Clinical Research Toolbox

Hatton Documents

Documenting Consent Notes

How to Set Up a Digital Signature for Signing Forms

HIPAA Definitions and 18 Identifiers

Initial Submission Forms

New Study Submission Form

Non-Interventional & Non-Sponsored New Study Submission Form

Key Study Personnel for New Study Submission

Sub-Study Form

HUD/HDE Checklist

Genomic Sub-Study Checklist

Researcher Conflict of Interest Questionnaire

Conflict of Interest Policy

Protocol Template

Informed Consent and Authorization Template

Waiver or Alteration of Informed Consent

Waiver of Documentation of Informed Consent

Waiver or Alteration of Authorization Form/Partial Waiver for Recruitment

Facility Impact Form

Pharmacy Form

IRB Ongoing Review and Safety Forms

Continuing Review/Re-Approval/Final Report Form

Continuing Review/Re-Approval/Final Report Form Checklist

Protocol Deviation Log

Modification Form

Staff Change Form

Key Study Personnel - Appendix A

Change in PI - Responsibility List - Appendix B

Unanticipated Problems Submission Form

IND/IDE Safety Submission Form

Protocol Deviation/Non-Compliance Form

Safety Submission Form

Final Study Closure Submission Form