The Data Management and Coordinating Center (DMCC) houses all data for the RDCRN centrally via in-house scalable and customizable electronic data capture systems; the DMCC system has collected and stores over 22 million data points. Some of the data systems built by the DMCC for the RDCRN include: internal members' only site with calendar, document navigation, comprehensive member directory with over 2400 Consortium members and 400 institutions, committee structure, multi-tiered security (protocol-based, user-based, consortium-based, folder-based security structures); specimen collection, shipment, and tracking system; pharmacy shipment, inventory, and dispensation system; randomization system; participant management system with electronic case report forms (eCRFs); (online) eligibility voting system; standardized and automated report sets (accrual, demographics, adverse events, compliance, study status) updated no less than monthly; automated XML/CSV data sets with associated data dictionaries; Adverse Event Data Management System (AEDAMS) for real time reporting, submission, review, and distribution of adverse events as they occur; and a Network Contact Registry.
The DMCC is funded by ORDR, NCATS and NINDS to provide a secure, customizable, scalable coordinated clinical data management system for the collection, storage, and analysis of diverse data types from clinical researchers working on many different types of rare diseases. In the first RDCRN grant cycle (2003-2009), the DMCC was funded by NCRR to provide statistical and project manager support for each of the 10 funded consortia. In the second grant cycle (2009-2014), each consortium was responsible for identifying an administrative core (project manager support) and statistical support; all 5 of the re-funded consortia from the first grant cycle entered into a sub-contract with the DMCC for the DMCC to provide the administrative core and statistical support. There were 19 consortia funded initially in 2009.
The Center will support the Consortia by supplying a data management and analysis infrastructure; user-friendly resources for the public and web-based recruitment and referral tools; logistical and administrative assistance; and, data coordination, management and sharing. Additionally, the following are DMCC objectives:
- Provide a scalable, coordinated, clinical data management system for collection, storage, and analysis of data of RDCRCs. This is achieved through web-based solutions that can be specialized for each consortium and studies within the consortium. System functionalities include treatment assignment, pharmacy management, event scheduler, specimen management, adverse event data management system, and image uploading system.
- Provide support for a comprehensive and integrated approach to data collection, storage and management, and the integration of clinical data with other unique data, including genetic, imaging, pathologic, and laboratory data.
- Provide a portal and tools for integration of developed and publicly available datasets for cross-disease data mining at RDCRCs. These portal and tools are implemented using Network approved data standards through the use of select browsers, search tools and interfaces.
- Provide web based recruitment and referral tools, including the Contact Registry.
- Provide a user friendly resource site for the public, research scientists, and clinicians. The RDCRN Public Web site contains Network and Consortium specific information, and is an important source of information for the various rare diseases studied under the RDCRN.
- Provide administrative support to the Network in the form of producing and maintaining all Network documents, including Network Operating Policy and Procedures manuals; and "listserv" interactive email system for communication within the Network.
- Monitor Network protocol adherence, data collection and data submission, and report violations to the Steering Committee as well as other required entities; and conduct site visits.
Jeffrey P. Krischer, Ph.D., Principal Investigator, RDCRN
Professor, Department of Pediatrics Division of Bioinformatics and Biostatistics
University of South Florida
Jennifer L. Harris, MSPH, CCRP, Assistant Director
RDCRN Main Fax: (813) 910-5997
1. Richesson R, Young K, Malloy J, Lloyd J, Krischer J. A contact registry for persons with rare diseases: a tool for recruiting and retaining participants in a clinical research network. Paper presented at: Inventory and Evaluation of Clinical Research Networks; May 31, 2006; Washington, DC.
2. Richesson R, Young K, Malloy J, Guillette H, Krischer J. A contact registry for persons with rare diseases: a tool for recruiting and retaining. Paper presented at: Clinical Trials Expo, Annual Symposium of the American Medical Informatics Association; November 13, 2006; Washington, DC.
