Tag: FDA
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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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The Revised Common Rule is Almost Here!
Effective January 21, 2019, human subjects research is subject to revised regulations. *Please note that FDA has not yet harmonized, so parts of the new Rule cannot be applied to FDA-regulated research.* Details are available in our recent webinars here: http://irb.emory.edu/Training/webinars.html. What will you see in eIRB? If you submit, or edit a new submission, after…
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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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Should Your Research Be Registered on ClinicalTrials.Gov?
If a research study meets any one of the following definitions, the trial must be registered on ClinicalTrials.gov: The Food and Drug Administration (FDA) requires registration for “applicable clinical trials” (ACTs) defined as follows: For any trials of drugs and biologics: controlled clinical investigations, other than Phase I investigations, of a product subject to FDA…