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OpenClinica Data Extract in ICH E2b R2 Format...

Hello All,

Is there anyway we can extract the Data from OpenClinica to E2b Format which is widely used for SAE Reporting

Comments

  • kristiakkristiak Posts: 1,336 ✭✭✭
    As long as you include all the elements required by the ICH-e2b-r2 format in your database design, yes you can.
  • kapeekapee Posts: 3
    via Email
    Can you share some Information on how this can be done

    Regards,
    Kapil
  • kristiakkristiak Posts: 1,336 ✭✭✭
    First you have to create CRF's containing all the needed data and then create a report of the desired format. This would have to adopted to the country where you want to submit the data. EMA and F&DA have electronic submissions, I do not know where you want to send the SAE info.

    Beast wishes
    Krister
  • kapeekapee Posts: 3
    Hi Kristiak,

    I don't wish to send the information directly to EMA or FDA but just get the data in the E2b XML format either R2 or R3 format only. Do you know how to do that?

    Regards,
    K
  • kristiakkristiak Posts: 1,336 ✭✭✭
    We don't handle the SAE's that way so we have never done it, but if the e-CRF is properly designed I see no problems getting the data out in a suitable XML format.

    Best wishes

    Krister
This discussion has been closed.