Tag: compliance
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ClinicalTrials.gov Pre-Notice & Notice of Noncompliance
The Food and Drug Administration (FDA) is taking action to ensure certain information in ClinicalTrials.gov is available to the public. On April 28, 2021, the FDA issued its first notice of non-compliance for failing to submit required results information. A Notice of Noncompliance indicates that the FDA has determined the Responsible Party (Principal Investigator) was…
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Restructuring and Establishment of the New Research Compliance Office
On January 25, 2021, an announcement was released from the EVP for Business and Administration, Christopher Augostini, regarding the restructuring of the University Compliance Office and the establishment of a new Research Compliance Office. The announcement in its entirety, can be found here. After the retirement of the former leader of the Office of Compliance,…