Forms & Templates

Downloadable Content Coming Soon

Scientific Review for Research that has not been Peer-Reviewed


Amendment Form for Changes to Study

  

Change in Study Personnel and Contact Information


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