3. Richesson R. A Contact Registry for Persons with Rare Diseases: A Tool for Recruiting and Retaining Participants in a Clinical Research Network. Paper presented at: Inventory of Clinical Research Networks; May 31, 2006, 2006; Washington, D.C.
4. Richesson R, Young K, Malloy J, Guillette H, Krischer J. A Contact Registry for Persons with Rare Diseases: A Tool for Recruiting and Retaining Participants in a Clinical Research Network. Paper presented at: Clinical Research Expo, American Medical Informatics Association Annual Symposium; November 12, 2006, 2006; Washington, D.C.
5. Richesson R, Young K, Lloyd J, Adams T, Guillette H, Malloy J, Krischer J. An Automated Communication System in a Contact Registry for Persons with Rare Diseases: Tools for Retaining Potential Clinical Research Participants. Paper presented at: American Medical Informatics Association Annual Symposium; November 10-14, 2007; Chicago, IL.
6. Richesson R, Lee H, Cuthbertson D, Lloyd J, Young K, Krischer J. An automated contact registry for persons with rare diseases: scalable tools for identifying and communicating with clinical research participants. Paper presented at: International Conference on Rare Diseases and Orphan Drugs (ICORD); May 20-22, 2008; Washington, DC.
7. Rachel L. Richesson, Jamie F. Malloy, Kathleen Paulus, David Cuthbertson and Jeffrey P. Krischer. An Automated Standardized System for Managing Adverse Events in Clinical Research Networks. Drug Safety. 2008; Vol. 31; No. 10; 807-822.
8. Richesson R. Linking Patients to Research Programs and Treatment Centers -The Value of Patient Registries and Experiences in Recruiting Patients for Clinical Trials -Report of Working Group: Utilization and Expansion of a Patient Contact Registry to Recruit Patients to the NIH Rare Diseases Clinical Research Network. Paper presented at: 5th International Conference on Rare Diseases and Orphan Drugs; February 23-25, 2009; Rome.
9. Richesson R, Shereff D, Lloyd J, Young K, Guillette H, Paulus K, Harris J, Cuthbertson D, Krischer J, Rare Diseases Clinical Research Network. RDCRN Contact Registry to Support Research in Rare Diseases. Poster presented at: Yale Center for Clinical Investigation. 5th Annual Clinical Research Management Workshop; June 4-5, 2012; New Haven, CT.
10. Richesson RL, Young K, Lloyd J, Adams T, Guillette H, Malloy J, Krischer JP. An automated communication system in a Contact Registry for persons with rare diseases: tools for retaining potential clinical research participants. AMIA. Annu. Symp. Proc. 2007:1094.
11. Richesson RL, Lee HS, Cuthbertson D, Lloyd J, Young K, Krischer JP. An automated communication system in a contact registry for persons with rare diseases: scalable tools for identifying and recruiting clinical research participants. Contemp. Clin. Trials. Jan 2009;30(1):55-62.
12. Rubinstein Y, Groft S, Bartek R, Richesson R. Creating a Global Rare Disease Patient Registry linked to a Rare Diseases Biorepository Database: Rare Disease - HUB (RD - HUB). Contemp. Clin. Trials. 2010.
13. Rubinstein YR, Groft SC, Bartek R, Brown K, Christensen RA, Collier E, Farber A, Farmer J, Ferguson JH, Forrest CB, Lockhart NC, McCurdy KR, Moore H, Pollen GB, Richesson R, Miller VR, Hull S, Vaught J. Creating a global rare disease patient registry linked to a rare diseases biorepository database: Rare Disease-HUB (RD-HUB). Contemp. Clin. Trials. Sep 2010;31(5):394-404.
14. Richesson RL, Sutphen R, Shereff D, Krischer JP. The Rare Diseases Clinical Research Network Contact Registry update: features and functionality. Contemp. Clin. Trials. Jul 2012;33(4):647-656.