After months/years of conducting your clinical trial, you submit a Premarket Approval Application (PMA) to the Food and Drug Administration (FDA) with the expectation that your Class III medical device will be approved. Unexpectedly, you receive a call from the FDA. The FDA requests to inspect one of your sites to ensure that the data is scientifically valid and the welfare of research subjects have been protected. You don’t worry. Later, the FDA issues a Warning Letter revealing serious violations that could jeopardize the validity of the trial and may refuse to approve the application. You then realize, all of this could have been prevented.
In the above scenario, this could be you; however there are strategies that you can follow to help avoid this. Clinical trial monitoring plays a significant role to achieving data integrity amongst clinical trials and the protections of research subjects. Data integrity issues can be addressed before a trial begins and can be identified and resolved during the trial, or at study closure. The key is being able to identify these issues and how to address them accordingly. To assure quality and integrity of your trial data, a systematic approach should be used:
Site Initiation
- Proper selection of sites and Clinical Investigators (CI) based on experience and achievement
- Ensure the CI and all those involved in the conduct of the trial are properly trained on the protocol, the applicable regulations, the device, drug or biologic, and the EDC system
- Ensure all those who are performing tasks are delegated that role
- Ensure the study has a monitoring plan, including qualified and trained monitors
Monitoring
- Ensure all research subjects enrolled in the study meet all study inclusion and no study exclusion
- Ensure informed consent is properly obtained according to the regulations, site policies, and IRB policies
- Ensure all data is legible, accurate, and attributable
- Perform product accountability and reconciliation if applicable
- Ensure all adverse events are being identified and reported accordingly
Study Closure
- Data cleanup and review the quality of all documents from the trial
What do you think about this topic; are there other strategies that you find important when ensuring data integrity? We would love to hear your thoughts!
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
