Process for remote source data verification

Covid-19 queries

Home Forums QUALITY ASSURANCE (QA) Covid-19 queries Process for remote source data verification

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    I was wondering what processes other CTU’s are following for conducting remote monitoring (or in particular remote source data verification)?

    For example;

    If pseudoanonymised source data are being provided for source data verification, how is it being received and stored? And how long retained for? (ie. Secure electronic transfer, restricted folders etc)

    How is remote source data verification being evidenced for audit trail and inspection purposes? How it is being stored and retained? (ie. Worksheets/checklists completed electronically and saved to secure folder)

    I would appreciate any advice.

    Thanks in advance


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