- Invited applicants are to follow the RFP guidelines for submitting the full proposal, which includes:
- Specific aims
- Background and significance
- Brief overview of approach
- Study timeline
- Potential for substantial extramural funding
- Budget and justification
- NIH Biosketches
- Invited applicants are also encouraged to participate in the CTSI BERD Core's Research-on-a-Napkin opportunity, which will also involve other CTSI cores, and will provide project-specific advice to enhance pilot study full proposal applications.
- For proposals involving human subjects research, investigators are required to register their study with Central Study Registration (CSR) prior to submission of the full proposal. Pilot studies proposals that involve human subjects that are not registered in CSR will not be accepted. To begin the CSR process, a proposal document (at minimum) is required. The HRP-503-Protocol template can be found in the Click portal, within the IRB Library section, under the “Templates” tab.
(1) If you are submitting your protocol to the IRB for determination of "Not Human Subjects Research."
(2) If you are seeking "Exempt Status" from the IRB for your study.
(3) Due to reporting requirements, studies involving the use of clinical data (e.g., EHR data) must be registered within the system. If bypassing CSR, please leave a comment in Click indicating you are seeking one of the above listed determinations. This will allow the IRB Intake Coordinator to know your study should not be returned for registration.
- For proposals involving human subjects, following submission of the full proposal, the Principal Investigator must submit all necessary documentation (e.g., IRB protocol and related materials, human subjects education if applicable, ClinicalTrials.gov registration status if applicable, and conflict of interest) to the CTSI Clinical Research Facilitators for pre-review.
- For proposals involving animal subjects, the Principal Investigator must submit their protocol to IACUC prior to submission of the full proposal.
*PIs from Roswell Park Comprehensive Cancer Center should follow a similar process while utilizing the RPCCC Click and IRB.