Engaging ORAQ for Review or Support
If I was already working with ORAQ on my project before the changes to institutional regulatory support, do I need to complete the RA Service Request Form for the project?
No. The form does not need to be completed if ORAQ was already assisting with the project prior to January 1, 2022.
What should I expect after I submit the RA Service Request Form?
Following the submission of a service request form, you will be contacted directly by a Regulatory Affairs Scientist who will assist with the request. Depending on the type of request, the Scientist may schedule a time to meet with you or may request additional information/documents for review.
ORAQ aims to review and initially respond to all service requests within two business days. For time-sensitive requests, we ask that you email our general inbox at ORAQ@duke.edu following the submission of a service request form.
If I need to make changes to the information after submission of the RA Service Request Form, how do I inform ORAQ?
If your request has been assigned to a Regulatory Affairs Scientist, you may contact that individual directly to update information. If your request has not yet been assigned, please email our general inbox at ORAQ@duke.edu.
Whom should I contact with additional questions?
Additional questions can be sent to our general inbox at ORAQ@duke.edu. Alternatively, questions can be directed to Regulatory Affairs leadership at email@example.com or firstname.lastname@example.org.
If there are two individuals co-leading the project (two sponsors), how do I complete this field?
In situations where there is more than one faculty member contributing to a project, the individual that would like to assume regulatory responsibility for the project should be listed as the sponsor. This individual will be the one leading interactions with ORAQ and serving as the sponsor of any future regulatory applications (e.g., IND, IDE).
If there is more than one department or institute affiliated with the project, how do I choose the appropriate department?
If there is more than one department affiliated with a project, faculty collaborators will need to discuss and choose a principal department.
What should I do if the department or institute affiliated with the project is not included on the list?
If you do not see the department or institute on the provided lists, please contact our office at ORAQ@duke.edu to discuss the project affiliation.
Service Request Questions:
If I already submitted an RA Service Request Form for my project but now need assistance with a different service for the same project, do I need to submit the ORAQ Service Request Form again (e.g., previously requested an Initial Consultation and now need assistance with Document Preparation)?
No. ORAQ only requires the submission of one RA Service Request Form per project. Once your project has been assigned to a Regulatory Affairs Scientist, you may continue to request assistance with that same project by contacting the assigned Scientist and informing them of your needs.
A new RA Service Request Form should be completed for each unique project. Projects are tracked according to investigational product and indication and are typically associated with one regulatory application (e.g., IND). If you begin investigating a new product or indication, resulting in the need to submit a separate regulatory application to the FDA, this will be tracked as a new project and a separate RA Service Request Form should be completed.
ORAQ Team Member Questions:
If I have previously worked with more than one ORAQ team member, can I select more than one name?
No, you cannot select more than one ORAQ team member. If you have worked directly with an ORAQ team member on the specific project for which you are requesting support, please select that individual from the list. If you haven’t yet worked with an ORAQ team member on the specific project, then no one should be selected from the list, and an RA Scientist will be assigned to your project.. If you previously worked with an ORAQ team member on a different project, we will try to keep your ORAQ team member consistent, if possible.