The Tuberculosis Research Unit (TBRU) Coordinating Center was established at Case Western Reserve University in dedicated space provided by the School of Medicine in 1995. The objective was to provide adequate coordination of contract activities for all CWRU and remotely based investigators and sites.

Work Statement

The TBRU will organize and administer the basic research and clinical activities of the contract. The prime contractor shall manage and coordinate all contract sites and activities, including the following:

1. Plan, conduct, and report on approved clinical studies and associated research studies. This shall include developing the specifics of experimental design, receiving and shipping of reagents and samples, coding of patients, reagents, and samples, and coordinating all subcontractor activities (if applicable). This shall also include conducting all clinical studies in compliance with DMID/NIAID policy and in coordination with the Clinical and Regulatory Affairs Branch, DMID/NIAID.
2. Manage the information generated, including transmission, storage, confidentiality, retrieval, validation, and statistical analysis.
3. Coordinate the preparation of all manuscripts and presentations involving studies performed under this contract. Establish and implement a publication policy for results of all contract-supported studies. All publications and presentations shall acknowledge NIAID support. The Government, through the Project Officer, shall have access to all data generated with the support of this contract.
4. Establish and/or manage the clinical and laboratory facility(ies) to support the various studies.
5. Organize and attend meetings for the purposes of future planning, protocol and study development and/or evaluation, data discussion between co-investigators and other essential personnel, and meeting with NIAID staff and FDA staff, and convening of Data Safety and Monitoring Boards (DSMB). These meetings shall be arranged at the direction of the Project Officer and shall include scientific advisors at the direction of the Project Officer.

Description and Operation

The Tuberculosis Research Unit (TBRU) is responsible for the planning, managing, monitoring and reporting of basic research and clinical activities conducted under this NIH contract. To accomplish the contract objectives, the TBRU has developed a Coordinating Center to assist the Program Directors, Investigators and NIH Project Officer in the organization and administration of research directed at achieving the contract objectives. The Leaders of the Coordinating Center work very closely with the research component leaders specifically, to assure that objectives for all projects are well supported.

The Coordinating Center is based at the Case Western Reserve University School of Medicine (in the overall Tuberculosis Research Unit office location). The Coordinating Center’s specific activities include:

1. An Administrative Center (AC) to oversee, monitor and report on fiscal, regulatory, and all other general administrative activities to adequately coordinate the research endeavors at all sites. Specific activities include: Overall communications/meeting support; coordination of funding and project reviews; overall fiscal management; report generation/requirements; protocol development and regulatory oversight; foreign site supplies provision and assistance as needed.
2. A Data Coordinating Center (DCC) to integrate and centralize data from all clinical trials, observational studies and basic science research being conducted at the proposed sites. The DCC will provide support and coordination for the scientific, statistical, data processing and operational aspects of research conducted by the TBRU. Specific activities include: Study/protocol design and development; data collection systems and study management; quality assurance and quality control; statistical analysis; maintenance of study data, and required documentation/reporting.

Staff

Ms. Marla Manning oversees the Administrative aspects of the Coordinating Center. Dr. Christopher Whalen and Ms. Dana Jankus oversee the Data aspects of the Coordinating Center.

Administrative staff include a Regulatory Consultant, Financial Coordinator, Supplies Coordinator, and Administrative Coordinator. Data Management staff include an Analyst, dedicated Project Data Managers, and Data Entry clerks. All staff maintain regular ties with CWRU and remote researchers and counterparts at the multiple project sites. Routine conference calls and meetings are held to assure communications are maintained for TBRU activities.

Provision of a central support unit at CWRU for all TBRU contract activities has proven essential for a well-integrated, and coordinated multidisciplinary contract.