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

FDA's New AI/ML Device Regulation Action Plan
On 12 January 2021, the FDA announced a five-part action plan creating a framework which would enable FDA to further their oversight as well as provid...
What CITI Program is Reading - October 30, 2024
"What CITI Program is Reading" is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher educatio...
Nothing Basic About It, But We’ll Try to Make It So – Common Rule ABCs with OHRP
This webinar reviews why we have regulations to protect research participants, how they function, and who needs to comply with them. The webinar is in...
What is Research and What it isn't? And Who is a Human Subject Anyway? – Explaining the Common Rule in Plain Language
This webinar explains when an activity is or is not considered research, and who is or is not a human subject according to the Common Rule. The webina...
The ABCs of 104: Understanding Exemption Categories
This webinar explains what it means to be exempt from the Common Rule, conditions for the different exemption categories, and when human subjects rese...
Doing Research with Data and Biospecimens Under the Common Rule Part 1 - What Researchers Should Know
In this part 1 of a two-part set of webinars, learners will explore what researchers should know about biospecimens under the Common Rule. Note: Th...
Doing Research with Data and Biospecimens Under the Common Rule Part 2 – How Does that Work with Repositories and Future Use?
In part 2 of Doing Research with Data and Biospecimens Under the Common Rule, learners review how the Common Rule specifically applies to research rep...
Before Saying “I Do” to the Common Rule: Figuring out “Engagement”
“Engagement” under the Common Rule often presents challenges to institutions and IRB administrators. This webinar takes a deep dive into the conce...
Respecting Persons – From Basic Requirements to Embracing Participant-Centered Informed Consent
This webinar reviews ethical principles, discusses regulatory requirements for informed consent, and offers strategies to develop high-quality, partic...
The Who, What, Why, and Where of IRB Meetings and Membership
This webinar provides an overview of the requirements for Institutional Review Board (IRB) meetings and membership, including quorum, minutes, records...
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