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CIBMTR Center Reference Guide CIBMTR Center Reference Guide CIBMTR CENTER REFERENCE GUIDE OVERVIEW OF CIBMTR Stem Cell Therapeutic Outcomes Database (SCTOD) Levels of Participation • Transplant Essential Data (TED) Only Centers • Comprehensive Report Form (CRF) Centers • BMT CTN Participation o Reimbursement CENTER MEMBERSHIP INFORMATION IRB Approvals EBMT Centers CIBMTR ACCESS FormsNet™2.0 • SecurID® and Log‐in CIBMTR Portal • Data Back to Centers (DBtC) • FormsNet™ Center Volume Data TRAINING AND RESOURCES Mentor Program Data Manager Education Tips from the Network Cibmtr.org website STUDIES CIBMTR Observational Studies Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Resource for Clinical Investigations in Blood and Marrow Transplant (RCI BMT) Study of long‐term complications of Kepivance (KGF) Comparison of intravenous busulfan versus total body irradiation for pretransplant conditioning (Otsuka Study) ATTACHMENTS A: CIBMTR Working Committees B: Glossary of Abbreviations C: New Center Information Sheet D: Center Change Form E: Forms Submission Process ENCLOSURES CIBMTR Progress Report CD Revision 2.0 – Page 1 OVERVIEW OF CIBMTR The Center for International Blood and Marrow Transplant Research (CIBMTR) collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy research worldwide. A combined research program of the National Marrow Donor Program (NMDP) and the Medical College of Wisconsin (MCW), the CIBMTR facilitates critical, cutting‐edge clinical research that has led to increased survival and an enriched quality of life for thousands of patients. The research is accomplished through scientific and statistical expertise, a large network of transplant centers and clinical database of more than 300,000 transplant recipients. CIBMTR is comprised of four main programs: observational research, clinical trials support, immunobiology and statistical methodology. In addition, the NMDP Network— now called the “Be the Match Registry”— has grown to more than 7 million donors and nearly 100,000 cord blood units, the largest and most racially and ethnically diverse registry of its kind in the world. CIBMTR collects observational data for HCT recipients from approximately 450 centers around the world, who register about 15,000 new transplants each year. Nineteen Working Committees design and conduct studies that focus on specific diseases and complications. Research looking at biologic and genetic factors that may affect transplant outcomes (immunobiology) is also underway. Large clinical trials testing new strategies in blood and marrow transplantation are coordinated with NMDP and the EMMES Corporation, and performed under the auspices of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). Scientific and statistical support for small clinical trials is provided to researchers worldwide through the Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI BMT). More information about the CIBMTR and its programs can be found in several places. The CIBMTR Progress Report is published yearly and is available in print format, on CD or online at http://www.cibmtr.org/About/AnnualReports/index.html. The CD is included in this Reference Guide as an enclosure. CIBMTR also publishes a progress report on the BMT CTN annually, which can be found online at https://web.emmes.com/study/bmt2/BMT%20CTN%20Annual%20Report_July%202009.pdf. For those interested in a printed version of the RCI BMT report, please contact Sarah Mull at [email protected]. CIBMTR also publishes a semi‐annual newsletter summarizing activities and highlighting the research work of the Working Committees and other CIBMTR activities. The Summary Slides are an annual report on data submitted to the CIBMTR. Part 1 focuses on trends in the use of HCT according to donor type, graft sources, patient age and transplant regimes. Early outcomes such as mortality rates at day 100 post HCT and causes of death are also included this series. Part II focuses on survival outcomes by age, disease, transplant and donor type, and by conditioning regimen intensities. Newsletters and Summary Slides are available at: http://www.cibmtr.org/ReferenceCenter/index.html Revision 2.0 – Page 2 Stem Cell Therapeutic Outcomes Database (SCTOD) The Stem Cell Therapeutic and Research Act of 2005 (Public Law 109‐129) established the C.W. Bill Young Cell Transplantation Program (the Program), which is overseen by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services. The C.W. Bill Young Cell Transplantation Program is an expansion of the National Bone Marrow Donor Registry (the Registry). The Registry was begun in 1987 through a grant from the Navy and formally established in 1990 as a responsibility of the Department of Health