Episode 15 - Good Documentation Practice (GDP)

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 clinical.research.intro@gmail.com. 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/