Episode 15 - Good Documentation Practice (GDP)

Intro to Clinical Research

Debbie and Elyse에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Debbie and Elyse 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.

1+ y ago 44:04

MP3•에피소드 홈

So it’s been 5 minutes since we talked about Debbie’s favourite topic documentation, so we’re back there to discuss Good Documentation Practice (GDP). What does that mean in real, clinical trial practice, what are some of the rules that need to be followed?

Here is the link to the FDA Warning letter sent to Amazon.com in December 2023 - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023

AND! Debbie finally found the name of the drug that began with a “K” = Ketek, and the fraudulent enrollment https://www.nejm.org/doi/full/10.1056/NEJMp078032#:~:text=The%20study%20was%20completed%20in,complete%20fabrication%20of%20patient%20enrollment.

Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

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#Science #Fitness #Biology #Podcasting Education #Medicine #Debbie and Elyse