A New Study Submission Form is required when initiating a new human research project/study that requires IRB approval. This submission form collects the required information and documents needed to begin processing the study and identifying which internal reviews or approvals are needed. Following is a brief outline of the multiple processes triggered by a submission, as applicable:

• New Study Submission packet is reviewed for completeness.
• If applicable, the submission packet is sent to the appropriate Banner Health clinical research program directors for feasibility review and approval.
• A U of A IRB submission may be completed once feasibility approval is received.
• Contract review and negotiation.
• Coverage analysis development and submission to the medical partner for approval.
• Internal proposal routing and approval (for funded studies).
• Budget development and negotiation of budget and payment terms.
• Contract and budget are finalized and fully executed.
• New Study final document packet is compiled and sent to the principal investigator and the study team.
• Study calendar is built within the OnCore clinical trial management system.

The New Study Submission Form should also be used when adding additional Banner sites or facilities to an existing study. Banner feasibility review or approval is required for this type of study amendment.

Once we receive the submission, it will be reviewed for completeness, forwarded to Banner for feasibility review/approval (if applicable) and added to our workflow for appropriate assignments and continued processing.

An Amendment Submission Form is required when making the following changes or updates to an existing (previously approved) study: principal investigator change; contract modification; budget update; protocol amendment; revised consent forms (financial sections, principal investigator); or adding a clinical research data warehouse request. This submission initiates multiple processes needed to incorporate the requested changes/updates including: a feasibility review; an updated coverage analysis; budget and contract negotiations related to the requested revisions; internal proposal routing; and a review of ICF updates.    

Amendments should be submitted to the RAP as soon as possible so updates can be addressed in a timely manner.

An RCR Submission Form should be used for a retrospective data review study involving existing records review, data abstraction and analysis. This submission form also includes a Clinical Research Data Warehouse Request section and must be completed if requesting Cerner CRDW data. If your retrospective data review study involves a prospective component as well, you must utilize the New Study Submission Form.

Summary of documents required for study submission:

Agreements, contracts, incoming subawards, subcontracts, memorandums and letters of understanding involving U of A Health Sciences faculty, staff orstudents that require an institutional signature must be submitted for processing via the RAP using the Contract Submission Form. An editable version of the draft agreement must be included in the submission.

Requests for U of A Health Sciences Contracts to provide a draft template of any of these document types must also use this submission form. If the sponsor or outside party is requesting that U of A Health Sciences Contracts provide the draft agreement, we will need a written request from them and it should be included in the submission.

Once we receive the submission, it will be entered into our workflow for assignment to a contract negotiator. The initial review, which may include a review for missing information, an initial redline returned to the sponsor or medical partner, forwarding to other administrative units, or requests for additional information or approvals from the submitter, is typically completed within two weeks of assignment.

Educational Training Agreements involving UAHS colleges must be submitted for review/negotiation/signature via the RAP using the Educational Agreement Submission Form. This includes affiliation agreements, preceptor agreements, site preceptor agreements, site rotation agreements, incoming training agreements as well as AAMC uniform implementation letters and program letters of agreement if substantive changes are requested.

For data use/transfer agreements or other agreements requiring the transfer of data, the Additional Data Information section of the submission form must be completed. Please make sure to complete all applicable items. Submission forms with missing information will be returned to you for further completion, which may delay processing of your agreement.

The Incoming Materials/Specimens section of the submission form must be completed if receiving materials from an outside party. Please make sure to complete all applicable items. If any needed information is missing, your submission form will be returned to you for further completion, which may delay processing of your agreement.