Framework (NCTGF)

National Clinical Trials Governance Framework (NCTGF)

A comprehensive set of guidelines to ensure clinical trials are conducted in a safe and high-quality environment for patients and the community.

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Human Research Ethics Committee (HREC) submissions

Learn more about CALHN HREC and its approval processes

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Research governance

CALHN research governance details and submissions.

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This page was last updated 16 May 2025.

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