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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials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. The draft guidance also states that informed consent can be collected remotely or electronically as part of a DCT, so long as there is institutional review board oversight. 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 started pre-pandemic and very quickly it went to telehealth, so it was primarily telehealth. We put a couple extra things in place to really try to reschedule appointments, and this was telehealth.

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Anti-Asian Hate: Russell Jeung, Lingsheng Li, & Jessica Eng

GeriPal

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. Eric 14:41 You mentioned the study.

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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. Alex: We are delighted to welcome Joe Rotella, who’s the Chief Medical Officer of the American Academy of Hospice and Palliative Medicine. Now is the time to act, dear listeners! Eric: Yeah.