Note to file examples: Example 1 (DOC) Example 2 (DOC) Example 3 (DOC)
Meeting Communication Record
Download the Meeting Communication Record Template (DOC).
Medical History
Download the Medical History Form (DOC).
IRB-FDA Tracking
Download the IRB-FDA Tracking Form (DOC).
ICH-GCP E6(R2) Guidelines
Essential Documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.
End of Study Checklist
Download the End of Study Checklist (DOC).
Eligibility Checklist (Inclusion/Exclusion Criteria)
Download the: Eligibility (I-E) Checklist (DOC) Multi-Part Eligibility Checklist with Interview Selection (DOC)
Protocol Deviation Form
Download the Protocol Deviation Form (DOC).
Deviation Log
Download the Protocol and Deviation Log (PDF).
Demographics CRF
Download the Demographics CRF Demographics and Contact Form (DOC) Including Health History (DOC) Without Health History (DOC)