A study protocol provides a detailed plan, outlining the objectives, methodology, and rationale of the research, ensuring the study is well-structured and scientifically valid.
The protocol specifies who will be included in the study (inclusion/exclusion criteria), helping ensure the results are relevant and applicable to the target population.
Study protocols must include procedures for obtaining informed consent and outline how ethical concerns will be addressed to protect participants' rights and safety.
Predefining the statistical analysis plan ensures that data is analyzed in a predetermined and unbiased manner, preventing manipulation of results.
Randomization helps ensure that the study groups are comparable, reducing selection bias and increasing the validity of the findings.
