DOCUMENTS IN eRPM
Unfunded Agreement (UFA)
An Unfunded Agreement, or UFA, is any research-related contract that does not have incoming dollars attached to it. Medical School faculty often participate in activities or collaborations that do not involve payments from sponsors. Before these unfunded research activities can be carried out, written contracts that document expectations and responsibilities are put into place.
For incoming agreements, you are encouraged to talk with your sponsor about the use of U-M’s templates whenever possible. If sponsors are able to sign an unedited version of the agreement, campus is able to execute quickly.
UFAs are prepared in and electronically routed through the eResearch Proposal Management (eRPM) system. While some UFAs route directly to the appropriate central office (the Office of Research and Sponsored Projects (ORSP) or the U-M Innovation Partnerships (formerly Office of Technology Transfer) for processing, others will require departmental approval for the use of space, security requirements, faculty effort, etc. Each Medical School department is responsible for approving their own UFAs as needed. The departments’ business processes may vary, so please contact your Department Contact with questions regarding the approval process.
There are four types of UFAs available to choose from when preparing a new UFA in eRPM. They are:
- Data Use Agreement (DUA)
- Material Transfer Agreement (MTA)
- Non-Disclosure Agreement (NDA)
- “Other” Agreements
Detailed descriptions of each of these agreements are available through the ORSP website on UFAs.
Currently, ORSP handles most NDAs, DUAs, and “Other”; while OTT handles most MTAs. The eRPM system will automatically assign to the central office based on your completed forms. But if you have questions regarding the templates or the system, please contact the Grants Office or central office most likely to handle.
Guidance and Tools
Clinical Trial Routing Form (CTRF)
Medical School Required Use of the CTRF in eRPM
The Clinical Trial Routing Form (CTRF) allows study agreement contract negotiations to proceed in parallel with budget negotiations and regulatory approval.
We have had success in the use of the CTRF. In the Pilot, we had the option of sending draft industry-sponsored clinical trial contract agreements to ORSP to begin language review and negotiations prior to receiving the PAF. However, we also recognized in the Pilot, “noise” was created by last minute agreements that arrived at ORSP with the PAF, disrupting work flow. In an effort to continue streamlining the clinical trial process, more appropriately queue work, and capture performance metrics, the Medical School and ORSP are mandating the use of the CTRF for certain projects.
Effective 7/1/2013, the Clinical Trial Routing Form (CTRF) will be REQUIRED for all activity in 31200, Clinical Trial Site Activity. This expands the use from solely industry to any sponsor (federal, non-profit, AND industry).
Additionally, the CTRF should also continue to be used for investigator-initiated industry-sponsored clinical trials (in the Research class codes) when there is a draft agreement prior to a PAF routing.
We anticipate there may be some instances when you file a CTRF and then immediately route a PAF. We are aware and would like to observe the impact of these instances through data collection and direct feedback. We will be analyzing the relative benefit of the CTRF, its impact on both the time to execute study agreements and overall timeline to activate clinical trials.
We will be monitoring utilization of the CTRF and following up with further education for those units that do not use the form. We are interested in receiving feedback on any issues or potential barriers units identify.
If a project team has questions on the use the CTRF for their 31200 Clinical Trial Site Activity project, please call Heather Offhaus in Grant Services & Analysis to discuss (734-763-4272).
See Using the Clinical Trial Routing Form (CTRF) for specific information on how to use them.
Proposal Approval Form (PAF)
Each proposed or received grant or contract must route for approval. It is expected that this takes place prior to proposal being sent to the sponsor. The Proposal Approval Form (PAF) serves as the electronic record of the proposal. The PAF, which is part of the eResearch Proposal Management (eRPM) system, electronically routes the application through the appropriate University channels for approval. The PAF is a summary of information about the project along with the attachment of the actual application that is used for internal review and approval through post-award data management.
eRPM Proposal Approval Form online learning courses and other training materials are available at: http://www.umich.edu/~eresinfo/erpm/training.html.
Pre-Proposal (PRE) vs. Proposal Approval Form (PAF)
A PRE must be completed and routed in eRPM only if the sponsor requests:
- an “approval” or “signature” from an “authorized” University official,
- or physical or electronic submission by ORSP.
- See also ORSP's policy on PREs.
Caveats:
- If the Pre-Proposal is a Limited Submission, units must work with UMOR or Medical School Office of Research (see U-M Medical School and the U-M Office of Research (UMOR) for appropriate endorsement prior to submission.
- If categorical budgets and/or other resource or commitments are represented (including cost sharing commitments, third party or effort commitments), the information must follow standard Med School/UM policy of representation. Regardless of how information has been represented (e.g., use of DHHS salary cap, incorrect IDC rate or calculation), the full proposal will be required to include the appropriate information and no exceptions will be made on the final / official proposal based on pre-proposal information.
