ICH-GCP Compliance Verification Checklist Form

All site staff have completed ICH-GCP training and documentation is up to date.

Essential regulatory documents are maintained and readily accessible.

Current clinical trial protocol and amendments are implemented and available.

Delegation of duties log is complete and up to date.

Investigational product is stored, handled, and documented according to protocol.

Subject informed consent process is documented and follows protocol (do not collect consent here).

Adverse event and serious adverse event reporting procedures are in place and followed.

Data entry and source documentation are accurate, complete, and contemporaneous.

Monitoring visits are conducted and findings are documented and addressed.

Records are retained and archived according to ICH-GCP and local requirements.