What is the clinical research process?
• Initiation • Review and approval The Protocol Review Committee (PRC) is responsible for providing RTRN with a thorough scientific, ethical, and operational assessment of study concept plans and research protocols. A subgroup of the PRC reviews Concept Plans. Review criteria includes: 1) potential for improving health outcomes; 2) relevance to health disparities; 3) cultural appropriateness and relevance; and 4) the translational component. Protocol reviews will be conducted by the entire PRC because they are more detailed and involve evaluation of both the study design as well as the proposed operations. The PRC will ensure that study protocols are accurate, consistent, complete and, to the extent possible, standardized relative to other RTRN protocols. In reviewing project protocols, the PRC will assess available clinical research resources and expertise, DTCC resources, potential biomedical ancillary studies, feasibility of multi-site implementation, community level assessments, po
