In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when...

In investigator-initiated studies, the PI holds primary responsibility for addressing non-compliance, including root cause analysis and implementation of CAPA plans. This ensures that any issues affecting the study’s integrity are adequately addressed and prevented in the future.

The answer is verified based on ICH E6(R2) guidelines which emphasize the PI’s responsibility for maintaining compliance at the study site.

"The PI must develop and implement corrective and preventive actions when non-compliance is identified during the study."

Objectives:

Maintain compliance in investigator-initiated studies.

Address non-compliance through CAPA.