Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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Prepare for the ACRP Certified Professional Exam with our comprehensive quiz. Elevate your clinical research skills with targeted flashcards and multiple-choice questions. Enhance your readiness with detailed explanations and insights for improved performance!

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Is it necessary for a study protocol to include statistical analysis methods?

Yes, it is always required.
No, it does not need to include these methods.
Only for clinical trials with over 100 subjects.
Only for trials involving high-risk procedures.

The correct answer is: Yes, it is always required.

Including statistical analysis methods in a study protocol is essential because it provides a clear framework for how data will be handled, analyzed, and interpreted. This ensures the study is designed to achieve its objectives and that the results will be valid and reliable. Describing the statistical methods allows researchers to align their analysis with the study's goals and facilitates transparency and reproducibility. Moreover, having predefined statistical analysis methods is critical for mitigating biases and ensuring that results are not subjected to cherry-picking or post-hoc analyses, which could compromise the integrity of the findings. Regulatory bodies, ethical committees, and stakeholders often require this information to assess the robustness of the study design and to validate the appropriateness of the analysis. While there may be different requirements depending on the type or scale of the research, it is a fundamental aspect of developing a comprehensive and rigorously designed study protocol across most fields of research, particularly in clinical trials.