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 Historyhttp://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!