The names, titles, degrees, addresses, and affiliations of all responsible parties, including at least the principal investigator and all co-investigators, and a list of all collaborating primary and other relevant institutions and study sites. An abstract of the protocol. The proposed study tasks, milestones, and timeline. F. A statement of research objectives, specific aims, and rationale. Research objectives describe the kinds of knowledge or information to be gained from the study.
Specific aims list the measurements to be made, and any hypotheses to be tested.
The protocol must distinguish between a priori research hypotheses and ones that have been based on knowledge of the data. The rationale explains how achievement of the specific aims will further the research objectives. A critical review of the literature to evaluate relevant variables and gaps in knowledge. For example, the literature review should be of sufficient depth to identify potential confounders and effect modifiers and to determine areas where new knowledge is needed. The literature review might encompass relevant animal and human experiments, clinical studies, vital statistics, and previous epidemiologic studies.