Forms & Templates

Downloadable Content Coming Soon

Scientific Review for Research that has not been Peer-Reviewed

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Amendment Form for Changes to Study

Change in Study Personnel and Contact Information

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Closure Form

Final Study Status Report (FSSR) Electronic Submission

Consent Templates

• Template for Clinical Trials Consent

• Template for Non-Clinical Trial Informed Consent

• Template for Focus Group or Individual Interview Consent

• Basic Elements of Consent Disclosure Statements for Survey Research 

• Informed Consent Template for Permission to the Re-contacted for Future Research

Adverse Event Reporting and Safety Data Forms

• Local Adverse Event Unanticipated Problems Form and Instructions

• Local Adverse Event Unanticipated Problems Follow-Up Form

• External (Non-Local) Adverse Event Form and Instructions

• Updated Safety Information Form and Instructions

• Periodic Safety Update Form and Instructions

Protocol Deviations Reports (including for Privacy Breaches)

• Major Protocol Deviation Form

• Minor Protocol Deviation Form

Annual Review

Study Closure and Termination

Request for Preliminary Access (RPA) to Grant Funding