FREE SOCRA CCRP Study Protocols Questions and Answers
What is the primary purpose of a study protocol?
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.
In a randomized controlled trial (RCT) study protocol, what is the purpose of randomization?
Randomization helps ensure that the study groups are comparable, reducing selection bias and increasing the validity of the findings.
What key element is typically included in a study protocol?
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.
Why is it important to predefine the statistical analysis plan in the study protocol?
Predefining the statistical analysis plan ensures that data is analyzed in a predetermined and unbiased manner, preventing manipulation of results.
Which of the following is a common part of a clinical trial study protocol?
Study protocols must include procedures for obtaining informed consent and outline how ethical concerns will be addressed to protect participants' rights and safety.