Download the Medical History Form (DOC).
Author: Catherine
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)
Delegation of Authority Log
Download the delegation of authority log.
Daily Temperature Log
Download the daily temperature log.