The Univsersity of Arizona

Clinical Trials Updates from Research Administration

The Research Administration Office has reached its two-year anniversary of facilitating research across all of UAHS in both Tucson and Phoenix! In that time, our team has grown and we have increased our dedicated clinical research service lines which include:

  1. Payor Coverage Analysis completion for billing compliance.
  2. Developing cost-effective budgets to support multiple aspects of research programs.
  3. Routing and monitoring of contracts (CDAs, CTAs, MTAs, data use and amendments).
  4. Post-award accounting and auditing to assist with invoicing and recouping sponsor-owed funds.

If you are new to UAHS or a seasoned veteran, please contact our office at crc@email.arizona.edu or visit our website with any questions, comments or suggestions. We are here to support you from inception to close out of your research projects.

UAHS RESEARCH ADMINISTRATION UPDATES

Schema Review:

Please contact our office when you are completing the review of the schedule of events to determine what a research-related or routine care cost is. Our staff utilizes the schema review to create a Payor Coverage Analysis (PCA) so that all research projects are in compliance with national Medicare coverage guidelines, national clinical practice guidelines, documentation of funding and billing compliance guidelines.

Our staff is extremely experienced and would be happy to meet with you to complete this very important document correctly and accurately for billing compliance. The finalized PCA will be utilized during the budgeting process. Study delays may occur when the schema review document is not completed accurately.

UAHS Research Intake Form (RIF) Portal:

All new human subject research projects using our medical partner’s (Banner Healthcare/Dignity Healthcare) resources must be entered into the Research Intake Form. Instructions and the form can be found here:  http://research.uahs.arizona.edu/clinical-trials/research-intake-form. If you have questions about the process, email Research Administration at crc@email.arizona.edu or call Julie Johnson at 520-626-7114.

RIF UPDATES:

  • Please be sure to fully complete your application and upload all essential documents prior to submitting your application. Incomplete applications may cause a delay to the study startup process and the study contract will not be routed to the Contract & Research Support Program (CRSP). Please see the attached table for guidance on required essential documents by study type.
  • The option to have UAHS Research Administration submit new projects to the IRB on your behalf has been removed from the RIF. We found that many people did not need our help, as most study teams prefer to have direct communication with the IRB. Please note, if you do need our help and assistance with any regulatory needs, please contact Julie Johnson at 520-626-7114 or crc@email.arizona.edu.
  • The option to have your project submitted to the Radiation Safety Committee for review of the ICF risk language also has been removed. We found that many people did not need our help, as most study teams prefer to have direct communication with the IRB. Please note that if you do need our help and assistance with any regulatory needs, please contact Julie Johnson at 520-626-7114 or crc@email.arizona.edu. Submissions can be emailed directly to rlss-committee-support@email.arizona.edu. Please be sure to include the PI’s name, study sponsor, protocol number and UA departmental PO Box # in your message. Also attach the protocol and ICF(s) for review.
  • The ability to allow multiple users to access a submission to the RIF still is being tested with the IT department. This option will allow multiple users to view, upload documents and complete an application. One caveat, once this ability is able to be fully implemented, it will be available only for new studies entered after its implementation. This option will not be available for older studies and this is due to the application system. We will let you know as soon as this option goes live!
  • You spoke and we listened!! The Study Personnel Tab no longer will be required for feasibility approval. The IT team is in the process of removing this tab from the RIF. The Verification of Training Form (VOTF) / F107 will be utilized going forward to document all study personnel working on the research study. Thank you for your feedback!

“I’ve uploaded my project into the RIF…..Now what?!?!?”

The Research Administration’s role in the study startup process may seem mysterious at times. Below is a brief outline of our process. Please feel free to contact us at any time if you are ever unsure of the status of your research project (crc@email.arizona.edu).

  1. Application submission and uploaded documents are reviewed for completeness.
  2. Project is reviewed for feasibility by Banner Healthcare and UAHS Clinical Research Operations.
  3. Feasibility is approved by both partners.
  4. Contract is sent to CRSP for negotiations.
  5. PCA development and submission to medical partner for approval.
  6. PCA receives approval, budget development begins.
  7. Budget and payment terms are negotiated.
  8. Final budget and payment terms are sent to CRSP for inclusion into contract.
  9. Contract negotiations finalized.
  10. Contract routed for signatures.
  11. Contract finalized and fully executed.
  12. UAHS Research Administration will send a final packet to the PI and study team, including the final contract, budget and PCA.

Christine Gaul, MBA, CRCP, Senior Manager, Clinical Trials

Originally Posted: 
Thursday, August 11, 2016 - 5:45pm