Good Clinical Practice Guide
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Thread: Validation of Clinical Trial Sample Assays

  1. #1
    Forum Member
    Join Date
    Nov 2016

    Validation of Clinical Trial Sample Assays

    I have a question on validation of sample analysis for clinical trials. Is a publication on validation of assay sufficient to document validation techniques or a separate document has to be produced for validation techniques?

  2. #2
    Forum Member
    Join Date
    Apr 2017
    Hi, this may be too late a reply for you but...
    A publication is not likely to be sufficient to document validation activities (and certainly not a publication that you did not author).
    For a validation I would expect to see a plan (signed off and QA authorized) before the work has started and then a report. All the source data for the validation activities should be available for data audit and, again, the report should be signed off and QA authorized. These are not steps that could easily be transparent in a publication.

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