Funded agreements with a corporate entity include agreements such a Sponsored Research Agreements (SRAs), Corporate Research Agreements (CRAs), and Clinical Trial Agreements (CTAs). The scope of research activities conducted under these kinds of agreements ranges from basic benchwork to pre-clinical animal work to interventional human subject clinical trials.
Sponsored research is generally considered "cost reimbursable" and should include detailed budgets, including such conditions as:
- a budget related to the project plan. The terms of the agreement may specify allowable or unallowable costs, requirements for prior approvals for particular expenditures, etc.
- a specific period of performance, typically defined with "start" and "stop" dates
- a requirement to return any unexpended funds at the end of the period of performance
- regular financial reporting and audit obligations
Budget negotiation is conducted by the PI/PI's department. The budget should include the University's Facility and Administrative rate (also known as indirect cost rate) for Industrial and Commercial Grants and Contracts applied on a Modified Total Direct Cost (MTDC) basis, unless a waiver of those costs has been approved by the applicable Dean's office (or designee) or the sponsor has a written policy dictating limitations, which should be forwarded to your Clinical and Corporate Contract officer.
Important tips for corporate funded agreements:
- Consistent with federal regulations, all faculty members listed as the PI on a sponsored project must contribute some level of effort to that project to provide necessary supervision/administration. For additional information on Effort Reporting refer to http://www.cfo.pitt.edu/policies/policy/11/11-01-07.html
- Budget negotiators should always begin their negotiation by seeking the F&A rate for Industrial and Commercial Grants and Contracts. Some sponsors will have a policy limiting the F&A rate to a certain maximum percentage, which may be less than the F&A rate for Industrial and Commercial Grants and Contracts. If this is the case, provide such documentation during this step. Please keep in mind that the F&A for clinical trials (interventional in nature) is 25%.
- IDC waivers-needed if Industrial and Commercial Grants and Contracts F&A rate is not contained in the budget and if sponsor has no policy for limiting the indirect costs- in other words, PI/PI's department has elected to accept an F&A rate that is less than the Industrial and Commercial Grants and Contracts F&A rate. In this case, an F&A waiver must be completed.
- If the budget contains both cost-reimbursable payments (invoiced by Research/Cost Accounting) and milestone payments (invoiced by the department), the cost-reimbursable payments and milestone payments should be set-up as separate accounts. The preferred approach is for the larger amount to be set-up as the master account and for the smaller amount to be set-up as a subaccount under the master account. Please submit your stock 0136 form and 0202 form for both the master account and the subaccount during this step if your budget contains both cost-reimbursable and milestone payments.
- The proposed begin date listed on the stock 0136 form and 0202 form cannot precede the effective date of the contract.
- The Clinical and Corporate Contracts Team cannot process Early Account Requests (EARs) in connection with its corporate funded agreements.
Procedure to Initiate Office of Research (OR) Review:
- Principal Investigator (PI) completes the CRA submission form and stock 136 forms.
- Current Conflict of Interest (COI) annual filings for all Investigator(s) and Key Personnel identified by the University of Pittsburgh and sponsor policies and procedures
- If these documents are not completed, approval/submission of the agreement may be delayed.
- Submission packet (as outlined below) should be sent via e-mail to email@example.com. As an alternative, the submission packet can be hand delivered to the Office of Research Suite in B21of the University Club, lower level..
- Upon receipt, the Office of Research will create a file for the CRA in our InfoEd tracking system. The Office of Research will contact the PI and the administrative contact listed on the CRA submission form if any of the essential documentation is missing or incomplete. When all of the essential documentation has been received, the CRA will be given to the assigned contracts officer for review and negotiation.
DOCUMENTS REQUIRED FOR SUBMISSION*
|bolded items represent the essential documentation necessary for OR to initiate review-PI/PI's department is responsible for the submission of additional documentation when available|
*Subject to sponsor's requirements and/or OR procedure changes. Bolded items represent the essential documents necessary for OR to initiate review. Items not in bold are helpful at submission stage, but are not required for submission. These approvals will be required at activation stage, if not available at submission stage.
- Page 2 of the stock 0136 form requires signature by the PI, Department Chair, and Director/Dean. Departments shall obtain the departmental signatures and forward the stock 0136 forms, internal budget, F&A waiver - as designated by your school (if applicable), and any applicable and available compliance approvals to their Dean's office for sign-off, with subsequent forwarding to the Clinical and Corporate Contract team.
Procedure to Submit 0202 Form, and Associated Paperwork to the Office of Research for CRA finalization:
- Once the terms of the CRA have been finalized, the CRA will be sent to the department for PI/departmental approval and PI signature (if required) along with a request for the internal documentation necessary for funded agreements (0202 form, internal budget, applicable compliance approval letters not previously submitted, etc.).
- Upon receipt of requested items, the Clinical and Corporate Contract team will ensure that all required documentation is present and that all required Current Conflict of Interest (COI) annual filings for all all Investigator(s) and Key Personnel identified by the University of Pittsburgh and sponsor policies and procedures are completed. Subsequently, the Clinical and Corporate Contract Team will circulate the finalized CRA for OR signature.
- Once the CRA has been fully executed (signed by all parties), a copy will be sent via PDF to Research/Cost Accounting with a copy to the department administrator so that the account for the project can be activated. Once activated, the research activities covered by this CRA can begin.