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Thread: eSOURCE Vendors /Systems

  1. #1

    eSOURCE Vendors /Systems

    Hi all,

    I've been reading with a great deal of interest about eSOURCE dedicated systems. These are separate from a hospital or primary care based EHR system. There are a few around like REALtime, Florence, and CRIO eSOURCE, but all of these are US based companies. CRIO does comply with EU Annex 11, GDPR etc.

    There hasn't really been a lot of conversation about these types of software solutions here in the UK, and it would be useful to have some guidance on their utilisation. They certainly tick boxes for ALCOA +. We'd very much like to cut back on paper, whilst also improving data quality.

    Any advice around these (and not EHR like EMIS, SYstemOne, OCEANO etc) would be gratefully received.

    Bw

    PR

    (I've copied this across from my post on the GCP thread, this appears to be a better thread and fit, but I don't appear to be able to edit the original post to remove it)

  2. #2
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    I hope others can reply. You probably already know about the EMA IWG webpage that has some good Q & As on similar topics and also the EMA statement on CSV. Just for interest.
    https://www.ema.europa.eu/en/human-r...l-practice-gcp

    https://www.ema.europa.eu/en/documen...-trials_en.pdf

  3. #3
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    Ditto above. Basically you need to be able to demonstrate confidence the system is fit for purpose (validation). Ideally the hospital etc would be able to provide evidence of this as part of their validation efforts (procurement due diligence etc). if they cannot provide this, you should do something yourself. In the absence of any evidence you are going to have to make a difficult (and probably cost) judgement, but you would have to provide *some* validation evidence for your specific use case, e.g. pragmatic testing.
    You might also make a judgement re. 21CFR p11 equivalence with EU Annex 11 - there are various papers available to assist. Any data protection issues associated with US hosting must surely have been adequately addressed by the hospital before use.

  4. #4
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    Don't forget the EMA draft guidance on - Guideline on computerised systems and electronic data in clinical trials. Lots of good information.
    https://www.ema.europa.eu/en/documen...-trials_en.pdf

  5. #5
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    Just a question on this, Do the MHRA still refer to the Annex 11 guideline for CSV even after Brexit or does the MHRA have speciifc guidance on what deliverables must be produced in CSV ?

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