Forms & Tools

General IRB Information

Membership Letter
Compliance Letter
IRB Registration Letter
Policies and Procedures (ver. 4-23-2012)

Consent Toolkit
Other Researcher Tools
Paper Forms

Templates

Document Stamping Template and Guidance (All eIRB Consent forms, HIPAA Authorization forms, and Revocation Letters should be on this template. This should not be used for Paper studies.)

For more guidance on VAMC templates, please go to the Atlanta Research & Education Foundation Forms page, where you may find more complete information regarding current template updates and changes. That page can also provide copies of consent documents with the changes tracked, emphasizing portions that have been updated with the latest version.

Consent Instructions and Guidance

Emory IRB Guidance

Federal & Other Guidance

Waiver or Alteration of Consent/HIPAA

Waiver of One or More Elements of Informed Consent Worksheet (ver. 10-1-09)
Waiver of Documentation (signature) Requirement of Informed Consent Worksheet (ver. 10-1-09)
Request for Approval of HIPAA Privacy Rule Waiver/Alteration of Patient Authorization (ver. 7-10-08)

Cancer Studies

Winship Cancer Institute Resources

NOTE: All Winship SOPs have been moved to the
Winship Cancer Institute website

Cancer Therapy Evaluation Program (CTEP) Resources

Clinical Trials

Office of Quality Checklists

Key Points Summary

Reportable Events and Quality Assurance

Emory IRB Guidance and Forms

Reportable Events Guidelines (ver. 9-09-09)
Protocol Deviation Assessment Form (ver. 11-3-11)
Reportable Event Assessment Form (ver. 11-3-11)
Guidance for Serious or Continuing Noncompliance and UPs (ver. 8-31-09)
Reporting Periods Chart for Adverse Events, Protocol Devations, and Unanticipated Problems (ver. 11-14-11)
Root Cause Analysis Worksheet (ver. 11-23-10)
Sample Summary of Events at Continuing Review
Self-Audit Tool (ver. 6-30-11)
Note to File template (ver. 11-3-11)
Designation of Authority Log (ver. 1-11-12)
Fluid & Tissue Sample Log (ver. 11-1-11)
Eligibility Criteria Checklist (ver. 11-3-11)
Enrollment Log (ver. 10-19-11)
Subject Schedule by Enrollment Date (ver. 11-3-11)

VA Guidance and Forms

External Events

New Submission Guidance

Initial Submission Guidance and Documents

Lay Summary Guidance

Protocol Format

Additional Study Documents

Data and Safety Monitoring Boards and Plans Guidance

Drugs and Devices

Investigational Drugs and Devices

Ancillary Review

Vulnerable Populations Worksheets

ResearchMatch

Paper Forms

New Study - N/A. Please note: all new study submissions must go through the eIRB system. This list applies to existing paper studies.

Amendments/Modifications

Modification Request Form

Reportable Events

Continuing Review/Reapproval/Renewal

Please include consent/assent forms, HIPAA authorization forms, and revocation letters (where applicable) that were approved at the last renewal. If you are proposing changes, please submit the version you plan to use in the next approval period.

If your study has a HIPAA authorization form, please be sure to use the most updated form. If your HIPAA authorization form indicates that a revocation letter will be given to study subjects, please include that with your renewal.

Consent/HIPAA Documents
The IRB no longer maintains separate consent/HIPAA documents for paper studies. Please use the documents in the Consent Toolkit section above.

The stamping header should be removed from all consent/HIPAA documents used for paper studies.

VA Documents for Paper Studies

Grady Memorial Hospital

Research Oversight Application

Close-Outs

Close-out Form

Please submit by only one method! How to deliver your paper forms

Email (preferred): irb@emory.edu

In person, by US, express, or campus mail to:

Emory IRB, 1599 Clifton Road, 5
East, Atlanta GA 30322. Mail stop 1599-001-1AV
Fax to (404) 727-1358

Remember: submit just once by only one method. Thank you.