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Correction to a case...does it go as a follow up?

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  • Anon
    18/04/2016 10:30
    Hi, I have a scenario where serious reportable cases had findings during the retrospective QA reviews. The findings from QA have been considered as follow up information and the cases submitted with a new date. Is this acceptable as per GVP Mod 6? Can someone help me interpret the below mentioned from GVP Mod 6. In situations where the case is modified without impacting on its medical evaluation, while no new follow-up is received (e.g., for correcting a mistake or typographical error), the date of receipt of the most recent information reported in the data element ‘Date of receipt of the most recent information for this report’ (ICH-E2B(R2) A.1.7 ) should not be changed. This data element should however be updated in any other situations, to the date when new follow-up information is received (independently whether it is significant or not) or to the date when changes are made which impact on the interpretation of the case.
  • GPvP Committee
    13/07/2016 17:51
    It depends on what the actual findings from QA were and whether they impacted the interpretation of the case. If the case was modified following QA review without impacting on its medical evaluation (for example there was a correction to a spelling), and no information identified during QA review that was missing in the submitted case then the ‘date of receipt’ should not change. If however the QA review identified information that either altered the evaluation or identified information that was missing in the submitted case, this would be considered as ‘new’ information and the ‘date of receipt’ should be updated.
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