Research Administration Regulatory
Research Administration Portal (RAP)
The Research Administration Portal “RAP” is now available for submissions. Please review the recording of the demo here.
All UAHS submissions involving patients, facilities, services, health records, and/or resources of a clinical provider (e.g., Banner Health/BH) must be submitted to our office here prior to submission to the University of Arizona Institutional Review Board (IRB). For new studies, the RAP 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.
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 RAP forms.
For new studies, the RAP initiates multiple processes including Banner feasibility review, coverage analysis development, budget & contract negotiations, financial review of ICF, and entering the study into the OnCore (CTMS), as applicable.
New to RAP?
No need to struggle through the process! We have experienced experts to help, please contact our office by email or schedule a consultation on MS Bookings, and we will guide you through the process.
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
Yes, upon request UAHS Research Administration is happy to provide individual training and support with the RAP. Please email CRC@arizona.edu to schedule a training.
Funding Categories | ||||
Externally Funded | Internally Funded | Grants | Retrospective | |
| Contract Template (WORD draft) | X | |||
| Budget Template (EXCEL or WORD draft) | X | |||
| Protocol | X | X | X | |
| Informed Consent Form(s) or relevant IRB Appendix | X | X | X | |
| Schedule of Events/Study Schema | X | X | X | |
| IRB Form: IRB Protocol | X | X | X | X |
| Draft eIRB Application | X | X | X | X |
Yes, a submission form for Amendments is now available for the following documents:
- Protocol Amendments
- Contract (CTA) Agreements
- Budget Amendments
- Revised Consent Forms
If your RAP Amendment application involves a CTA Amendment, the associated contracting amendment documents should be submitted.
If a Protocol Amendment affects the Schedule of Events (SOE), a revised SOE will need to be uploaded with the amedment application, so that the Coverage Analysis (CA) and Budget can be reviewed and updated for OnCore study calendar updates and billing compliance. Amendments should be submitted to the RAP as soon as possible so updates can be addressed concurrently with IRB review.
Yes, the UAHS Research Administration Intake Team will route the agreement to the contract negotiator after feasibility approval. Contact CRC@arizona.edu with questions about the clinical trial agreement process.
Yes, if you are using Banner Health resources (including facilities, data, or employees), the RAP submission must be completed.
Yes, you should submit directly to these committees (links are provided above).
Studies that require the use of Banner resources, must receive their notice of feasibility approval prior to submission to the IRB. Funded studies must wait until the coverage analysis is complete and the project has been routed and approved through sponsored projects for submission to the IRB. This deferment in UA eIRB submission will eliminate duplicate COI disclosure requests and streamline consent form revisions.
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 (CRC@arizona.edu).
- Application submission reviewed for completeness and sent to Banner Health Clinical Research Program Directors (CRPD) for feasibility approval.
- Project is reviewed and approved for feasibility by Clinical Research Program Directors (CRPDs).
- Your non-funded 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, internal proposal is routed, budget development begins.
- Internal proposal is approved by sponsored projects; funded projects can now be submitted to the IRB with a copy of your feasibility approval email.
- Budget and payment terms are negotiated.
- Final budget & payment terms are sent to UAHS Contracts for inclusion into contract.
- Contract negotiations finalized.
- Contract, inclusive of budget and payment terms, is 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. UAHS Research Administration Oncore team will build the study calendar into the OnCore CTMS (Clinical Trial Management System) and notify study team when calendar is active.
Please contact our office at CRC@arizona.edu 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.