NIA's Clinical Research Toolbox provides a study protocol template and manual of procedures for download and adaptation by study investigators. The study protocol template outlines a clinical trial protocol and provides guidance on important content to include in each section. The Manual of procedures facilitates consistency in protocol implementation and data collection across study participants and sites. The NIA Toolbox contains numerous other templates, sample forms, guidelines, regulations and information materials to assist investigators in the development and conduct of high quality clinical research studies.
From the National Institute on Aging (NIA) Clinical Research Study Investigator's Toolbox. http://www.nia.nih.gov/ResearchInformation/CTtoolbox
