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FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors
Manage episode 379616650 series 1533910
Content provided by K&L Gates LLP and L Gates. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by K&L Gates LLP and L Gates or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.
100 episodes
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Manage episode 379616650 series 1533910
Content provided by K&L Gates LLP and L Gates. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by K&L Gates LLP and L Gates or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.
100 episodes
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Similar to K&L Gates Health Care Triage
It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
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