NIAMS POLICY: REQUEST FOR A PLANNING PHASE IN CLINICAL TRIAL APPLICATIONS Release Date: November 8, 2000 NOTICE: AR-01-002 National Institute of Arthritis and Musculoskeletal and Skin Diseases Complex or large-scale clinical research requires extensive planning. A clinical trial requires detailed information on the study design, protocols and procedures, analytical techniques, identification of facilities, and organization of an effective group of investigators with an effective administrative plan. The clinical trial research plan is best presented in an organized and detailed Manual of Operations and Procedures (MOOP) that is submitted prior to initiation of the clinical trial. NIAMS is cognizant of the time and expense required for preparation of these documents. The design and implementation of successful clinical trials can be hampered by the lack of refined outcome measures, difficulties with recruitment of patients with rare diseases, and lack of information about standardization of procedures among participating clinics. The NIAMS planning period will also provide an opportunity to support these activities. All NIAMS grantees who intend to conduct a clinical trial are encouraged to budget a planning phase (up to 9 months) in their application, or be aware that NIAMS may restrict/withhold funds and require re-budgeting for pre- enrollment activities required to help ensure the quality of trial conduct. NIAMS will provide appropriate financial support to its grantees during the planning period in order to facilitate the development of documents containing detailed procedures and approvals for conducting clinical research, including the following: o Develop a detailed safety and monitoring plan o Develop a Manual of Operations and Procedures (MOOP), including the clinical protocol, a recruitment plan, case report forms, a data management system, etc. o Seek IRB approval of consent form(s) and protocol o Obtain project assurances via the Office of Human Research Protections o Resolve any IND issues with the FDA o Develop a database for study data storage o Train clinical site staff, develop study management tools o Organize an independent data and safety monitoring board (DSMB) The remaining funds will be released/awarded to the grantee upon approval of the procedures and documents listed above. The designated NIAMS Program Director will approve commencement of the clinical trial once all requirements have been met. Inquiries regarding clinical issues should be directed to: Christine L. Densmore Clinical Coordinator, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Disease 45 Center Drive, Rm 5AS-19B Bethesda, MD 20892-6500 (301) 594-5052 (voice) (301) 480-4543 (fax) densmorc@mail.nih.gov or Joanne Odenkirchen Clinical Coordinator, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Disease 45 Center Drive, Rm 5AS-37C Bethesda, MD 20892-6500 (301) 594-5055 (voice) (301) 480-4543 (fax) jo21x@nih.gov
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