Good Clinical Practice Guide
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Thread: Certified Copies

  1. #1
    Forum Member
    Join Date
    Mar 2018

    Question Certified Copies


    Nowadays, we have techniques and oversight techniques to ensure that anything printed on paper is a certified copy of the original. However, how do we apply this when copies come from outside clinical trial sites? For example, a patient has an SAE and is admitted to a hospital that isn't the clinical trial site - the documents sent over from the admitting hospital are copies but not labelled as being certified, the originals (perhaps EMR) can never be compared with and a QC check of the copying process can't take place.

    Is there a minimum standard that needs to be met in these circumstances?

    Any advise would be greatly appreicated!


  2. #2
    Dear Billiejo, shouldn't we start with the question, whether the copies mentioned in your example need to be certified at all? The original documents still stay at the admitting hospital, you are not intending to replace any original by copies, the investigators receives a kind of "report" form the admitting hospital (a kind of dear doctor letter, discharge letter perhaps with attachments) - this is becoming part of the source at the investigational site. I personally would not expect a certification. But I am very interested in hearing others' feedback.
    Kind regards,

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