All UAHS submissions involving patients, facilities, services, health records, and/or resources of a clinical provider (e.g., Banner Health) must be submitted to our office here prior to submission to the University of Arizona Institutional Review Board (IRB). For new studies, the RIA initiates multiple processes including Banner feasibility review, coverage analysis development, budget & contract negotiations, financial review of ICF, and entering the study into the OnCore clinical trial management system (CTMS), as applicable.
Does my study require a RIA submission? If your study has a UAHS PI or requires the use of Banner resources, new and amended studies must be submitted to Research Administration using the RIA forms.
I’m not using Banner resources, why do I need to submit a RIA? For new studies, the RIA initiates multiple processes including Banner feasibility review, coverage analysis development, budget & contract negotiations, financial review of ICF, and entering the study into the OnCore clinical trial management system (CTMS), as applicable.
UPDATE TO THE NEW CLINICAL TRIALS SUBMISSION - EFFECTIVE 9/14/2021
Funded studies will receive notice of feasibility approval and an approval to move forward with UA IRB submission after the coverage analysis is complete. This deferment in UA eIRB submission will eliminate duplicate COI disclosure requests and streamline consent form revisions. The change will not alter the UAHS contract and budget timelines, so the overall time for study start-up should remain the same.
New to RIA submissions? No need to struggle through the process! We have experienced experts, please contact our office by email or schedule a consultation on Bookings, and we will guide you through the process.
The Schedule of Events and Clinical Research Contract processes are included in this form.
For information regarding additional approvals that may be required prior to IRB submission, please review the links below:
Banner Health Research Feasibility Review
Required for all protocols that involve research being conducted at a BH site, BH services, patients with a treating relationship with BH (past/present), data or specimen collection, etc.
UA Radiation Safety Review Committee
All protocols that involve exposing individuals to ionizing radiation for research purposes require UA Radiation Safety Committee review. Examples include: x-ray, PET, CT, DXA, nuclear medicine, and radiation therapy (e.g., radiation oncology studies).
UA Institutional Biosafety Review Committee
See the NIH Guidelines for research that requires UA Institutional Biosafety Committee review.
UA Human Subjects Protection Program (HSPP)
Our team can help with completion of the required forms for the IRB.
Frequently Asked Questions
Is there training provided for the RIA? Who should attend?
Yes, upon request UAHS Research Administration is happy to provide individual training and support with the RIA. Please email CRC@email.arizona.edu to schedule a training.
What documents are required for your project submission?
Will Contract amendments be submitted to the RIA?
Yes, a new Research Intake Application for Amendments is now available for the following documents:
- Protocol Amendments
- Contract (CTA) Agreements
- Budget Amendments
- Revised Consent Forms
If your RIA Amendment application involves a CTA Amendment, UAHS Contracting will receive associated contracting amendment documents.
If a Protocol Amendment affects the Schedule of Events (SOE), a revised SOE will also need to emailed to the RIA submission email , so that the Coverage Analysis (CA) and Budget can be reviewed and updated for billing compliance.
Can I submit my Clinical Trial Agreement (CTA) to the RIA?
Yes, UAHS Research Administration will route the agreement to the UAHS contracts group after feasibility approval and monitor CTA negotiations. Contact CRC@email.arizona.edu with questions about the clinical trial agreement process.
I work in another College outside UAHS. Is the RIA for me?
Yes, the RIA must be completed for all research utilizing any data, patients, employees, services, and/or other resources of a clinical provider including Banner Health.
Does the research team submit directly to the IRB, Institutional Biosafety Review Committee, and/or Radiation Safety Review Committee?
Yes, you should submit directly to these committees (links are provided above).
What happens once my project is submitted to the RIA?
Below is a brief outline the UAHS process. Please feel free to contact us at any time if you are ever have any questions regarding your research project (firstname.lastname@example.org).
- Application submission through email are reviewed for completeness.
- Project is reviewed for feasibility by Banner Healthcare and UAHS Clinical Research Operations
- Feasibility is approved by both partners.
- Your project can now be submitted to the IRB with a copy of your feasibility approval email.
- Contract is sent to UAHS Contracts for negotiations.
- Coverage Analysis (CA) development and submission to medical partner for approval.
- CA receives approval, budget development begins.
- Budget and payment terms are negotiated.
- Final budget & payment terms are sent to UAHS Contracts for inclusion into contract.
- Contract negotiations finalized.
- Contract routed for signatures.
- Contract finalized and fully executed.
- UAHS Research Administration will send a final packet to the PI & study team including the final contract, budget, and CA. Banner Finance will build the study calendar into the Click CTMS (Clinical Trial Management System) and notify study team when calendar is active.
How do we track the progress of our research project?
Please contact our office at email@example.com for updates about submissions pending feasibility approval.
After feasibility review has been approved, project status can be obtained by reviewing the Contract Status Report. This report is updated every Monday and requires a NetID login to access.
Contact the IRB at VPR-IRB@arizona.edu directly with any questions regarding your IRB submission and the approval status, as they can provide the most complete and accurate information.