ObjectivesThe objective of this Core is to provide additional facilities and manpower in the areas of data management andstatistical support for the proposed CIPRA projects. To address the statistical needs of both Thai and CambodianCIPRA projects, this core targets building capacity and training within both new and existing staff. A data safetymonitoring board will be constituted to oversee the progress of each of the projects.
Specific aims1. to employ a full-time data manager to supervise all aspects of data collection and centralized data entry2. to employ two study monitors, two data entry clerks and a clinical research assistant3. to employ a Ph.D. statistician part-time as core leader in the first two years of the CIPRA projects4. to employ a local Ph.D. bio-statistician on-site part-time in the first two years of the CIPRA projects5. to employ a master's level bio-statistician6. to train a current master's level Thai bio-statistician to the PhD level and to employ her as full-time core leaderbeginning in the third year of the CIPRA projects7. to design, print and distribute study protocols and documentation for use in all CIPRA projects8. to provide necessary hardware and software to allow transfer, storage and statistical analysis of data, includingfacsimile machines, new computers, statistical software, photocopier and CD writer (for data backup), anddocument storage cabinets for patient and study records9. to establish a data safety monitoring board (DSMB)MethodsThis core will be led by Dr Matthew Law, who has 10 years of experience as head of the biostatistics department atNational 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 atHIV-NAT has commenced PhD training in NCHECR under the supervision Mathew Law. She will return to HIV-NAT tobe core leader following her training. Thirty plain paper facsimile machines will be installed at the study sites in Thailandand Cambodia and at HIV-NAT to facilitate data transfer. A license for SPSS software will be purchased. A DSMB willbe constituted, comprising members from Thailand, Cambodia and other countries, to be chaired by Scott Hammer,Professor of Medicine at Columbia University.
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