Trial monitoring and assurance

Monitoring focuses on the day-to-day oversight, ensuring protocol adherence, data integrity, and participant safety. Assurance encompasses the broader activities, including quality assurance and quality control, to ensure the trial’s overall quality and compliance with regulatory standards. Together, these processes help protect participants, ensure reliable and accurate data, and support the ethical and scientific integrity of clinical research.

There are a number of trial monitoring and assurance activities the trial team are to adhere to while running a clinical trial. They are:

Document and report protocol deviations and breaches

• Protocol deviations do not need to be immediately notified to the Human Research Ethics Committee (HREC), unless they meet the definition of a serious breach, in which they should then be reported to the HREC in a timely manner. Ensure you keep a log of all protocol deviations.
• Data breaches will need to be assessed for severity and impact in line with the Privacy Act. Check with your organisation as to how and to whom these should be reported.

Safety monitoring and reporting

• Review, maintain and follow the safety monitoring plan, which should have been written during the trial planning stage.
• The Principal Investigator (PI) at specific sites is responsible to assess and report:

Preparing for audit

• Notify trial personnel and make sure they are available on the date and time of the audit.
• Book a private room for the auditor to work in.
• Assign a person to assist in preparation for the audit and for the actual audit itself.
• Perform a comprehensive revision of the clinical trial documentation.
• Make any corrective action in response to the comprehensive revision.

Quality assurance

• Ensure the trial is being conducted to the SOPs and protocol
• If the Sponsor has established a Data Safety Monitoring Board, provide information to the Board when requested.
• Principal Investigator provides guidance and mentorship on responsible clinical trial conduct to the trial team and promotes education and training in responsible trial conduct complying with laws and guidelines.