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| Expedited procedure for
preparing a Proposal Routing Form (PRF) for Business and Industry
clinical trials |
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), an expedited procedure for preparing
Proposal Routing Forms (PRFs) for clinical trials has been established.
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 EGMS (http://egms.umn.edu);
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 re-submitting 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 612.624.1033 or help@egms.umn.edu.
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Submission
of initial documents to SPA: prepare PRF and 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.
If obtaining ink signatures
- Answer all the questions on the PRF in EGMS.
- Click in the Do not route electronically checkbox.
- Click the Submit button, which is located beneath the
Comments box on the form.
- Print a portable document format (PDF) copy of the PRF.
- Obtain the PI's signature in the Approvals and Certifications
section of the printed PRF.
- Deliver the signed PRF, the contract, the protocol, and a simple
budget to SPA.
If obtaining electronic signatures
- Answer all the questions on the PRF in EGMS.
- Enter the following Internet IDs in the databoxes under This
PRF's Approval Chain:
- Internet ID of PI; and
- willi478 (Internet ID of Laura Williams - Grant Administrator
in SPA).
- Click the Submit button, which is located beneath the
Comments box of the form.
The PRF routes electronically to the PI for approval.
Once the PI has approved the PRF, it routes electronically to
Laura Williams in SPA. After her review of the contract, she will
return the PRF to the preparer, where it can reside during the
negotiation process.
- 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.
- Deliver the signed PRF, the contract, the protocol, and a simple
budget to SPA.
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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.
Note: only the original preparer
of the PRF can retrieve and update the PRF.
If obtaining ink signatures
- Open the PRF in EGMS and click the Return Request button
to retrieve the PRF for making updates.
- Update the information in the PRF as necessary.
- Add a comment in Question 6 (Mailing Instructions) indicating
that this contract was already submitted to SPA for pre-review.
- Make sure that the Do not route electronically checkbox
is checked.
- Click the Re-Submit Request button.
- Print a PDF copy of the PRF.
- Deliver the PRF, finalized budget, protocol, and contract to
any co-investigators, if applicable, the department head, and
the dean for review and approval.
- Deliver the fully signed PRF, the contract, the protocol, and
the finalized budget to SPA.
If obtaining electronic signatures
- If the PRF has been returned electronically
by Laura Williams after the initial submission process, skip to
step 2.
- If the PRF has not yet been returned,
proceed to step 1.
- Open the PRF in EGMS and click the Return Request button
to retrieve the PRF for making updates.
- Update the information in the PRF as necessary.
- Add a comment in Question 6 (Mailing Instructions) indicating
that this contract was already submitted to SPA for pre-review.
- 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); and
- Internet ID of dean(s).
- Click the Re-Submit Request button.
The PRF routes electronically to the individuals in the approval
chain for approval.
- 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.
- Deliver the fully signed PRF, the contract, the protocol,
and the finalized budget to SPA.
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