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GCP versus ISO 14155 training

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  • Anon
    14/10/2020 15:30
    Dear All, I would like to get your opinion and/or advice about the following. As a CRO we are supporting both drug and medical device studies. In the past, investigators participating in device studies were trained in GCP. That was common practice. But with ISO 14155 and especially the new version released earlier this year, would you expect investigators, next to GCP, to be trained in this ISO standard as well or only in ISO 14155? Or can evidence of GCP still serve as sufficient evidence for researchers? In principle there is not much of a difference between both. You have plenty of providers offering GCP training but for ISO 14155 this is not common. Many thanks
  • Anon
    14/10/2020 19:45
    Hi, This is a really interesting question. We are a CRO specialising in device trials. Our staff is trained in GCP and also 14155 is a requirement on our training matrix. However, 14155 requirement is on a read/ review basis, unlike GCP course with a certificate with expected renewal schedule. We refer to the ISO standard in our documentation, so its awareness is important. I would not expect to see 14155 training in ISF, I think it is sufficient for investigators to have a documented knowledge of GCP. 14155 could be perhaps added to any investigator training, as a ppt, more for awareness/reference.
  • Juergen Kaetzler
    14/10/2020 20:26
    In general, ICH E6(R2) and ISO 14155 are similar; there are slight differences which are, in my opinion, only on a formal/minor level. From my point of view the ISO 14155 is more technical and in some parts more detailed than GCP. >> If a clinical trial on a medical device in GERMANY is conducted according the the German Medical Device Law, then investigator's need to provide a training certificate on ISO 14155 and relevant German legislation on medical devices. Therefore, ISO 14155 trainings exist in Germany. Many of them are designed as addon-trainings to GCP trainings. In other words: Investigators need to have GCP trainings as it is required for trials with medicinal products and in addition they need to have an ISO 14155 training. I guess this will not help you that much, but I can only share my experiences from medical device studies in Germany. >> I am unsure whether the EU Medical Device Regulation has some specific requirements included?
  • Anon
    16/10/2020 12:31
    Thanks a lot for the feedback!
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