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RDCRN Data Management Coordination Center (DMCC) U54

RDCRN Data Management Coordination Center (DMCC) U54. RFA-OD-08-002 Overview. Responsibilities according to original RFA: Provide a secure, customizable, scalable coordinated clinical data management system

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RDCRN Data Management Coordination Center (DMCC) U54

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  1. RDCRN Data Management Coordination Center (DMCC) U54 RFA-OD-08-002 Overview

  2. Responsibilities according to original RFA: • Provide a secure, customizable, scalable coordinated clinical data management system • Provide a portal and tools for integration of developed and publically available datasets • Provide for web-based recruitment and referral • Provide a user-friendly resource site for the public, research scientists, and clinicians • Provide support for a comprehensive and integrated approach to data collection, storage, and management • Incorporate new approaches to distributed computing • Address privacy and confidentiality issues and allow multiple levels of data sharing

  3. Expansion of responsibilities over the years • Statistical support during protocol development • Support in form development for the collection of data in multi-center studies, verifying all data, developing tests, and maintaining software for within-form edit checks at data entry • Logistical and administrative assistance for Steering Committee meetings • Provide other operational support for Network such as communications, subcommittee meetings, meeting minutes • Produce and maintain documents, including Network Operating Policy and Procedures manuals • Develop and maintain interactive email system for communication within Network • Develop uniform protocols for data and specimen collection • Provide support services for the production of reports, graphics, and other materials • Monitor Network protocol adherence, data collection and data submission, and reporting violations to the Steering Committee

  4. Major changes in responsibilities • Statistical support during protocol development • Will be the responsibility of the consortium • Support in form development for the collection of data in multi-center studies, verifying all data, developing tests, and maintaining software for within-form edit checks at data entry • Consortia have the option of developing their own forms– DMCC will work with consortia to integrate forms into Network • Logistical and administrative assistance for Steering Committee, PRC, DSMB meetings • Protocol development and DSMB responsibilities will reside with the NIH Institutes

  5. Expectations for the transition • The DMCC will be awarded approximately 6 months prior to the expiration of the DTCC U54. Both the DMCC and the DTCC will be fully funded during this time. • It is expected that the DTCC will work with the DMCC awardee to provide a smooth transition in Network support and data migration. • Each consortium covers between 3 and 8 related diseases. There are on average 7 performance sites per consortium (approx. 4-11). • There are approximately 30 protocols currently open. It is possible that all 30 could be ongoing on August 1, 2009. • While all consortia funded under RFA-OD-08-001 must propose at least 2 protocols, it is highly unlikely that any will start in the first 6 months of the new consortia funding period. Based on previous experience, it is expected that several consortia will start 1 new protocol in the first year and that approx. 6-8 protocols will start each year in years 2-4. No protocols generally start in year 5.

  6. Expectations for the transition (cont’d) • The data coordination center has always been fully funded and will continue to be fully funded in the new funding period. • There are no requirements that the proposed system follow previous hardware or software designs. It is expected that the proposed system be compatible with a wide range of systems to facilitate data transfer from performance sites as well as from the DTCC. • It is expected that the proposed system be largely web-based, but this does not preclude proposing other cutting-edge technologies that are not web-based.

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