Common elements of a demonstrative projects include sponsor identificationof institutions, non-disclosure agreements (NDA), proposal readiness, andcontracts. In my department, Principal Investigators (PIs) are most often solicitedvia email and at various conferences to participate in industry clinical trials.Once a PI shows interest in a project, the sponsor will send a NDA.
The NDA isthen reviewed and signed off by a Senior Grant & Contracts Officer (SGCO) inour Industry Sponsored Research Office (ISRO). After the signatures, thedepartment receives a protocol, sponsor budget, and contract. For proposalreadiness, I develop the budget based on the assessments in the protocol andthe study coordinators prepare the Institutional Review Board (IRB) applicationfor submission in parallel.
Once the IRB application is submitted, the SGCO negotiatesthe contract. In the negotiation, the SGCO works out the IP ownership, proprietaryinformation, and indemnification issues and then signs the contract as theAuthorized Official.Common elements of basic or applied research projectsinclude identification of funding opportunities, proposal guidelines, proposaldevelopment, proposal readiness, certification and assurances, and proposalsubmission.
In my department, I have a list of key words for each specialty andI subscribe to various databases for funding opportunities. Once I find aproject of interest I review the proposal guidelines and forward to the appropriatePIs. In the proposal development stage, the Chairman meets with PIs tostrategize and review their research plans. At that time, I fill in all theadministrative portions of the electronic grant application. In the applicationreadiness stage, the budget is finalized, I ensure we have all requiredcomponents, and all documents are formatted correctly. I also confirm that thePI has signed all certifications, disclosed any conflicts of interest andsigned all assurances.
Before a grant is submitted the SGCO in the SponsoredResearch Funds &Administration (SRFA) office reviews the PI’s compliance,assurances, certifications, and the grant application for accuracy. Once approved,the SGCO submits the application as the Authorized Official.