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.
Any audits will request to see these documents.
National Clinical Trials Governance Framework assessors will choose 30 clinical trials, focusing on investigator initiated clinical trials to assess under the NSQHS accreditation assessment. These documents will demonstrate evidence of good clinical trial governance.
Please find below templates for study team use to ensure overall compliance.
Templates
- Investigator initated staff site contact list (96KB DOCX)
- Investigator initiated screening and enrolment log (278KB DOCX)
- Investigator initiated participant identification log (73KB DOCX)
- Investigator initiated study site files table of contents (266KB DOCX)
- RGO research services investigator initiated biological sample handling log (253KB DOCX)
- Investigator initiated serious adverse event tracking log (246KB DOCX)
- Site staff training log (75KB DOCX)
- Study delegation of responsibilities log (140KB DOCX)
- Investigator initiated reporting template (65KB DOCX)
- RGO investigator initiated sae hrec notification form (46KB DOCX)
This page was last updated 7 May 2025.