Showing results for "NCT03411733%20enrollment%20data%20site:clinicaltrials.gov"

Revised Biosafety Guidelines for Research with Gene Drive Modified Organisms
Introduction In the evolving landscape of biosafety research, the National Institutes of Health (NIH) has taken proactive steps to address the unique...
Navigating the Accelerated Approval Withdrawal Process: A Clear Path for Sponsors
Introduction The FDA’s draft guidance Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics proposes an accelerate...
What CITI Program is Reading - November 1, 2023
"What CITI Program is Reading" is our biweekly blog series which highlights news articles curated by our staff and relevant to research, higher educat...
New DOD Efforts to Combat Undue Foreign Influence in Higher Ed
The Department of Defense (DoD) has recently taken significant steps to address the issue of unwanted foreign influence on DOD-funded research at inst...
Updated Guidelines for Reporting Incidents to OHRP
The HHS Office for Human Research Protections (OHRP) issued an updated guidance, titled Reporting Incidents to OHRP (2022) to replace 2011's Guidance...
FDA Draft Guidance on Protocol Deviations in Clinical Trials
The FDA recently issued draft guidance titled “FDA Guidance on Protocol Deviations,” which provides critical insights into managing protocol devia...
Navigating the NIH's Notice to Fund Bioethics Research
Introduction The National Institutes of Health (NIH) Office of Science Policy (OSP) has unveiled a Notice of Special Interest (NOSI) for Administrati...
What CITI Program is Reading - February 22, 2022
"What CITI Program is Reading" is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher educatio...
Upholding Scientific Integrity: A New Policy from the NIH
The National Institutes of Health (NIH) has released a comprehensive Scientific Integrity Policy to safeguard the integrity of scientific research con...
OLAW Requests Input on Flexibilities Available to IACUCs for Program Review
The NIH Office of Laboratory Animal Welfare (OLAW) is seeking public input on flexibilities that IACUCs may consider when conducting semiannual progra...
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