PPDs Application for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01 Clinical Trial Not Allowed)

Project Summary/Abstract To support DAIT's efforts to increase understanding of the causes and mechanisms that lead to the development of immunologic diseases and to expand knowledge that can be applied to improving techniques of diagnosis, treatment, and prevention, the T-SCCC will provide experienced staff, standardized procedures,

optimal facilities, and integrated systems to transition-in and support statistical and clinical coordinating center deliverables for NIAID/DAIT's clinical research programs, investigator-initiated clinical trials, and other NIAID-funded clinical programs in transplantation. The T-SCCC will empower DAIT's transplantation

researchers to address key scientific questions and share resultant data by efficiently managing program and study resources and facilitating communication and collaboration among stakeholders from initial study and protocol concepts through to peer-reviewed manuscripts. The T-SCCC will: 1) provide experienced scientists and statisticians to collaborate with clinical investigators

and DAIT to develop innovative statistical design and analysis plans for concept and full study proposals; conduct interim and final statistical analyses of clinical and mechanistic study data that will be used to that yield optimal results for scientific manuscripts and reports for publication and presentation; 2) provide high-

quality adverse event/serious adverse event reporting that supports Data and Safety Monitoring Boards, other safety committees/bodies, and regulatory health authorities in ensuring study participant safety; 3) provide dedicated, experienced protocol teams to help develop, review, and revise protocols and protocol-related

documents and provide site training on protocol-related processes and procedures at startup and throughout studies to accommodate changes; 4) establish and maintain a biospecimen tracking database and assemble and ship assay kits and/or bulk supplies that include biospecimen labeling packets (kitting) for mechanistic studies;

5) help ensure complete, accurate clinical data collection and security by supporting data management plan development and study database design in collaboration with the CDSMC, investigators, SMTs, and DAIT; 6) collaborate with the CDSMC, SMTs, and DAIT to monitor study participant safety, implement of safety

procedures and adhere to safety oversight and reporting requirements; 7) provide and maintain secure, user- permissioned, internet-based clinical study collaboration portals, to house clinical trial information and study- specific files and provide a mechanism to receive study data securely from the CDSMC for analysis, reporting,

and sharing; 8) develop and implement plans for collaborative project management, communications, and support of the complex web of stakeholders and processes involved in delivering the T-SCCC to ensure efficient, valid, and ethical study oversight, reporting, and conduct; and 9) use well-developed standards and

methods to build and implement a comprehensive, cross-functional quality assurance/quality control plan that standardizes quality processes across deliverables and facilitates assessments of T-SCCC performance.