Research Project
9111999
PROJECT SUMMARY (See instructions): The Administrative Core Objectives are to oversee and manage the research and preclinical and clinical development activities of the five projects. Dr. Regine Sitruk-Ware, who will direct the U54 Center and oversee the Core, has extensive experience in the management of clinical research and contraceptive research & development. The co-Director Dr Patricia Morris has considerable experience in managing laboratory work and scientific as well as technical staff. The core will support the production of periodical progress reports, will monitor expenditure for each project and contribute to the generation of financial reports. In addition, as several of the projects have a clinical component, work on preparing the Investigational New Drug (IND) Applications to the FDA and annual reports submissions, as well as reporting of the Serious Adverse Events that may occur during the clinical studies is a responsibility of the Population Council as IND holder. Audits of the batch production of study materials in the laboratories will be ensured for Quality Control to allow release of GMP clinical batches for clinical studies. Manuscripts and report writing, organization of meetings of the Advisory Board, will be ensured as well by the core. Decision making Process: The PD/PI and the co-Director will manage together the budgets for each project and make decisions on possible adjustments where needed in communication with the NICHD Program Manager. Cost-effectiveness: The PIs of each of the 5 projects will access the services of the Administrative Core and the Program Manager/ Grant coordinator and Staff Assistant will provide support according to priorities decided by the PD and co-D when needed. Regulatory support will also be provided to each project where a clinical component is included and planning will be organized with the project's PI. Such a small team of people with multiple skills will be cost-effective to support the overall administration of the U54 Center.
