Questions and Answers for RFA-AI-22-057

Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01, Clinical Trial Not Allowed)

NIH published the funding opportunity announcement (FOA) RFA-AI-22-057, Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01, Clinical Trial Not Allowed) on August 9, 2022.

Updated October 31, 2022. We added the second through fifth questions below. 

Each time we add new questions or revise, we will revise the dated note shown at the top of this page to describe the latest update.

In the course of protocol development, the T-SCCC will be responsible for working with the protocol team to develop an appropriate randomization scheme when needed. The implementation of the randomization scheme is the responsibility of the CDSMC.

Although the CDSMC FOA (RFA-AI-22-058) does mention a sample tracking system, we are requiring that applicants for the T-SCCC provide a plan for supporting the Transplantation Branch mechanistic studies by establishing and maintaining an independent biospecimen tracking system. In the T-SCCC FOA, check Section I. Funding Opportunity Description, Background section, Biospecimen Labeling, Shipping, and Tracking subheader.

Per the RFA, the T-SCCC will be expected to support approximately 40 active clinical trials, which may be in development, enrolling, in follow-up, or in analysis and manuscript preparation. We do not expect that 40 studies will be enrolling simultaneously. Most of the trials in the transplant portfolio are conducted under investigational new drug (IND) applications or investigational device exemptions (IDE). Target accrual ranges from 10 to several hundred participants, and study duration ranges from approximately three to seven years.

In addition to the clinical aspects of the trial, all trials, whether interventional or observational, include in-depth studies of immunologic mechanisms utilizing a range of state-of the-art laboratory technologies and requiring extensive data and specimen collection and sophisticated statistical analysis approaches.

Per the RFA, multiple PD/PIs are allowed. The application will need to provide a justification as to how these individuals will divide the responsibilities and percent effort so that the commitment is no less than 7.2 person months per year. Refer to NIH’s Is there a ceiling on multiple PD/PIs? For more information, refer to NIAID’s general guidance and advice on Multiple Principal Investigators.

NIAID intends to commit $9 million in fiscal year (FY) 2023 to fund a single award. The $9 million funding commitment includes both direct and indirect costs. NIAID can confirm that the intended FY 2023 funding commitment of $9 million equates to Year 1 of the cooperative agreement and that subsequent years will be funded at a similar level.

Check Section VII of the FOA for NIH scientific/research, peer review, and financial/grants management contacts.
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