Office of Clinical and Regulatory Affairs
The mission of NCCIH is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. In support of this mission, NCCIH funds a varied portfolio of grants, including randomized clinical trials and observational and epidemiological studies, with the goal of better understanding of “real world” patterns and outcomes of complementary and integrative health interventions and their integration into health care and health promotion.
In view of the diversity of complementary and integrative health interventions, clinical studies often require creative research designs and approaches that draw on the experience of distinct fields of biomedical and behavioral research studying procedural interventions, behavior change, or outcomes of health interventions in real world or practice-based populations. With such a varied clinical research portfolio studying the safety and potential application of complementary and integrative health interventions, the Office of Clinical and Regulatory Affairs (OCRA), part of the NCCIH Office of the Director, serves as a resource for the planning, implementation, and oversight of clinical research funded by NCCIH.
As NCCIH’s primary goals in the oversight of clinical research include minimizing risk to research participants; maximizing the success, scientific potential, and impact of funded work; and maximizing productivity and relevance of its programs, OCRA staff work with other NCCIH staff and study teams to ensure goals are achieved.
Prior to initiating clinical projects, OCRA staff facilitates finalizing study designs, analytic plans, and clinical study documents. The NCCIH Clinical Research Toolbox provides a Web-based information repository for investigators and staff involved in NCCIH-funded clinical research. The Toolbox contains templates, sample forms, and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies. Additional resources are also available for studies that are incorporated into the NCCIH site monitoring program.
After studies are initiated, OCRA staff facilitates ongoing communication between study teams and NCCIH staff, and regularly obtains reports from active clinical studies regarding participant accrual, as well as data and safety monitoring. The NCCIH Clinical Research Toolbox also provides several important resources for investigators with ongoing clinical investigations.