Tag Archives: Clinical trials

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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