27 January, 2026
Author : Dr Vijaykumar Gawali

Topic : ESSENTIAL DOCUMENTS MAINTAINED IN THE INVESTIGATOR SITE FILE (ISF)

1 Definition

The Investigator Site File (ISF) is the official repository of all essential documents that demonstrate compliance with ICH-GCP, the protocol, NDCT Rules 2019, and sponsor requirements.

It must always remain organized, complete, up-to-date, and audit-ready.

2 Categories of Essential Documents in ISF

A. Regulatory & Ethics Documents

• EC approval letters (initial & amendment approvals)
• EC constitution & registration certificate
• EC-approved protocol, ICF, advertisements
• CDSCO approval/NOC (when applicable)
• IB (Investigator’s Brochure) / Product insert

B. Investigator & Staff Qualification

• CVs (signed, updated within 2 years)
• Medical registration certificates
• GCP certificates
• Delegation of Duties Log (updated and signed)
• Site Signature Sheet

C. Study Management Section

• Feasibility form
• SIV/SQV reports
• Training logs
• Protocol deviation log
• Site correspondence file

D. Participant-Related Documents

• Screening &enrollment logs
• Randomization records
• Subject ID list
• Sample shipment tracking documents

E. IP Accountability Section

• IMD/IP shipment invoices
• Temperature logs
• IP receipt, dispensing, return & destruction logs
• IWRS printouts

F. Safety Reporting Documents

• SAE forms (Table-5)
• EC & sponsor SAE acknowledgements
• SUSAR notifications

G. Laboratory/Vendor Documents

• Lab certification (NABL/CAP)
• Reference ranges
• Calibration logs
• Sample handling SOPs

3 Best Practices for ISF Management

• Maintain chronology of document versions.
• File only original, signed documents.
• Maintain cross-referencing index.
• Separate ISF (sponsor file) from Site Trial Master File (site copy).
• Ensure limited and logged access.