What document provides details about the objectives and design of a clinical trial?

The correct answer is the protocol, which is a comprehensive document that outlines the objectives, design, methodology, statistical considerations, and organization of the clinical trial. It serves as a guide for all aspects of the trial, providing clear details on how the study will be conducted, including subject recruitment, interventions, assessments, and data analysis. The protocol ensures that there is a standardized approach to conducting the trial, facilitating compliance with regulatory requirements and maintaining the consistency and integrity of the research.

While the investigator's brochure contains essential information about the drug or device being tested and is a resource for investigators, it does not provide the complete framework for the trial itself. Standard operating procedures are guidelines for processes and practices within the clinical trial process but do not specifically outline the study's objectives or design. Source data refers to the original records or documents where data generated during the trial are noted, but it does not describe the trial's full design or objectives. The protocol provides all necessary details to ensure that the trial is conducted according to plan, making it the essential document in this context.