Data Management and Statistical Support

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Objectives The objective of this Core is to provide additional facilities and manpower in the areas of data management and statistical support for the proposed CIPRA projects. To address the statistical needs of both Thai and Cambodian CIPRA projects, this core targets building capacity and training within both new and existing staff. A data safety monitoring board will be constituted to oversee the progress of each of the projects. Specific aims 1. to employ a full-time data manager to supervise all aspects of data collection and centralized data entry 2. to employ two study monitors, two data entry clerks and a clinical research assistant 3. to employ a Ph.D. statistician part-time as core leader in the first two years of the CIPRA projects 4. to employ a local Ph.D. bio-statistician on-site part-time in the first two years of the CIPRA projects 5. to employ a master's level bio-statistician 6. to train a current master's level Thai bio-statistician to the PhD level and to employ her as full-time core leader beginning in the third year of the CIPRA projects 7. to design, print and distribute study protocols and documentation for use in all CIPRA projects 8. to provide necessary hardware and software to allow transfer, storage and statistical analysis of data, including facsimile machines, new computers, statistical software, photocopier and CD writer (for data backup), and document storage cabinets for patient and study records 9. to establish a data safety monitoring board (DSMB) Methods This core will be led by Dr Matthew Law, who has 10 years of experience as head of the biostatistics department at National Centre in HIV Epidemiology and Clinical Research (NCHECR) in Sydney. The current data manager at HIVNAT, with six years experience, will head the data management component of the core. The current biostatistician at HIV-NAT has commenced PhD training in NCHECR under the supervision Mathew Law. She will return to HIV-NAT to be core leader following her training. Thirty plain paper facsimile machines will be installed at the study sites in Thailand and Cambodia and at HIV-NAT to facilitate data transfer. A license for SPSS software will be purchased. A DSMB will be constituted, comprising members from Thai