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Editable closed case

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  • Anon
    27/07/2018 10:27
    Not a PV expert. Can a closed case in a safety database be editable (fields including date of receipt etc).
  • Shaun Hastings
    23/08/2018 10:52
    I am no PV expert, but I have seen there has been no reply to this post yet, so I wanted to share my opinion. Your question is quite brief, but in my opinion, it is important to focus on what the data in the safety database is used for and if a case if closed and fields updated retrospectively (e.g. receipt date) what impact does this have on the data integrity and the processes that follow (e.g. reporting to CA). Systems are usually designed to allow mistakes to be corrected and tracked via an audit trail or a Data Clarification Form to preserve the integrity of the data. There should also be processes in place within the organisation to manage these types of mistakes and a process for closing and re-opening a case. Typically if a case is closed all fields should be frozen (much like the clinical database) and no longer editable to the end user and only un-frozen or re-opened by completing a request form etc. For me, it's not a clear yes or no answer, as it depends on risk and the impact changes to closed cases can have on the integrity (and further processing) of your data.
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