Forms
The Research Integrity Office offers various forms and templates to assist the Emory research community.
Expanded Access or Compassionate Use
- Checklist for Individual Patient Expanded Access non-Emergency IND Submission (DOC)
- IND Expanded Access Withdrawal: Expanded Access IND withdrawal request template (DOCX)
- For specific information on procedures at Emory, see the FDA page on the IRB website.
FDA Inspections
Forms for both Drug and Device Studies
- S-I IND/IDE Regulatory Documentation Checklist Item Descriptions (DOCX)
- Emory Sponsor IND/IDE Multi-site Regulatory Documentation Checklist
Device Studies
- Investigator Agreement Template (DOCX)
- Sample SOPs (DOCX)
- Progress Report Template (DOC)
- Emory Sponsor Regulatory IDE Checklist (DOCX)
- Study start-up: Checklist (DOCX)
- SOP development: Sample SOPs (DOCX)
IDE Transfers
- IDE Transfer Checklist (DOCX)
- IDE Transfer Request Template New S-I (DOCX)
- IDE Transfer Request Template Transferring S-I (DOCX)
Drug Studies
- Emory Sponsor Regulatory IND Checklist (DOCX)
- IND Application Submission Checklist (DOCX)
- IND: Amendment Submission for New Protocol Checklist (DOC)
- IND Amendment Submission cover letter template (DOCX)
- Study start-up: Checklist (DOCX)
- SOP development: Sample SOPs (DOCX)
- Annual Reports: Annual report template (DOCX)
- Safety Reports: Adverse Event Assessment Form (DOCX)
- IND Withdrawal: IND withdrawal request template (DOCX)
IND Transfers
- IND transfer information and templates
- IND Transfer Checklist (DOCX)
- IND Transfer Request Template New S-I (DOCX)
- IND Transfer Request Template Transferring S-I (DOCX)
Self Monitoring
REDCap Self Assessment | Instructions (emory.edu)
Additional Forms
- Clinical trial form templates
- Financial disclosure certification form (DOCX) (see also Frequently Asked Questions for information on who needs to complete financial disclosure forms)
- Investigator Checklist for the use of Schedule (DOCX)1 Controlled Substances
- REMS Checklist
If you have any questions or would like to discuss topics related to FDA-regulated studies, please contact us at researchcompliance@emory.edu.