From the Guidelines
The correct answer is C, as reducing the study sample size in order to minimize future protocol violations is not an appropriate response to a protocol violation occurrence. When a protocol violation happens during a clinical trial, proper responses include:
- Documenting the violation along with any corrective actions taken
- Reporting the violation to the Institutional Review Board (IRB) that oversees the study, as emphasized by the importance of IRB policies in adapting to extraordinary circumstances such as the COVID-19 pandemic 1
- Immediately addressing any participant safety concerns related to the violation
Reducing the sample size is inappropriate because it compromises the scientific integrity and statistical power of the study, potentially invalidating the research findings. Additionally, reducing sample size doesn't actually address the root cause of the violation or prevent similar issues in the future. Instead, protocol violations should trigger a thorough review of procedures, additional training for staff if needed, and implementation of preventive measures while maintaining the study's scientific validity and participant safety. The SPIRIT 2013 Statement provides a guideline for the minimum content of a clinical trial protocol, emphasizing the importance of a well-written protocol in facilitating an appropriate assessment of scientific, ethical, and safety issues before a trial begins 1.
In the context of clinical trials, maintaining the study's scientific validity and participant safety is crucial, and reducing the sample size does not align with these goals. Therefore, option C is the correct answer, as it is not an appropriate response to a protocol violation occurrence.
From the Research
Protocol Violation Response
The following options are potential responses to a protocol violation occurrence:
- Document the violation and corrective action
- Report the violation to the affiliated IRB
- Immediately address any concerns regarding participant safety related to the violation
Inappropriate Response
The option that is NOT an appropriate response to a protocol violation occurrence is:
- Reduce the study sample size in order to minimize future protocol violations
There are no research papers provided that directly address the appropriate response to a protocol violation occurrence in the context of GCP certification 2, 3, 4, 5, 6.