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

For a randomized trial, what is essential to be documented in the study protocol?

1. Participant demographic information

2. Development of treatment plans

3. Description of procedures and treatment assessments

4. Safety concerns only

The correct answer is: Description of procedures and treatment assessments

In a randomized trial, documenting the description of procedures and treatment assessments in the study protocol is crucial because it provides a clear, detailed plan of how the study will be conducted. This documentation serves multiple purposes: 1. **Standardization**: It ensures that all participants receive the same treatment and that data collection methods are consistent across the trial, which is vital for maintaining the integrity of the study and minimizing bias. 2. **Reproducibility**: A well-documented protocol allows other researchers to replicate the study in the future, an essential component of scientific inquiry that validates findings. 3. **Regulatory Compliance**: Detailed descriptions of procedures and assessments are often required by regulatory agencies to ensure the trial adheres to ethical and scientific standards. 4. **Safety Monitoring**: While safety concerns are important and should be included in the protocol, they are part of the broader context of procedures and assessments, which also encompass the methodology and how outcomes will be evaluated. Including all aspects of how the study is designed and executed enhances clarity and ensures that all parties involved—researchers, sponsors, and ethics committees—understand the study's framework, increasing the overall credibility and reliability of the trial.