Download the Regulatory Document Tracking Form (PDF).
Subgrouping: Source Documents
Regulatory Binder Templates
Templates for the Regulatory Binder Outside Cover (DOC) Title Page (PDF) Spine Insert (PDF)
Physical Exam Form Examples
Download Physical Exam Form Examples Example 1 (DOC) Example 2 (DOC)
Note to File Examples
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).
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).