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 occurs during a clinical trial, proper responses include:
- Documenting the violation and any corrective actions taken
- Reporting the violation to the Institutional Review Board (IRB) 1
- Immediately addressing any participant safety concerns related to the violation
These steps ensure transparency, regulatory compliance, and participant protection. Reducing the sample size, however, would compromise the scientific validity and statistical power of the study, potentially invalidating the research findings. It also fails to address the root cause of the violation and could be seen as an attempt to hide problems rather than properly managing them. Protocol violations should be managed through improved training, enhanced monitoring procedures, or protocol amendments if necessary, while maintaining the integrity of the study design, as emphasized by the SPIRIT 2013 statement 1.
In the context of clinical trials, adherence to protocol is crucial for ensuring the reliability and generalizability of the results, and any deviations from the protocol should be handled in a way that prioritizes participant safety and the integrity of the study. The Heart Failure Association of the European Society of Cardiology also highlights the importance of adapting IRB policies to support clinical trials during extraordinary circumstances, such as the COVID-19 pandemic, while maintaining the principles of good clinical practice 1.
Therefore, the focus should be on addressing the protocol violation in a transparent and compliant manner, rather than altering the study design in a way that could compromise its validity.
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.