How can compliance with ICH E6 be ensured during remote monitoring?

Ensuring compliance with ICH E6 during remote monitoring primarily hinges on the establishment of clear procedures for communication and training. This approach is critical because effective communication and well-defined protocols ensure that all stakeholders involved in the clinical trial—including sponsors, monitors, and site staff—are aligned on processes, expectations, and standards.

Training is essential to equip the team with the knowledge necessary to follow ICH E6 guidelines and effectively utilize remote monitoring tools. When everyone understands their roles and the specific compliance requirements, it enhances data integrity, subject safety, and overall trial quality.

Moreover, clear communication procedures help in documenting remote monitoring activities, facilitating discussions around trial progress, addressing concerns promptly, and maintaining compliance with regulatory expectations, even when face-to-face interactions are limited. This structured approach fosters transparency and accountability, which are vital elements of adherence to ICH E6.

The other approaches do not provide the same level of assurance in compliance with ICH E6. Reducing participant contact can lead to gaps in data collection and oversight, while relying solely on automated data collection may overlook the complexities of human interactions and judgment inherent in clinical trials. Lastly, avoiding documentation of communications directly contradicts the principles of compliance, as thorough documentation is crucial for tracking adherence to protocols