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IRB Information

Submitting an IRB?

Here is information to include in your Research Data and Security Plan (RDSP) for the GIM secure server and DOCR REDCap.

GIM Secure Server Document (PDF)

DOCR REDCap Document (PDF)

New Protocol Submission Checklist

The Department of Medicine IRB review process requires that you complete the checklist below for new protocol submissions. The checklist is to be emailed to Monica Harris in the DOM CRU at the time of a new protocol submission. Please email Monica Harris if you have questions. (Last updated: April 2017)

Medicine CRU Checklist

Does your study Require an ICA?

For PI-Initiated Studies that require an Internal Cost Assessment (ICA) form (with the exception of non-sponsored retrospective studies), please contact RoseMarie Howle, Clinical Grants and Contracts Administrator in the DOM RA. She will obtain the necessary information from you to complete this form. You must reach out to RoseMarie to complete this form on your behalf.

Process for Adding Student, Unpaid Volunteers, Visiting Students, and Visiting Scholars to IRB Study Personnel

Please review the IRB Policy
*For DOM CRU approval, email Elaine Dowdy, RPM
**Does not apply for paid non-Duke and paid Duke students (still have to take required trainings and be added to IRB Study Personnel if needed, but no DOM CRU approval required)

Questions about accessing the eIRB system?

All Duke Health researchers must complete the CITI trainings before they can gain access to the eIRB. After you have completed the trainings, your DukeID will automatically be loaded into the eIRB system within 2-3 business days. You should be able to log into the eIRB using your DukeID and password. If you cannot log in, please email eIRB technical support.

VA employees who are key personnel in the Duke eIRB can show their required trainings in order to be included in the Duke eIRB system. You must send copies of your trainings to:

Derrick D. Vines
Training and Communications
Duke Office of Clinical Research (DOCR)
derrick.vines@duke.edu
o: (919) 668-4312

Duke employees can contact Derrick Vines at any time for questions about their training.