35  Safety Templates & Checklists

35.1 Safety Oversight Checklist (CRA)

• AE/SAE listings reviewed
• SAEs reported within required timelines
• Source documentation present
• Follow-up obtained for ongoing events
• Safety correspondence filed
• TMF reconciled as required

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35.2 Safety Issue Log (Template)

Event ID	Issue	Date Identified	Required Action	Owner	Due Date	Status

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35.3 Follow-Up Request Template

Date:
Study / Site:

35.3.1 Issue

Describe missing or inconsistent safety information.

35.3.2 Required Action

Specify documentation or clarification needed.

35.3.3 Due Date

Specify timeline per protocol/safety plan.