Note: If you begin a PRE mistakenly, it cannot be converted in the eRPM system to a regular PAF; care should be taken to choose the correct vehicle.
Additional information is provided by the Office of Research & Sponsored Projects (ORSP). See the ORSP Standard Operating Procedure for exact definitions and contact the Grants Office at msgrants@umich.edu or 734-763-4272 if you are in need of help interpreting or direction.
COMMUNICATING IN eRPM
Leaving Comments in eRPM
This best practice reminds eRPM users of some simple etiquette to be used when leaving comments in eRPM either through the “Post a Comment” activity or when submitting changes.
The recommendation is that when leaving comments please be concise but through so that anyone looking at the PAF will understand what was done and why.
With this in mind, please ensure that your comments are meaningful and substantial. Simply stating “change made per email from Grants” does not tell any other approvers what changes were made, and/or if those changes impact them. Additionally, the project team doesn’t have a clear record in the system of what was changed and why.
When making comments in eRPM please remember that everyone that has access to view the PAF will be able to see your comment. Please also know that in the case of performing the activity to “Submit Changes”, acknowledgement requests will be generated. Acknowledgement requests are sent to all units that have approved the PAF prior to the change being submitted. The acknowledgement requests direct those approvers to confirm the PAF in its new state. Individuals receiving these email Acknowledge notices rely heavily on the notes included (taken from the Submit Changes activity) in order to understand changes made to the project
Changes After Routing in eRPM
Occasionally, the project team/PI has a change that needs to take place after a proposal’s administrative shell has been routed in eRPM. The change could be initiated by the Project Team or in result of questions from other Unit Reviewers. The changes may not have impact on other participating units; however, good communication is required in such a large system of approvals. As a result, this best practice provides guidelines to follow when changes are made to the administrative shell after it has been routed.
Changes During A Unit Review
If the proposal is sitting in the Dean’s Office awaiting review and changes need to be made, please call the Grants Office, 3-4272, to let us know BEFORE making any changes.
If a change by the Project Team to a proposal’s administrative shell is needed while a unit review is underway, immediate communication to reviewers is necessary in order to help them understand any impact of the change. In these instances, the reviewer may need to stop their review until the changes are complete. Conversely, if the changes do not impact the unit, and it is clearly communicated, the reviewer could choose to continue their individual review while the changes are occurring.
When there is a change during review, please call, email or “Post a Comment” in eRPM to the other participating units so they are aware of the changes being made and if it impacts their unit.
Changes After A Unit Approval
As a reminder, changes should not be made to the administrative shell following Medical School Grants Office Approval. If a change becomes necessary, even if requested by ORSP, please call us at 3-4272 or email msgrants@umich.edu, BEFORE making any changes.
When a proposal’s administrative shell is changed after a participating unit has approved, the unit will receive an “Acknowledge” Activity. Often times there is no detailed description of the changes noted that would allow the units to know what was changed and if the changes impact them. There is a need to improve the communication in order to inform units of impact (or non-impact) to their unit.
As a result, please call or email the impacted units to inform them of the change that was made.
Canceling a PAF
eResearch Proposal Management (eRPM) offers an action called ‘Project Team Cancel PAF.’ Both the PI and the Primary Research Administrator (PRA) have the ability to cancel a PAF. When this action is used the specific PAF will no longer be able to be submitted to the sponsor.
Within the Medical School, it becomes necessary to cancel a PAF when the PI decides not to submit a proposal yet the PAF has already been approved by participating units. The School will require this procedure until another solution is available in the eRPM system.
There are several reasons to cancel:
- There is no way for units to effectively suspend their approval and re-review after changes are made in the next submission iteration. The proposal would stay in active routing states which would cause issues determining when a proposal is ready to move forward with accurate information.
- In the case of NIH submissions using the 424 attached to the PAF, NIH advises to re-download forms in case of changes. This must be done on a new PAF.
- In the case of other sponsors, while the forms may not change, a new download of the forms (with changes) will inevitably be needed.
The roles that may cancel a PAF are the PI, PRA, and PR. A PAF may be cancelled by the PI or PRA while in one of the following states: Proposal Preparation, Unit Review, Unit Review – Project Team Making Changes and Reviewer Making Changes. Once the PAF has reached ORSP, the project team must request the Cancel from the PR.
After a PAF is cancelled it can be found on the PI & Project Team’s “Cancelled” tab in the “My Home” workspace.
If the Project Team chooses to submit the project in a future cycle the cancelled PAF may be cloned. ALL fields filled out carry over to the newly created PAF, except the attachments.
Steps for the Project Team to Cancel:
- Click the “Project Team Cancel PAF” Activity. This can be found in the gray, left-hand side bar under the Activities header.
- Enter the reason that the PAF is being cancelled and the person that requested the cancellation (if applicable) in the comments text box and then click “OK.”
- Notify ORSP/Dean's Office.