The administrative core will support the work of the projects and reduce duplication of effort by providing a centralized administrative service that serves all the projects. The Administrative Core will draw on the experience and infrastructure of the Perinatal HIV Research Unit and the partner organizations in accomplishing these goals. The Administrative core will be responsible for the governance of the program and communications between projects and will provide the support services for regulatory and study monitoring, central pharmacy and financial management. In addition, a data management center will be established for the projects that will utilize Datafax technology compatible with that used in both the HPTN and HVTN. The development of this data management capacity will be extremely valuable for the projects covered in this application and will provide capacity that can be utilized in future work in the country. The administrative core will also provide statistical services for the projects and will actively train South Africans in this under resourced field in the country.
The specific aims of the Administrative Core are: 1. To define the quality management plan and train all investigators, 2. To ensure quality management is implemented in the projects and cores of the program, 3. To ensure close internal and external monitoring of serious adverse events and toxicity, 4. To establish frequent and effective communication systems between components, 5. To provide statistical and data management support for the projects 6. To submit projects for regulatory review and institutional review 7. To implement effective quality assurance and control 8. To provide a central pharmacy function 9. To provide financial management for the program 10. To review and maintain the ongoing scientific agenda and ensure the progress of CIPRA grant. 11. To conduct health economics and pharmacoeconomic analyses for the projects.
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