Good Clinical Practice Guide
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Thread: Using REDCap?

  1. #1

    Using REDCap?

    Hello

    We are hoping to implement REDCap within our unit and wondering if anyone else is using this data capture tool and, if so, what data validation procedures you have in place?

  2. #2
    Forum Member
    Join Date
    Nov 2011
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    The producers of REDCap state that it "is not 21 CFR Part 11 compliant". Although this is not a problem in the EU, it is a word of warning. The "REDCap Technical Overview" supplied by the producers on their website, also does not mention any computer system validation or status. It would be prudent to ensure that your system was "Fit for purpose" and hence you would have to conduct a proportionate validation of your system as it is when it is working. There are various courses on CSV. However I am not allowed to be helpful and mention these, but I am sure that a well known search engine (mentioning no names) would list a lot of these. Also professional not-for-profit associations (mentioning no names) might be useful to you as well. It would be good to hear from others who have installed this system.

  3. #3
    Here is a wiki page for REDCap.

  4. #4
    Forum Member
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    Validating REDCap appears to be a DIY job. What is unclear is how this would be possible without access to a functional specification such that you could write and execute an OQ. I'm assuming when you download you'd get sight of the IQ (?) but has anyone unearthed (paid for?) an OQ? Without this you'd be left trying to use validation of individual studies as the basis for overall system validation. Not ideal, and I wouldn't be comfortable facing an inspector on this basis.

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