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How can FDA protect human subjects following the discovery of clinical investigator misconduct?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Initiation of an enforcement action in federal court or a disqualification proceeding does not by itself halt an investigator's participation in clinical trials. Until an investigator is disqualified by FDA, the investigator remains free to participate in ongoing and new clinical investigations. There are, however, instances in which the investigator's misconduct appears to pose an ongoing risk to the safety and welfare of the human subjects under the care of that investigator. For example, where an investigator is found to have failed to monitor subjects for signs of serious toxicity associated with the experimental therapy, or falsified eligibility data, FDA may conclude that subjects under that investigator's care are at risk. Under such circumstances, protection of subjects may demand a more rapid intervention than would be offered by an enforcement action or a disqualification proceeding. As discussed above, an effective means of acting promptly to protect human subjects after the discovery of serious investigator misconduct is to impose a clinical hold on those studies or study sites involving the investigator.

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