• Episode 54 - Medical Devices
    Dec 22 2025

    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 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/

    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

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    49 mins
  • Episode 53 - Elyse's Corner: Anthrax Vaccines
    Oct 6 2025

    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 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/

    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

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    57 mins
  • Episode 52 - Data Management
    Sep 22 2025

    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 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/

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    1 hr
  • Episode 51 - Good Manufacturing Practice (GMP)
    Sep 8 2025

    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 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/

    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

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    52 mins
  • Episode 50 - Out-takes and unreleased stuff
    Aug 25 2025

    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 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/

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    29 mins
  • Episode 49 - Patient Reported Outcomes
    Aug 11 2025

    Today, we’re discussing patient reported outcomes - what are they, how can they be measured and how do they compare to other measures we often use to measure the success (or not) of research.

    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/

    References

    https://www.jmir.org/2020/3/e12689/

    https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-18#:~:text=A%20patient%2Dreported%20outcome%20(PRO,(Powers%20et%20al%202017).

    https://www.gov.uk/guidance/patient-reported-outcomes-and-experiences-study#:~:text=Broadly%2C%20PROMs%20evaluate%20either%20the,pain%20or%20discomfort

    https://www.birmingham.ac.uk/research/centres-institutes/patient-reported-outcomes/prolearn/pros-in-trials#:~:text=Capturing%20Patient%2DReported%20Outcomes%20(PROs,and%20treatment%20on%20their%20life.

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims

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    56 mins
  • Episode 48 - Site Monitoring, part 2
    Jul 28 2025

    In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! This is part two (so go back and listen to part 1 if you haven't already), where we look at the detail of the things the monitor gets up to whilst on site (aka at the hospital or clinic) that we didn't cover in Ep 1.

    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/

    References

    ICH GCP E6 R3

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    1 hr
  • Episode 47 - Site Monitoring, part 1
    Jul 14 2025

    In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! This is part one (part two will be released in a couple of weeks), where we introduce the concept of monitoring and get into the detail of some of the things the monitor gets up to whilst on site (aka at the hospital or clinic).

    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/

    References

    ICH GCP E6 R3

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    55 mins