Clinical Programs

The Pre-Award process begins when contact is made between the Principal Investigator (PI) and the Pharmaceutical Sponsor (Pharma).

When it is decided that the PI wishes to pursue a relationship with a Pharma, he/she sends an email to OSP which provides the particulars of the relationship (Pharma name, if Investigator-Initiated protocol) and a point of contact. OSP will notify the Associate Dean for Research of the PI's interest.

Before the PI requests a copy of the Protocol from the Pharma, the Pharma typically requests a Non-Disclosure or Confidentiality Agreement (NDA). The PI sends the NDA to OSP for review. If concerns are noted, OSP will coordinate with the PI and the Pharma for a resolution. Once all parties are in agreement with the terms and conditions, OSP will sign the NDA and either return it to the department for their submission or submit it directly to the Pharma, as coordinated with the PI. The Pharma will then release the Protocol to the PI. A fully executed copy of the NDA will be kept in the OSP proposal file.

As the PI is reviewing the Protocol, OSP will review previous agreements with the Pharma and provide feedback to the PI regarding any concerns it may uncover and as available, provide PI with possible solutions in response to those concerns. In an effort to expedite the award review process, OSP may request a preliminary copy of the resulting award agreement for review.

Budget Development

As the PI and the department administrator develop a preliminary budget, OSP is available to assist with estimating personnel costs, fringe benefits, cost share, travel, Facility & Administrative rates/Indirect Costs (F&A/IDC) and other budget issues. EVMS' Budget Form with Cost Match (Form E-2) includes a separate column for cost- shared expenses. The separate Cost Share form has been eliminated. The PI must develop both a Pharma budget and an EVMS internal budget. The PI must ensure that proposed EVMS expenses are covered by the costs of the required Pharma testing costs.

OSP is available to assist with the financial aspects of the budget justification. OSP will coordinate with sub-awardees and be the point of contact between the parties. As the PI refines the budget, the most up-to-date version is provided to OSP. As the proposed budget nears the final stage, it should be submitted to OSP for review and concurrence. When the final budget includes EVMS funded Cost Match, the PI must obtain approval signatures of the Department Chair and the Office of Business Management on the Modular Grant Budget form and submit to OSP. If questions arise as to the suitability of the submission, appropriate EVMS personnel will work with the PI to determine whether the project will be pursued.

Non-Disclosure/Confidentiality Agreements and Material Transfer Agreements

When the PI wishes to include a sub-awardee in the proposal, if a Non-Disclosure Agreement (NDA) or Confidentiality Agreement is requested, the PI sends the Agreement to OSP for review. If concerns are noted, OSP coordinates with the PI and the sub-awardee for a resolution. Once all parties are in agreement with the terms and conditions, OSP signs the NDA and returns it directly to the sub-awardee. OSP provides the sub-awardee a copy of the EVMS standard sub-award agreement and negotiates the terms and conditions with the sub-awardee.

Material Transfer Agreements are reviewed and negotiated by the Technology Transfer Office, who sends copies to OSP for inclusion with the project files.

Additional Pre-Submission Information and Assistance

OSP is available to assist with the preparation of any required Pharma forms (cover page, budget page, justification, etc.). OSP can also retain updated copies of CVs, lists of publications, listings of Current & Pending Support, and Disclosure of Financial Interest Forms for inclusion in Pharma submissions as requested by the PI. These copies are then readily available for inclusion in future submissions.

Proposal Approvals

OSP will initiate the Proposal Approval Form Proposal Approval Form (E-1) Revised 4-4-2013 and submit it to the PI for completion. The signature page of the Proposal Approval Form contains the department chairman's statement regarding the department's maintenance of its clinical responsibility and the total effort of the faculty. Budget approvals must be obtained on the Proposal Approval Form Proposal Approval Form (E-1) Revised 4-4-2013 and the Budget Form with Cost March (Form E-2). All forms must be submitted to OSP before any budget submission to the sponsor. Approvals are required from the PI, any co-investigators, the department chairman for each department involved, and the Associate Dean for Research and OSP.

EVMS Health Services

If EVMS Academic Physicians and Surgeons Health Services Foundation (EVMS Health Services) patients are to be used as study subjects in a proposal, the Clinical Billing Template (Form HS-1) must be submitted with the Proposal Approval Form. Fully signed forms must accompany the proposal submission to OSP. This form is required so that the EVMS Health Services Compliance Office may conduct annual billing audits.

These forms must be accompanied by a complete final copy of the proposal and budget for OSP approvals. The final copy should include both the scientific/technical sections and the administrative/budget sections of the proposal. OSP will review and provide the Institutional signature. OSP will return approved proposals to the department for submission to the Sponsor. The PI is responsible for distribution of internal copies within EVMS. OSP will notify the Associate Dean for Research of the proposal submission.

Notice of Award or Non-funding

When the award is received from the Sponsor, it must be delivered to OSP in Fairfax Hall. The PI should follow up to ensure that any required IRB/IACUC/Compliance approvals are obtained and provide such documentation to OSP. OSP will review the award, compare the administrative and budget information to the proposal submitted, obtain scientific/technical concurrence from PI, manage any necessary negotiations, route for PI and Director of Finance approvals, and return to Sponsor. Distribution of the final agreement and account release information will be sent to Grants Accounting. Once the grant account number is established, the project is ready to start.

If a notice of non-funding is received by the PI, it is forwarded to the Department Chair and OSP for internal tracking purposes.

A grant account may be set up by Grants Accounting ahead of final paperwork being received by use of a Contingent Grant Request form. PIs must contact OSP to determine whether a contingent grant can be established and follow the Financial Services Policy on Contingent Grant Requests.