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Detailed demographic information

Detailed demographic information I was interested in collecting more demographic information for the subject than what is available on the subject form. Is the only way to do this using a CRF for demographics?
Also, will this cause any issues for 21 CFR part 11 compliance?
Thanks,
-Jerry

Comments

  • Detailed demographic information I was interested in collecting more demographic information for the subject than what is available on the subject form. Is the only way to do this using a CRF for demographics?
    Also, will this cause any issues for 21 CFR part 11 compliance?
    Thanks,
    -Jerry
  • Hi Jerry,

    You would in fact have to create a separate CRF to capture the detailed demographic information you are looking for. There are no standard places in OpenClinica to collect names, race and ethnicity etc.

    Thanks,
    Paul
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    Paul J. Galvin
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    Akaza Research
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    Sent: Thursday, February 25, 2010 12:33 PM
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    Subject: [Developers] Detailed demographic information

    I was interested in collecting more demographic information for the subject than what is available on the subject form. Is the only way to do this using a CRF for demographics?
    Also, will this cause any issues for 21 CFR part 11 compliance?
    Thanks,
    -Jerry
This discussion has been closed.