A Structural Characterization of Clinical Research Participants and Their Activities

Designed primarily as a reference tool, this report summarizes information about clinical research activities gathered through (1) discussions with clinical investigators and other clinical research personnel at institutions, (2) a formal survey, and (3) the literature. Information is presented in a highly structured framework which emphasizes, generally from the investigator's viewpoint, interactions among the people, institutions, and inanimate entities that participate in clinical research. Interactions are explicated during the research study as it progresses through three stages of development and nine activities: protocol generation (development of potential research ideas, development of a research plan, development of a written proposed protocol, approval of a protocol); protocol execution (development of a working protocol, generation of subject-specific protocols and admission of subjects, execution of a protocol and collection of data); and analysis (analysis of experimental results, publication of reports).