Network Committees
The Network’s policy, guidance, implementations and objectives are managed by a set of advisory and steering committees. Each committee attends to specific roles and responsibilities which ensure credible clinical trials.
The Network Committees are:
A. Network Steering Committee (NSC)
NSC is the highest leadership of the Network consisting of one voting representative from participating countries and international institutional partners for two to four years terms.
The NSC sets mission and objectives of the Network and is responsible for regulating decisions on specific clinical trials and approving Network protocols.
The NSC also manages Trial Operations Committee, Data Safety Monitoring Board, training capacities, public relations including media and publications policies, and operational issues of the whole Network.
The current participating countries are: Thailand, Vietnam, and Indonesia
The international institute partners are NIAID, Oxford University, Wellcome Trust, and WHO. The NSC convenes quarterly, including one annual meeting.
B. Trial Operations Committee (TOC)
TOC manages the trial design and development of study protocols.
It supervises ongoing Network studies especially in the aspect of trial progress, adherence to the protocol, patient safety, and takes into account potential factors that might affect implementation of clinical trials.
The TOC is also in charge to select Principal Investigator of a study in participating hospitals.
The TOC membership includes one representative from each participating country, selected subcommittees, and interested partners.
The TOC convenes monthly with Minutes of the Teleconference Calls distributed to all participating members.
C. Site Management Committee (SMC)
The SMC works closely with participating hospitals and institutions (also known as “Sites”) to implement and complete the Network study based on protocols.
The SMC leads and coordinates sites, from preparation planning (infrastructure and human resources), training development and delivery for site staff, to quality assurance and quality management of sites’ activities. The SMC supports sites to deal with challenges during the study implementation.
D. Data Management Committee (DMC)
The DMC provides support to research sites to implement and complete data management activities.
The DMC consists of Network’s biostatistician, data managers, clinical monitoring representative and data management representative from NIAID, and the NCC data manager.
The Network collaborated with Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS) on November 7, 2008 to officially launch of DataFax as the new clinical trial database management system. A total of 75 Network staff participated in the DataFax introductory training earlier in September. The Datafax is primarily used for SEA001 study. BIOPHICS will provide further trainings in 2009 for network staff in the following topics: Good Clinical Data Management Practice and Computerized System Validation.
E. Reference Laboratory Committee (RLC)
The RLC is focussed on setting up measurement for Network study and serves as a forum to discuss and decide study-specific laboratory issues and provide laboratory advices for protocols under development.
F. Clinical Laboratory Committee (CLC)
The CLC is responsible to address study issues arise from routine laboratory testing from all sites (including biochemistry, haematology and microbiology labs).
G. Pharmacy Committee (PC)
The PC supports research pharmacy staff at sites to fulfil Good Pharmacy Practice (GPP) and to maintain study participant safety and study data integrity according to Good Clinical Practice (GCP). It also oversees each clinical pharmacy at sites to establish record keeping system of study product management that is in compliance with FDA and local regulations.