PROJECT SUMMARY/ABSTRACT Hematopoietic cell transplantation (HCT) and adoptive cellular therapy (ACT) offer curative treatment for di- verse malignant and non-malignant diseases. This field is rapidly developing new strategies for patient assess- ment, cell selection and manipulation, and pre- and post-procedure treatment. New prophylactic and therapeu- tic modalities require evaluation in definitive clinical trials, as does the role of HCT versus other therapies. HCT/ACT trials face unique challenges, including the small number of procedures done at each center, the di- verse indications for treatment requiring dissimilar approaches, the complexity of the interventions, the multi- ple, competing risks in the early post-treatment period, and important, though infrequent, late effects. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) was established in 2001 to perform scientifi- cally meritorious, prospective clinical trials to address these issues. The Network has launched 62 trials with the support of a Data Coordinating Center (DCC) formed through a consortium of organizations with synergis- tic expertise: the Medical College of Wisconsin (MCW), the National Marrow Donor Program (NMDP), and The Emmes Company. This unique Consortium leverages the critically important real-world database of the Center for International Blood and Marrow Transplant Research (CIBMTR), jointly operated by MCW and NMDP. The DCC consortium proposes to continue supporting the Network and use its expertise to provide efficient devel- opment, implementation, and completion of high-quality clinical trials, including concept evaluation and prioriti- zation; protocol development with appropriate and innovative statistical designs; timely activation and accrual; monitoring for safety, compliance, and data accuracy; and analyzing and disseminating results. The DCC con- sortium will coordinate and support all BMT CTN activities by: maintaining a state-of-the-art, secure database and systems for acquisition and storage of biospecimens, including development of a repository of longitudinal, clinically annotated specimens from a diverse cross-section of patients receiving cell and gene therapies for non-malignant blood diseases; ensuring data quality, laboratory compliance, and adherence to regulatory re- quirements; managing contractual arrangements and fiscal activities; monitoring and improving center and overall Network performance; supporting logistics for Network Committees and activities; enhancing access to trials for all patients regardless of ancestry, demographics or socioeconomics; and fostering the next genera- tion of researchers from diverse backgrounds by providing didactics, mentorship, and meaningful career-en- hancing experiences. The DCC will continue to leverage Network resources and expertise by collaborating with the National Cancer Institute-funded National Clinical Trials Network Groups, CIBMTR’s Working Committees, industry partners, and ...