Common elements of a demonstrative projects include sponsor identification
of institutions, non-disclosure agreements (NDA), proposal readiness, and
contracts. In my department, Principal Investigators (PIs) are most often solicited
via 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 is
then reviewed and signed off by a Senior Grant & Contracts Officer (SGCO) in
our Industry Sponsored Research Office (ISRO). After the signatures, the
department receives a protocol, sponsor budget, and contract. For proposal
readiness, I develop the budget based on the assessments in the protocol and
the study coordinators prepare the Institutional Review Board (IRB) application
for submission in parallel. Once the IRB application is submitted, the SGCO negotiates
the contract. In the negotiation, the SGCO works out the IP ownership, proprietary
information, and indemnification issues and then signs the contract as the
Authorized Official.

Common elements of basic or applied research projects
include identification of funding opportunities, proposal guidelines, proposal
development, proposal readiness, certification and assurances, and proposal
submission. In my department, I have a list of key words for each specialty and
I subscribe to various databases for funding opportunities. Once I find a
project of interest I review the proposal guidelines and forward to the appropriate
PIs. In the proposal development stage, the Chairman meets with PIs to
strategize and review their research plans. At that time, I fill in all the
administrative portions of the electronic grant application. In the application
readiness stage, the budget is finalized, I ensure we have all required
components, and all documents are formatted correctly. I also confirm that the
PI has signed all certifications, disclosed any conflicts of interest and
signed all assurances. Before a grant is submitted the SGCO in the Sponsored
Research 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.