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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law

Study visits can be conducted using telehealth visits if in-person interaction is not necessary. For example, the draft guidance notes that the trial’s data management plan should include information about the multiple sources of data collection. Trial personnel can also be sent to participant’s homes.

Clinic 59
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PC Trials at State of Science: Tom LeBlanc, Kate Courtright, & Corita Grudzen

GeriPal

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. We have our social workers and our psychologists and we know how to manage these symptoms. And that helped them focus on that instead of, say, the blood pressure, the vasopressors or the ventilator settings that day.

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Telemedicine in a Post-Pandemic World: Joe Rotella, Brooke Calton, Carly Zapata

GeriPal

This DEA is taking 6-months to consider how to move forward vis a vis restrictions and requirements for telehealth in a post-pandemic world. So we’re going to be talking about telemedicine, telehealth for people with serious illness. Brooke: So I think of telehealth as the umbrella. Now is the time to act, dear listeners!