How to design response labels for different response types

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  • mcoynemcoyne Posts: 20
    Dr. Aerts,
    -- If you have a chance to use Openclinica, please post your opinions on the
    forum.
    -- There is no argument about values that standards bring.
    -- There seems to have a difference in opinions with regards to the
    following two approaches:
    a. CDISC from the ground up: GUI implements CDISC to exporting data
    in CDISC
    b. Excel to allow for gathering data from researchers --> export data
    in CDISC. My guess is that with this approach validate of data will be
    different than if a software starts with CDISC from the ground up. (Note
    that this is a lot of risk for a software company -- the software company
    invests completely on CDISC).
    I don't' believe OC facilitates importing data in CDISC format, at
    this moment.
    -- With regards to Validation -- I think there is something here that I
    don't fully understand. I do know that OC does validate its excel sheet.
    But with regards to the issue that you were mentioned about 2 different
    users of CRF (the author researcher who created the CRF, and another
    researcher who use the same crf), I have not envisioned it would be a
    problem with OC.
    Scenario 1: both researchers using ONE central database -- OC will check all
    its Excel (for general syntax as I mentioned in couple e-mail before); when
    OC loads the excel, it definitely check the central db. There are many
    sub-cases that ran through my head, but I don't see a problem yet.
    Scenario 2: both researchers use separate databases. They both can change
    the CRF to fit with THEIR needs. Upload and use both CRFs (might or might
    not be same any more) in their own databases. A problem will arise when
    both decides to upload their data (and crf) into same db. (I believe this
    is my original counter-argument with Michael Sweeney with regards to 'there
    is no system wide' response label, values, types). At the same time, I
    don't see how a software that adopted CDISC from the ground up, would escape
    this problem without a proper design. (this is a classic problem of
    distributed environment; it is orthogonal to whether one accepts standards
    or not.)
    As always, it is my humble opinions and always want to learn more from
    experts.
    My C.

    -----Original Message-----
    From: dr. Jozef Aerts [mailto:[email protected]]
    Sent: Saturday, December 02, 2006 3:29 PM
    To: [email protected]; 'Sidhu, Bobby [CORP]'
    Cc: [email protected]
    Subject: Re: [Users] How to design response labels for different response
    types
    Thanks,
    It's getting to become an interesting discussion indeed !
    I am located in Europe, that's probably why you haven't seen me at
    conferences in the US yet. I try to catch 1-2 conferences in the US each
    year, but that is not always possible. Most of my customers are EDC vendors
    (both in the US and Europe) that need help with CDISC implementation.
    One of my recent customers specializes on rescue studies, and without CDISC
    standards this would be very difficult or nearly impossible.
    I think OpenClinica is a great development, is the first open source
    clinical system after Phosco that may become successful (others failed).
    I agree that if researchers feel more comfortable with Excel for CRFs, than
    they can use it,but the problem of portability between EDC system remains.
    OpenClinica does already have export in CDISC format which I think is very
    (but also the easiest to implement), but there is still a way to go (Lab
    data for example, what format does OC use for that ?)
    I think researchers indeed shouldn't have themselves ask what kind of widget
    should be used (i.e. the visual stuff) but that is also not what I meant. A
    study design tool (at least if based on CDISC standards), only requires that
    the user defines the question, the datatype (integer, float, date ...),
    whether there is a list of possible answers (codelist) and whether an answer
    to the question is mandatory or not. The EDC system should then
    automatically create the eCRFs and the visual layout (look-and-feel) based
    on some predefined rules. So this should not have to cost a single dollar
    and the researcher can concentrate on the science.
    I do not know what Excel costs in the US nowadays, but it is not for free,
    so also there there is a cost, although it may be hidden. For an open source
    system I was a bit surprised that it encourages to use Excel, and not for
    example OpenOffice, which is open source and freely available.
    And I do agree, some study design tools are overpriced !
    About the validation, this might be less an issue when the designer of the
    CRF is at the same time the user of the EDC system. But what in the case the
    designer of the CRF is at another location, has another function, and thus
    never sees the CRFs after they have been ported to the EDC system. What
    guarantee is there that the CRF is the same in the EDC system than in the
    worksheet ? I know that study design tools need to be validated, and the
    forms that come out of it, so I presume that also the Excel systems need to
    be validated. I know from practice however that usually this isn't done, as
    it is difficult to do...
    I think also the FDA issue is important. Sponsors need to submit the study
    data AND metadata to the FDA. The FDA is encouraging sponsors to do this in
    CDISC format. They are more and more also asking for the annotated eCRFs
    (i.e. unfilled, but annotated with submission - SDTM - information, i.e.
    which clinical domain and which submission SDTM variable), and the ideal
    format for this is CDISC ODM. I do not mean a visual representation of the
    eCRF, but the questions, codelists used, data types, application logic
    etc.., also the science and logic behind the CRF.
    To finalize, it is not an utopia that an EDC system is being set up fully
    automatically from a study desing in CDISC ODM format. I know of at least 5
    EDC systems that have this feature. The study design is either made using a
    study design tool or an XML editor (which can be cheaper than Excel). The
    whole DB and EDC system is then set up in usually less than a minute. It
    might be less an issue in academic research, but doing so, the cost of EDC
    design is decreased enormously (sponsors sometimes pay pretty large amounts
    of money for that).
    I downloaded OC a few weeks ago, but haven't found the time yet to start
    working with it. I hope to have so during the next week. I will also try to
    set up CRFs using the worksheet mechanism (although I will try to use
    OpenOffice). So I can see how that works. I am especially interested how
    question dependency logic (e.g. automatically skip the question about
    pregnancy when the investigator enters that the subject is male) and range
    checks can be and are implemented.
    I am very positive about OC so far, but I find their statement "OpenClinica
    uses an extensive data model based on the CDISC standard for clinical
    research" pretty exagerated. But maybe I should first have a look at the
    source code to find out what the data model exactly is.
    Have a very nice weekend,
    Jozef Aerts
    XML4Pharma
    P.S. Just a remark about the naming "OC". In large pharma and at CROs, it is
    used for "Oracle Clinical" so indeed confusing isn't it ?
    ===========================================================================
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