Good Clinical Practice Guide
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Thread: Data Archival Requirements

  1. #1
    Forum Member
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    Dec 2014
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    Question Data Archival Requirements

    Where could we find some guidelines/guidance documents on the subject of data archival requirements?

    As the Sponsor, we have received notification from the Medical Imaging Service Provider that they have completed the final data transfer for our study. The Medical Imaging Service Provider has contacted us (Sponsor) regarding our needs for data archival. The Medical Imaging Service Provider can either archive the study images, data and materials, or they can send it all to us (Sponsor) for archiving. Is this data considered "source documents" and as the Sponsor can we accept it?

  2. #2
    Forum Member
    Join Date
    Nov 2011
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    A good source of information and some guidance documents can be found at the Scientific Archivists Group web site www.sag.org

    Was the “Medical Imaging Service Provider” contracted to scan all the trial documentation following completion and not actually involved in the conduct of the trial?

    If the images are of trial documents presumably the original documents/data/information are with the people who generated that data (e.g. the investigator).. If the documents/data/images include such things as; the Investigator site files; and/or any patient records or information that could identify they, then the sponsor should not receive these records. It is difficult to be any more specific without more information.
    There is also information on clinical archiving at www.therqa.com.

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