Tag Archives: Clinical trials

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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Change in F&A Rate for Clinical Trials Effective 4/1/2021

The below message was sent on behalf of Dr. Robert Nobles, Vice President for Research Administration: March 12, 2021 Dear Colleagues, I am writing to share the outcome of an extensive review of our clinical trial definition and Facilities and Administrative Rate (F&A) rate. Over several months, we organized a working group that included faculty, […]

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TRANSITION OF NIH INCLUSION MANAGEMENT SYSTEM TO NEW HUMAN SUBJECTS SYSTEM (LIVE 6/8/18)

The National Institutes of Health has recently announced that it will replace the current Inclusion Management System (IMS) which is used to report the sex/gender, race, and ethnicity of participants in human subjects research studies. The new system will be the Human Subjects System (HSS). The HSS will consolidate human subjects and clinical trial information […]

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New Requirements for ClinicalTrials.gov

  Click here to learn about the new requirements for ClinicalTrials.gov.  

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New Requirements for Clinical Trials

March 29 Memo Regarding New Requirements for ClinicalTrials.gov

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New ClinicalTrials.gov FDA regulation and NIH policy

Written by: Jennifer Prozonic Office for Clinical Research  Changes and Impact of FDA Final Rule & NIH Policy for ClinicalTrials.gov In September of 2016, the U.S. Department of Health and Human Services issued a final rule expanding the scope of ClinicalTrials.gov and requiring additional registration and results reporting requirements to the existing Food and Drug […]

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