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CRF design question - how to best align with CDASH

Hi all,

Currently I’m designing a CRF that collects medical history for a prostate cancer study. I want to align as much as possible with the CDISC standards and therefore want to use CDASH terms for the item_name in the OpenClinica CRF.

If I understand CDASH correctly than for each medical history event or condition I should collect the following information:
MHTERM: containing the medical history event or condition
MHOCCUR: indicating if it happened for a particular subject
MHSTDAT: start date of the event or condition
MHENDAT: end date of the event or condition

See CDASH V1.0 section 5.13 Medical History
http://www.cdisc.org/standards/cdash/downloads/CDASH_STD-1_0_2008-10-01.pdf

Since I already know what conditions I want to collect information on (e.g. did the patient have a prostatetectomy, does the patient smoke, did the patient receive hormone therapy, etc) I created a separate Group per condition. In each group the MHTERM is a single select field with only one option, which is the condition I’m interested in, this is also the default so that the user entering the data will not have to change this field. The MHOCCUR is a radio box with yes, no, unknown.

So in my “Items” tab I have multiple ITEM_NAMEs with the same name: MHTERM, MHOCCUR, MHSTDAT, MHENDAT, each occurring in a different Group. Unfortunately this is not allowed, as according to the instructions the ITEM_NAME should be unique in the CRF.

Does anyone have experience/suggestions on how I can best create my Medical History CRF for OpenClinica that is aligned with the CDASH standard?

Btw according to the CDISC ODM standard the ItemOID (which OpenClinica generates based on the ITEM_NAME) should be unique in an ItemGroup, but does not have to be unique in a form. So there is a slight difference here between CDISC and OpenClinica.

Thanks in advance for any help!

Regards,
Frank

Comments

  • Hi all,

    I sent below message to the users list but didn’t receive any response. Is there someone on the developers list that could help me understand how to best use CDASH terminology in OpenClinica CRFs? See below message for the details.

    Thanks!

    Regards,
    Frank
  • JozefJozef Posts: 71
    The CDASH set of forms (and specification) is currently only available as a PDF document.
    The CDISC ODM&CDASH teams are currently working on an ODM representation which we hope to publish within the next 1-2 months.

    Unfortunately, OpenClinica cannot import Form definitions in ODM format yet (as far as I know, it is however planned for the future).

    It would of course be great if a group of OpenClinica users could do the same thing as the ODM&CDASH team did, but for the OC Excel format, and share the results with the OC community.
    Another solution would be to wait for the ODM representations, and generate a little piece of generic software that transforms CRF definitions in ODM into CRF definitions in OC-Excel. The latter can then be styled (radiobuttons vs. dropdownlists e.g.) by individual users.

    For your specific question, there seems to be a small difference between how OC uses items (questions) and how the ODM does.
    In CDISC ODM, each item (ItemDef) is reusable, and can be added once to each subform (ItemGroup). So one can have 5 groups on a form each of them having the same questions. This seems not to be possible in OC (P.S. I didn't check).
    What you could do is to copy the questions, i.e. use MHTERM_SMOKE, MHTERM_HORMONE_TERAPY, etc..
    so that you have a unique instance within each group.

    Best regards,

    Jozef Aerts
    XML4Pharma
    CDISC ODM Team member and lead developer
This discussion has been closed.