Intro to Clinical Research

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/