04/25/2023
Photo by Mark König on Unsplash
The US Food and Drug Administration (FDA) released a final questions and answers guidance document, “A Risk-Based Approach to Monitoring of Clinical Investigations” in April 2023. It includes recommendations for developing a monitoring approach and the content of the monitoring plan, and follow up and communication of the monitoring results. The questions and answers guidance is a companion to the “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” guidance from August 2013.
Sponsors are responsible for oversight of clinical trials. A system needs to be in place to ensure the quality of the trial, and to maintain data integrity and participant safety. The 2013 guidance describes that early in study design sponsors should identify the processes and data that are critical to data integrity and participant safety, building quality into the study design. Then risk assessment should be performed to establish if identified risks can be mitigated or if they can be managed through study oversight plans or monitoring plans. Important issues that are identified should be addressed and escalated as appropriate per the monitoring plan. After study start up, risk management should continue throughout the study.
The questions and answers guidance includes three topic areas and eight questions:
Monitoring Approach
What is the purpose of the risk assessment and should sponsors document their methodologies and activities for assessing risk?
Should sponsors monitor only risks that are important and identified during their initial risk assessment as likely to occur?
What factors should sponsors consider when determining the timing, types, frequency, and extent of monitoring activities?
How can a risk-based approach to monitoring that includes centralized monitoring help minimize missing data or protocol deviations?
Should the risk-based monitoring approach include processes to ensure that appropriate blinding is maintained?
Monitoring Plan Content
o What elements should sponsors include in monitoring plans?
Follow-Up and Communication of Monitoring Results
How should sponsors follow up on significant issues identified through monitoring, including communication of such issues?
How should monitoring activities and the results of these activities be documented and shared with those involved in the investigation?
The clinical research industry requires integration of a quality risk management approach to increase participant safety and data integrity, while also promoting working smarter to support project cost containment and affordability. This is a time for stakeholders to have efficient clinical quality management systems to support this balance between safety, cost, timeliness, compliance, and more. Clinical Pathways supports sponsors, CROs, and sites to identify gaps and implement changes. Let our consulting experts help your organization proactively prepare. Contact us at info@clinicalpathwaysresearch.com for more information.
- The Clinical Pathways Team
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