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Thread: Inspection Dossier and Computer Systems

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  1. #1
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    Inspection Dossier and Computer Systems

    Hi,

    As part of my company's inspection preparations we have been updating our MHRA GCP inspection dossier and have come across differences of opinion with reference to completion of section 1, item 3 - Computer Systems. The differences stem from the company being mostly virtual with several vendors providing services which has led to differing theories as to what needs to be included in this section. These range from just the systems the company directly manages to every single system involved in our studies including those that were implemented and are managed by external parties (e.g. EDC).

    Does anyone have experience/an opinion on this?

    Many thanks.

  2. #2
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    Would be really useful if the GP Inspectors were to answer this!

    I would think that it is best if you ask yourself "why do the inspectors want this information?" It is probably so that they can prepare for their inspection in which case they need to know everything as they are bound to come across all the systems whilst inspecting. It would be good to tell the inspectors that there are some systems which are not operated from the sponsor office that they will be inspecting, so that they can prepare. Remember that the inspectors may inspect the CROs you are using either as part of this inspection or as another CRO inspection.
    As the sponsor (Virtual or not) will have oversight of the entire development programme of clinical trials, they will be familiar with all the computer systems being used even if they do not operate them themselves. There may be some systems (such as Serious Breaches; deviation escalation; USMs; SUSARs; etc that the Sponsor will have ands on but others which they only have general oversight of. You could ask your lead inspector what they want. I suspect they may want a list of all systems and perhaps a listing of the subgroup of those which the sponsor operates or receives frequent updates from. The MHRA GCP Guide (2012) has got stuff on Sponsor oversight.

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