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Thread: Patient medical notes and source data

  1. #1
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    Jan 2012
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    Patient medical notes and source data

    I wondered if anyone could clarify the requirement for retention of patient medical notes if they hold source data for a study. When it is said that these must be held for at least 5 years after discontinuation of the
    Study or for the maximum period allowed by the institution does this mean after this time they could in theory be destroyed ( subject to meeting nhs code for record retention) or does it mean they can they be
    stored in a different media .
    If the former is true then am I correct in assuming the retention period for the Tmf and study records differs from the requirement for subject medical record?
    Thanks for any clarification you can give .

  2. #2
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    If the study is likely to be submitted as part of a product licence application (MAA) or amendment then source data which the application is based upon, should be retained for at least 15 years [or ICH E6 criteria] (2001/83/EC as amended).
    EU Guidance Volume 10 Chapter 5 is very useful about this. Also the EMA GCP Inspectors website Q & As. Also the EMA GCP Inspectors reflection paper on electronic source which contained guidance on paper source as well. Here the inspectors propose the ALCOACCEA quality standard for source. So source documents should be available when needed for monitoring, auditing and inspection. Hence the choice of how to archive is a business decision, but the material must be readily available, complete (inc meta data); accurate; legible (in a human readable form); attributable; contemporaneous; enduring (not likely to fade or decay in the retention period); consistent ; and readily available.
    The MHRA GCP Guide does give information about safeguards regarding destruction of TMFs and also transfer to microfiche.

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