Episode 58 - Interpretation of ICH GCP part 1

This is part 2 of our discussion on interpretation of GCP. If you haven’t listened to part 1, I recommend going and checking that out first. We’re covering a few more examples where ICH GCP sets out the principles and practices that should be followed to have harmonised, quality research.  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/

Today, we’re finally getting into why Debbie says “it depends” so much in answer to many of Elyse’s questions. We’re looking at how ICH GCP sets out the principles and practices that should be followed to have harmonised, quality research. This is part 1, so stay tuned for part 2 following soon!  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/

Today, Debbie throws us all back into the Philosophy Ravine together to discuss medical ethics. We’re going to talk about what it is and use the framework of Medical Ethics to consider two case studies - the Minnesota Starvation Experiments and Covid-19 Challenge Studies. Content Warning - this podcast does discuss WW2, and experiments where patients chose to restrict their access to food.  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/ References -  https://www.bmj.com/content/371/bmj.m4258#:~:text=In%20the%20current%20pandemic%2C%20over%2038%20000,a%20non%2Dprofit%20organisation%20advocating%20for%20these%20volunteers https://www.bbc.co.uk/news/health-56097088#:~:text=Getty%20Images,more%20than%2015%20million%20people.  https://www.pushkin.fm/podcasts/revisionist-history/the-rise-of-the-guinea-pigs  https://thispodcastwillkillyou.com/2025/10/14/episode-190-starvation-more-than-hunger/  Firsthand: The Minnesota semi-starvation experiment, University Publications, Archives & Special Collections, Colorado State University https://hdl.handle.net/10217/02.0036381

In this episode, we’re going to be discussing some international collaborations in clinical research! Let’s cross some borders and work together! 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/ References -  https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/opening-procedures-ema-non-eu-authorities-open-framework  Who Guidance for Best Practice on Clinical Trials - https://iris.who.int/server/api/core/bitstreams/dbe6d97c-b659-4e7b-8070-b4a3c667d6e5/content  https://picscheme.org/en/about

Hey everyone! We’re back (again!) and we hope you didn’t miss us too much. In this episode, we’re going to be discussing safety events, safety reporting and the compilation of information in the Investigator’s Brochure.  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/

Hey everyone! We’re back and we hope you didn’t miss us too much. In this episode, we’re diving right back in and talking about Medical Devices - what they are, how varied they can be, and how they’re regulated (in general terms!)  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/   References  https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices  https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices  https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents  https://www.fda.gov/media/82395/download  https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements  https://hollandhoudek.com/implants 

In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about Anthrax, and Anthrax vaccines. Maybe you know as little about it as Debbie, or maybe you know loads, but as always, Elyse is going to guide us through this topic from her goblin corner! 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/ References https://www.ncbi.nlm.nih.gov/books/NBK220522/  https://www.cdc.gov/anthrax/prevention/index.html  https://blogs.cdc.gov/niosh-science-blog/2022/04/21/welders-anthrax/  https://www.cnn.com/2024/05/05/us/how-it-really-happened-anthrax-attacks  https://pmc.ncbi.nlm.nih.gov/articles/PMC7993152/  https://journalofethics.ama-assn.org/article/informed-consent-military-anthrax-vaccination-case/2007-10  https://www.fbi.gov/history/famous-cases/amerithrax-or-anthrax-investigation  https://www.sciencedirect.com/science/article/abs/pii/S0264410X22010453  https://pmc.ncbi.nlm.nih.gov/articles/PMC6147967/  https://ajph.aphapublications.org/doi/full/10.2105/AJPH.92.5.715  https://clearinghouse.net/doc/40458/  https://web.archive.org/web/20171114165441/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474027.htm  https://web.archive.org/web/20171114200815/https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMRegulatoryScience/ucm391665.htm  https://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax   

In this episode, we’re talking about Data Management because of a listener question - thanks very much Aswini! So, we get into the weeds about the data that is collected as part of a clinical trial and what is done with it - including what “data cleaning” really is! 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/

Today, we’re going to discuss Good Manufacturing Practice - GMP - which is like GCP but for the manufacturing of drugs, devices, food and cosmetics rather than the clinical processes involved in research.  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/ References - https://database.ich.org/sites/default/files/Q7%20Guideline.pdf https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice https://pmc.ncbi.nlm.nih.gov/articles/PMC7395820/  Maintenance Phase Episode - https://open.spotify.com/episode/2iqRW5kzS02w4HRi6vOi6Q 

Wow, 50 episodes of our podcast. How exciting. So, in celebration, I’ve collected together some out-takes and previously un-released material (un-released, in that, we recorded it and I edited it out of the main episode, often for a good reason!) So you have a real mixed bag selection of Debbie stumbling over words, lots of laughter, reading emails out loud to Elyse, and us talking about how to survive the Skull Cave in Stardew Valley, plus so much more.  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/