Data Coordinating Center definition

Data Coordinating Center. An agreement governing responsibilities for the overall data management, monitoring, communication, and general oversight for a Multi-Center clinical trial. The agreement may be designated either by a for profit entity or by mutual agreement of the participating sites.
Data Coordinating Center. An agreement wherein a Coordinating Center is responsible for overall data management, monitoring and communication among all sites, and general oversight of the conduct of a human subjects research project for a Multi-Center clinical trial. A Coordinating Center may be designated either by a sponsor or by mutual agreement of the participating sites. The Principal Investigator (PI) wishing to act as the Coordinating Center PI for a multi-site research effort must submit an IRB application. IRB review and approval in which s/he describes the Coordinating Center functions and responsibilities. The PI may submit either of the following: (a) for studies in which there will be no subject enrollment at the Icahn School of Medicine at Mount Sinai (“ISMMS”), a specific Coordinating Center application and protocol that outline the responsibilities of the Center and the Coordinating PI. This must be submitted to the IRB for review and approval prior to initiating the Center’s functions; or (b) for studies in which there will be subjects enrolled at ISMMS, an application and protocol in which the PI outlines the conduct of the research with participants at ISMMS. In such cases, a specific Coordinating Center protocol may or may not be available as a separate protocol submission. If not, the Coordinating Center functions should be described in protocol submitted or in a sub-protocol.

Examples of Data Coordinating Center in a sentence

  • The Neurological Clinical Research Institute (“NCRI”) at MGH is the Clinical Coordinating Center for NEALS research studies (the “NCRI CCC”) and also operates the Data Coordinating Center for the studies (the “NCRI DCC”).

  • All researchers who intend to submit an application are required to contact the ACSR Central Operations and Data Coordinating Center ▇▇▇▇▇@▇▇▇▇.▇▇▇▇.▇▇▇ before proceeding.

  • These central resources will function and be supported under the Data Coordinating Center.

  • Data Coordinating Center retains all right, title, and interest in the Research Datasets sent by the Data Coordinating Center to a Data User to the extent they contain any results, data, or analyses generated from the Data Coordinating Center’s management of Query Results.

  • Other supporting documentation of the event may be requested by the Data Coordinating Center (DCC)/study sponsor and should be provided as soon as possible.

  • The MRI portion of this study was managed by the ▇▇▇▇ CRN Radiology Coordinating Center (RCC) in conjunction with the ▇▇▇▇ CRN Data Coordinating Center (DCC).

  • Since these records necessarily contain subject identifiers, they will not be sent to the Data Coordinating Center at Dartmouth or to the University of Michigan.

  • A distribution system will be developed by the NIDDK in collaboration with the ▇▇▇▇ Data Coordinating Center to ensure the ▇▇▇▇ Clinical Centers have an adequate supply of these items at all times.

  • The PERCH Core and Data Coordinating Center Members will have access to the data from all sites.

  • The NIDDK will be responsible for the appropriate study labeling and distribution, through the Data Coordinating Center, of the Test Agent and placebo.

Related to Data Coordinating Center

  • Service coordination means a specialized care management service that is performed by a Service Coordinator and that includes but is not limited to:

  • Services Coordinator means an employee of the community developmental disability program or other agency that contracts with the county or Department, who is selected to plan, procure, coordinate, and monitor Individual Support Plan services, and to act as a proponent for individuals with developmental disabilities.

  • Project Coordinator means the employee of Alamo Colleges District designated in Exhibit A hereto who will manage the relationship between Alamo Colleges District and Contractor. The designated employee will be knowledgeable of the Project and be experienced in managing projects similar to the one established herein.

  • Service Coordinator has the meaning set forth in Section 2.2.

  • Project Managers means the individuals identified in Section 12 of this Agreement who are authorized by TriMet and Subrecipient respectively to send and receive communications regarding this Agreement.