and Human Services. The first transplant under its auspices took place in 1987. The four components of the C.W. Bill Young Cell Transplantation Program are: • Office of Patient Advocacy and Single Point of Access (OPA/SPA); • Bone Marrow Coordinating Center (BMCC); • Cord Blood Coordinating Center (CBCC); • Stem Cell Therapeutic Outcomes Database (SCTOD). While some of the activities of the Program are similar to those of the preceding NMDP Registry, the current Program has the added responsibility of collecting, analyzing and reporting on outcomes for all allogeneic transplants and on other therapeutic uses of blood stem cells. The Program also has expanded what the National Bone Marrow Donor Registry was doing to increase the number of available marrow donors and cord blood units. Initial contracts were awarded to thirteen U.S. Cord Blood Banks for the NCBI. The BMCC, CBCC and OPA/SPA contracts were awarded to NMDP. The SCTOD Contract was awarded to the CIBMTR. Congress has legislated that outcomes data must be collected on all allogeneic transplants, both related and unrelated, where either the donor or the recipient resides in the United States or on transplants performed elsewhere with products collected in the United States. The CIBMTR, as recipient of the SCTOD contract, is responsible for administration of this activity and for collection and analysis of the data. The SCTOD required the following changes in practice and procedures at CIBMTR: • Development of new systems to collect data electronically; • Enhanced efforts to develop a standard dataset of clinical HCT data; • New requirements for U.S. centers to report outcomes data for all allogeneic transplantations; • Development of a related donor‐recipient research sample repository; • Systems to make more data publicly available; • Broadened reporting of U.S. transplant center‐specific survival rates to include outcome of related donor transplants; • Data collection on uses of hematopoietic stem cells for new therapeutic applications (e.g., regenerative medicine). Collaborative efforts have allowed CIBMTR and NMDP to meet the new challenges and requirements dictated by the SCTOD. The two campuses are strategically adjusting internal procedures to collect Revision 2.0 – Page 3 data on a harmonized paper form and electronic data collection system. The SCTOD is offering new research opportunities to the transplant community and streamlining data collection. Articles about the SCTOD and the C. W. Bill Young Program can be found in the December 2006 CIBMTR Newsletter and the November 1, 2006 ASBMT eNews. 2007 BMT Tandem Meeting SCTOD Web Presentations may be viewed online at http://www.asbmt.org/News/Outcomes. Data from a transplant recipient are considered part of the SCTOD if they meet at least one of the following criteria: • Allogeneic HCT occurs at a U.S. transplant center • Stem cell collection is performed within the United States • Donor is obtained from within the United States Recipient data are not considered part of the SCTOD if they meet one of the following criteria: • Recipient receives an autologous HCT • HCT does not occur in the United States and the stem cell donor resides outside of the United States • Cord blood unit is obtained from a cord blood bank outside of the United States and the transplant occurs outside of the United States Levels of Participation The CIBMTR offers two levels of participation, as a Transplant Essential Data (TED level) Program or as a Comprehensive Report Form (CRF level) Program. Using each center’s designation of preferred reporting status, as described above, the CIBMTR applies a selection system that assigns recipients, as reported to CIBMTR, to the appropriate data reporting track: Form selection algorithm: CIBMTR has developed an algorithm to determine which set of forms will be required for each HCT recipient. The goal of the algorithm is to randomly select an epidemiologic sample of recipients for whom a Comprehensive Report Form will be requested. The algorithm includes, but is not limited to, type of HCT, age of the recipient, disease, etc. The algorithm is periodically reviewed to assess the burden of data submission for transplant centers. Transplant Essential Data (TED) only centers A transplant center designated as TED only is required to submit the following forms: • Unique ID Assignment (CRID) (Form 2804), due for recipient’s first HCT only • Pre‐TED (Form 2400) • Post‐TED (Form 2450) • The HCT Infusion Form (Form 2006) is required for some allogeneic recipients See attachment F for more detail. Revision 2.0 – Page 4 Comprehensive Report Form (CRF) centers Comprehensive Report Form Centers are those that have agreed to complete either
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