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Thread: Medical Images Requirements

  1. #1
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    Medical Images 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? Where could I find some guidelines/guidance documents on the subject?

  2. #2
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    Quote Originally Posted by tymbusku View Post
    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? Where could I find some guidelines/guidance documents on the subject?
    Medical Images are source data you can keep a certfied copies in your eTMF for archival, however Sponsor should not have exclusive source data control therefore the investigators should file the original in the patient medical files.
    The guidance is the ICH-E6 you can find some additionnal in the concept paper on electronic souce data.

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