15  Regulatory Templates & Checklists

15.1 Template: Regulatory Document Tracker (Copy/Paste Table)

Use this as a lightweight tracker for site-level oversight.

Document	Version/Date	Required?	Received Date	Verified By (CRA)	Filed (Site/TMF)	Notes/Actions
Protocol		Yes
ICF		Yes
IRB Approval		Yes
DOA Log		Yes
Training Log		Yes

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15.2 Checklist: Visit-Level Regulatory Review (CRA)

• Current IRB approval present and not expired/lapsed
• Correct ICF version in use; documentation complete
• DOA covers staff performing trial tasks; dates aligned
• Training evidence documented for key systems/processes
• Essential documents filed and reconciled (site/TMF)
• Open regulatory issues tracked with due dates

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15.3 Optional: Issue Log (Regulatory)

Issue	Category	Date Identified	Required Action	Owner	Due Date	Status