CLINICAL TRIALS NETWORK FOR FEMALE PELVIC FLOOR DISORDERS: ADDENDUM TO RFA-HD-00-013 Release Date: September 21, 2000 NOTICE: HD-00-009 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) On August 25, 2000, an Information Forum was held to address questions from potential applicants to RFA-HD-00-013, Clinical Trials Network for Female Pelvic Floor Disorders (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-00-013.html). This Notice presents a clarification of several issues raised at the Information Forum. A complete summary of questions and answers addressed at the Forum can be found at http://www.nichd.nih.gov/RFA/HD-00-013/HD-00-013.htm. Potential applicants are encouraged to contact staff listed below with any additional questions. CONCEPT PROTOCOLS FOR DATA COORDINATING CENTER APPLICATION Applications for the Data Coordinating Center must include a concept protocol. As stated in the RFA, the purpose of the concept protocol is to serve as an indicator of the applicant"s ability to participate in the development and design of protocols for cooperative clinical investigation. In addition to the concept protocol, applications for the Data Coordinating Center should include description of a plan for data collection from the Clinical Sites, data management, quality control, processing, analysis, and reporting. The concept protocol and the overall data management plan should be provided in the Research Plan portion of the PHS 398 application and are, together, subject to the 25 page limit. Applicants for the Data Coordinating Center should judge how much space to allocate to the concept protocol as well as the Network-wide plan for handling data, providing as much detail as page limits permit. FORMAT OF BUDGET Specific budget instructions for Clinical Sites and the Data Coordinating Center are included in the RFA. As noted in the RFA, since the project proposed in the application may not be adopted by the Network, the application budget should be viewed as a reasonable estimate for the purpose of review. Budget requests should be estimated as accurately as possible. Do not use the modular grant application format for the budget. Applications that use the modular format will be judged non-responsive to the RFA and will be returned to the applicant without review. For the purposes of estimating the budget in applications for Clinical Sites, assume that your proposed study will be carried out by the Network and that your site will be responsible for enrolling a proportion of subjects in that protocol. Based on anticipated enrollment from the pool of eligible subjects at your institution, estimate costs of performing that portion of the protocol at your site. For the purposes of estimating the budget in applications for the Data Coordinating Center, assume that three new protocols for randomized clinical trials will be initiated during the second phase of the study (the second six months of Year 01, and Years 02-05). Assume that the three studies plan to enroll 200 subjects in each study, with the collection of 1000 data points on each subject in each study. For applications for the Data Coordinating Center, the travel budget also should include travel for the number of personnel needed to carry out training of the Clinical Sites study coordinators and data entry clerks. Assume centralized training for one to two days to be held in the Washington, DC area annually during Years 01-05. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Anne M. Weber, M.D., M.S. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B13C, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6972 FAX: (301) 480-1972 E-mail: webera@mail.nih.gov Direct inquiries regarding fiscal matters to: Mr. Michael Loewe Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17J, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-7008 FAX: (301) 402-0915 E-mail: loewem@exchange.nih.gov


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