Business & Industry Clinical Trials Expedited PRF

To reduce the time needed to process business and industry clinical trial agreements and still meet the business needs of both the home colleges and Sponsored Projects Administration (SPA), we have established an expedited procedure for preparing Proposal Routing Forms (PRFs) for clinical trials.

The PRF and supporting documents are submitted to SPA in two stages. Initially, the PRF is prepared but signed only by the principal investigator (PI), then delivered to SPA with the contract, simple budget, and protocol.

Then, after negotiations on the protocol are completed and the budget is finalized, the PRF is retrieved and updated, submitted to the department and college for review and approval, and then delivered to SPA with the contract, finalized budget, and protocol for final processing.

PRFs are prepared in the Electronic Grants Management System (EGMS); PRF signatures are collected using either an ink or electronic process. A summary of the steps for preparing a PRF and collecting its initial signatures and for updating and resubmitting the PRF are listed below. To obtain assistance with all of the steps needed for preparing a PRF in EGMS, contact the EGMS helpline at (612) 624-1600 or help@egms.umn.edu.

Submission of Initial Documents to SPA: Prepare PRF & Obtain PI Signature

Initially, a PRF is prepared but signed only by the principal investigator (PI), then delivered to SPA with the contract, budget, and protocol. 

Obtaining Ink Signatures

1. Answer all the questions on the PRF in EGMS.
2. Click in the "Do not route electronically" checkbox.
3. Click the "Submit" button, which is located beneath the "Comments" box on the form.
4. Print a portable document format (PDF) copy of the PRF.
5. Obtain the PI's signature in the "Approvals and Certifications" section of the printed PRF.
6. Deliver the signed PRF, the contract, the protocol, and a simple budget to SPA at proposal@umn.edu.

Obtaining Electronic Signatures

1. Answer all the questions on the PRF in EGMS.
2. Enter the following Internet IDs in the databoxes under "This PRF's Approval Chain":
   • Internet ID of PI
   • Internet ID of a department approver
3. Click the "Submit" button, which is located beneath the "Comments" box of the form.
4. The PRF routes electronically to the PI for approval.
5. After the PI has approved the PRF, print a PDF copy. The PDF will display the PI's Internet ID in the "Approvals and Certifications" section of the PRF.
6. Deliver the signed PRF, the contract, the protocol, and a simple budget to SPA at proposal@umn.edu. SPA will review the documents and the negotiation process will begin.

Submission of Documents after Negotiations are Completed: Update PRF and Collect Administrative Signatures

After negotiations on the protocol are completed and the budget is finalized, the PRF is retrieved and updated, submitted to the department and college for review and approval, then delivered to SPA with the contract, budget, and protocol for final processing. Only the original preparer of the PRF can retrieve and update the PRF.

Obtaining Ink Signatures

1. Open the PRF in EGMS and click the "Return Request" button to retrieve the PRF for making updates.
2. Update the information in the PRF as necessary (i.e., budget information, IRB number and approval date, if applicable, etc.).
3. Add a comment in Question 6 (Mailing Instructions) indicating that this contract was already submitted to SPA for pre-review.
4. Make sure that the "Do not route electronically" checkbox is checked.
5. Click the "Re-Submit Request" button.
6. Print a PDF copy of the PRF.
7. Deliver the PRF, finalized budget, protocol, and contract to any co-investigators, if applicable, the department head, and the dean for review and approval.
8. Deliver the fully signed PRF, the contract, the protocol, and the finalized budget to SPA at proposal@umn.edu.

Obtaining Electronic Signatures

If the PRF has been returned electronically after the initial submission process, skip to step 2. If the PRF has not yet been returned, proceed to step 1.

1. Open the PRF in EGMS and click the "Return Request" button to retrieve the PRF for making updates.
2. Update the information in the PRF as necessary.
3. Add a comment in "Question 6 (Mailing Instructions)" indicating that this contract was already submitted to SPA for pre-review.
4. Enter the following Internet IDs in the databoxes under "This PRF's Approval Chain":
   • Internet ID of PI
   • Internet ID of co-investigator(s), if applicable
   • Internet ID of department head(s)
   • Internet ID of dean(s)
5. Click the "Re-Submit Request" button.
6. The PRF routes electronically to the individuals in the approval chain for approval.
7. After all the approvers have electronically signed the PRF, print a PDF copy of the PRF. The PDF will display the internet IDs of the approvers in the "Approvals and Certifications" section of the PRF.
8. Deliver the fully signed PRF, the contract, the protocol, and the finalized budget to SPA at proposal@umn.edu.