The National Eye Institute (NEI) supports large-scale clinical vision research projects, including randomized clinical trials and epidemiologic studies. At the time of submission, applications requesting support for these activities are expected to provide detailed information regarding the study rationale, design, analytic techniques, protocols and procedures, facilities and environment, organizational structure, and collaborative arrangements. This information is best conveyed in a well-documented Manual of Procedures (MOP), the development of which represents a costly and time-consuming activity. This FOA is designed to facilitate activities central to the refinement of a study protocol and procedures and the development of a detailed MOP. The NEI Clinical Study Planning Grant may be used to support the development of a MOP, as well as to conduct preliminary studies to refine study procedures or document recruitment potential. The grant must not be used to generate data on the effects of a proposed intervention. This NEI FOA is applicable to both epidemiologic and clinical trial research studies.
