Title and Introduction: Provides an overview of the study, its significance, and the research questions it aims to address.
Objectives and Hypotheses: Clearly outlines the primary and secondary
objectives and the hypotheses to be tested.
Study Design: Describes the type of study, such as randomized controlled trial or observational study, and the rationale behind the chosen design.
Population and Sample Size: Details inclusion and exclusion criteria for participants, along with the sample size calculation to ensure statistical power.
Intervention and Control: Specifies the treatment or intervention being tested and the control or comparison group.
Endpoints: Defines primary and secondary endpoints that will measure the effectiveness and safety of the intervention.
Data Collection and Management: Describes methods for data collection, monitoring, and analysis, ensuring data integrity and security.
Ethical Considerations: Addresses informed consent, confidentiality, and the role of
Institutional Review Boards (IRBs).
Statistical Analysis: Outlines the statistical methods and tools to be used in analyzing the data.
Timeline and Milestones: Provides a schedule for the study, including key milestones and deadlines.
