In this initial step, a researcher determines a topic to study by examining current research studies, determining the public health need, and making sure the topic supports the mission of the study sponsor.
After determining a topic or research question to study, the researcher puts the study question into a context and provides the evidence for posing the study question. This evidence may be from literature review or review of other data. The researcher then analyzes the difference between what knowledge or data currently exist about the topic and what the proposed study will answer.
After the concept for the study is framed by the researcher, he or she requests a review of that concept. Experts in the field or colleagues may review the concept and provide feedback.
After reviewing and incorporating the feedback from reviewers, the researcher prepares the "concept document." This concept document is included in the application for funding from a sponsor group, organization, or agency.
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