Protocol Development and Preparation for a Clinical Trial
A protocol is the most critical document in a research study. It plays a central role in the conduct of a study by describing how a hypothesis will be tested. It provides the necessary guidance and serves as the main reference for all study personnel, while also providing for the welfare and safety of all study participants; it must be prospective, detailed, and comprehensive. A protocol is organized in chronological divisions; the background and rationale provide the first impression of the investigators; study endpoints, especially the primary ones, drive the rest of the study design. The study population, methodological details, schedule of visits/procedures, and methods for ensuring patient safety must be described in detail, along with the study organization, administration, and anticipated results and significance. A high-quality protocol will more likely lead to a valid conclusion, whether it confirms or refutes the hypothesis, thereby reducing the likelihood of needing a costly repeat study.
KeywordsStudy Endpoint Case Report Form Baseline Visit Final Visit Study Personnel
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