Centralized facilities and common processes have proven to improve the feasibility, efficiency and quality of complex studies or studies implemented within difficult environments. These centralized approaches permit more rapid translation of laboratory studies into clinical and public health applications. A major strength of this application is a truly multidisciplinary approach to better understand the entire spectrum of time-dependent events taking place natural history of HIV-associated cervical cancer in a very time- and cost-effective manner by leveraging the unique characteristics of three populations of patients. Our proposed strategy is highly innovative and unique but requires high level of coordination and harmonization of processes across disciplines, research projects and populations. Thus, the overall objective of this Core is to reconcile the needs and research approaches of all disciplines involved, in order to assure high-quality, uniform processes and tools for data and specimens collection. The Shared Resources Core will be directed by Drs Zetola (UPenn) and Chilisa (UB) who have a very extensive and successful track record designing and implementing large research studies of multiple designs in developed and developing countries, dealing with highly vulnerable populations and have received research funds from NIH and other international organizations. The SRC will be responsible for all field work, as well as data and human sample collection for this application. The core consists of staff, facilities and/or laboratories which are available to all investigators and proposed projects. These resources provide support for basic scientific research, clinical research and projects within the public health sciences. In specific, we: 1) We will design, implement and maintain the three prospective observational cohorts of Botswana women that will produce the data and specimens for this application's research projects. Each of these cohorts has unique features that will allow the study of early, intermediate and late events in the natural history of HPV-associated cervical cancer in HIV-infected women;2) We will provide researches with a diverse array of biological specimens from subjects who are well characterized in terms of clinical, behavioural, and epidemiologic parameters. A central focus of this Core is managing and maintaining the entire spectrum of study-related human specimens;and, 3) Will coordinate data management and data sharing activities, as well as administrative and communication tasks. In addition, the SRC will assure compliance with Good Clinical Practices, establish standards for study coordination, and billing compliance. The shared Resources Core will serves as a link between the existing monitoring, training and mentoring programs and will provide an evidence-based approach to efficient use of both resources. We will gather and report up-to-date information on a real-time basis related to the research management of all projects. Routine, periodic reports will be provided not only to support the management of the daily CRS operations, but also many Cores proposed program as well as reporting to our stakeholders and funding agencies.
The objective of this Core is to reconcile the needs and research approaches of all research projects, in order to ensure high-quality, uniform processes and tools for data and specimen collection. We will manage common resources available to investigators to support their projects, simplify and fully standardize processes across cohorts and projects while working with the Administrative Core to ensure full regulatory compliance.
|Kempkes, Bettina; Robertson, Erle S (2015) Epstein-Barr virus latency: current and future perspectives. Curr Opin Virol 14:138-44|