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Thread: Scanned Source Documents

  1. #1
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    Scanned Source Documents

    My organisation is progressing with the development of a new electronic patient record and intends to be "paper light" in the next year or so.
    I am interested in hearing of anyone's experience of using scanned documents as source documents and what issues/hurdles that you may have
    encountered and how these were resolved. Thank you.

  2. #2
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    Scanned is good enough for me and if an entire NHS Trust is using scanned documents it would be absurd to refuse to accept them. As long as patient identifiers are clear so you know what you are looking at, I doubt anyone would object to this. More than 10 years ago I was monitoring sites in Germany using electronic patient records and always used the scanned documents on the system as source. It would have been completely impractical to do anything else.

    I think the key here is that the data is highly unlikely to have been manipulated during scanning. The worst that might happen is that a scanned document ends up in the wrong patients file. I think that is complete different to accepting an excel spreadsheet of data as source when in fact it has been entered onto the spreadsheet from an original paper source.

    Hope that is helpful,

    CTU

  3. #3
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    MHRA has commented on this before. The BARQA website has a list of Q & As by the MHRA.
    MHRA GCP Consultative Committee, 20-May-05
    Q Electronic storage of Trial Master Files - would the MHRA still require that paper copies be held in addition to the electronic records?
    A: If the original is generated on paper (e.g. requires a ‘wet’ signature), then paper originals are expected to be kept. However, the organisation may choose to perform a risk assessment for destruction of originals, whilst maintaining scanned electronic versions. It is advised to wait for the outcome of the Trial Master File guidance from the Commission.
    Later note:- The “Recommendation on the content of the trial master file and archiving (July 2006)” has been published as part of Eudralex Volume 10. This provides guidance on storage media to be used.

    MHRA GCP Consultative Committee Meeting 11 Sep 2009
    Q; Investigators are asking if, at the close of the study, they can scan their entire Site Mater File (containing the ICH GCP essential documents), electronically store this information on their server, and then destroy the originals. Are there any problems with this approach? Also sometimes sponsors are sending investigators information which is only in electronic format (such as Investigators brochures, process manuals, CD-ROMs of eCRF data, etc) how should this be stored?

    A; The EU Directives state that essential trial documents must be retained for defined periods. There is no mention of circumstances where they can be destroyed before the defined periods have elapsed.

    It is possible to transfer authenticated copies to other media, but it is the responsibility of the sponsor and chief investigator to ensure that the TMF (site and sponsor) is a complete and accurate collection of all essential trials. It would be their responsibility to demonstrate that this was so where they have allowed essential documents to be transferred to other media.

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