What must be done if a deviation from the protocol occurs?

When a deviation from the protocol occurs in a clinical trial, the investigator must document and potentially report this deviation in accordance with Good Clinical Practice (GCP) guidelines. Proper documentation ensures that there is a record of what happened, including details of the deviation and its potential impact on the trial. Reporting the deviation is also crucial, as it may need to be communicated to the Institutional Review Board (IRB), regulatory authorities, or sponsors.

This systematic approach not only maintains the integrity of the clinical trial data but also helps to ensure patient safety and compliance with regulatory requirements. By documenting and reporting deviations, investigators and sponsors can effectively assess the implications of the deviation on the study results and participant safety, allowing for organizations to take corrective actions if necessary.

In contrast, minor deviations should not be ignored, as even small changes can affect the study's validity. Verbal communication alone is insufficient for maintaining a complete and accurate record. Creating a new protocol is unnecessary and impractical for addressing a deviation, as it can disrupt the study's continuity and may not be feasible in practice. Maintaining the original protocol while properly managing deviations is the best practice in clinical research.