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do you cdisc?

Hi all,
I took the survey Rob sent around recently, and I began to wonder: how much (if at all) does CDISC matter to OpenClinica users & developers?
Having CDISC integrated into the design of OpenClinica is one of it's selling points, and it is a pretty sensible set of standards, but I wonder if researchers which aren't planning to ever need to submit data to a regulatory agency (in particular the FDA) are bothering with implementing it?
I haven't had the pleasure of preparing a portfolio for drug regulatory submission, but I gather that the main requirement at the moment is that the submission is organised according to (e)CTD, which seems to deal mainly with the submission file structure and content for each section.
I've scratched around on the FDA, EMEA and TGA (Australia) websites and only the FDA seems to go further than eCTD by recommending specific methods for tabulation, which requires CDISC.
As an interesting aside I found a guidance document [1] by the FDA which suggests that the reality of the CDISC standards is (or was, in 2011-12) not particularly standardised anyway.
[1] http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM254113.pdf
Best regards,
Lindsay

Comments

  • lindsay.stevenslindsay.stevens Posts: 404 ✭✭✭
    Hi all,
    I took the survey Rob sent around recently, and I began to wonder: how much (if at all) does CDISC matter to OpenClinica users & developers?
    Having CDISC integrated into the design of OpenClinica is one of it's selling points, and it is a pretty sensible set of standards, but I wonder if researchers which aren't planning to ever need to submit data to a regulatory agency (in particular the FDA) are bothering with implementing it?
    I haven't had the pleasure of preparing a portfolio for drug regulatory submission, but I gather that the main requirement at the moment is that the submission is organised according to (e)CTD, which seems to deal mainly with the submission file structure and content for each section.
    I've scratched around on the FDA, EMEA and TGA (Australia) websites and only the FDA seems to go further than eCTD by recommending specific methods for tabulation, which requires CDISC.
    As an interesting aside I found a guidance document [1] by the FDA which suggests that the reality of the CDISC standards is (or was, in 2011-12) not particularly standardised anyway.
    [1] http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM254113.pdf
    Best regards,
    Lindsay
  • Re: [Users] do you cdisc? This email adress is not valid anymore. Your mail has been automatically forwarded to [email protected] and will be treated rapidly.
    If you still want to reach me please send your email to [email protected]
    Thanks,
    Julien
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