Forms

The Office of Research Integrity and Compliance 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

• FDA/Site Inspection Guide (DOCX)
• FDA/Site Inspection Checklist (DOCX)

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

• S-I IDE Responsibilities Checklist (DOCX)
• S-I IDE Responsibilities Checklist Continuing Review Update (DOC)
• S-I IDE Responsibilities Checklist Multi-site Trials (DOCX)
• 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)
• S-I IND Responsibilities Checklist (DOCX)
• S-I IND Responsibilities Checklist Continuing Review Update (DOC)
• S-I IND Responsibilities Checklist Multi-site Trials (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 ORIC Emory.