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Comparing blood results data against reference ranges in a multicentre trial

Ideally I would like to have a CRF of reference ranges for each Site, then use Rules to check against that Site-specific range.
We have thought of having quite long-winded Rules ...if site is A values should be less than X, if Site is B then value should be less than Y, .....
Site -specific CRFs, hiding all except the relevant when a new subject is created; then relatively simple Rules/validation for each CRF

Is there any neater solution? Thanks


  • RCHENURCHENU Posts: 207
    I think it will be very hard to maintain using OC and OC rules as normal ranges are different by labs but could also be stratified by age, gender... Multiple units could also be available for one parameter, and effective date can also change during the study because of a new reagent....
    I will strongly advise to do your checks outside of OC if you want to keep it "simple" (which is never the case with normal ranges anyway !)

  • mtaylormtaylor Posts: 5
    Thank you for the advice....at least this confirms that we have not been missing out on an OpenClinica feature!
  • RCHENURCHENU Posts: 207
    Maybe you can also get some ideas from here:
  • bfarrowbfarrow Posts: 30 admin
    Hi Romain and Marian,

    I emailed Marian separately, but wanted to put the gist of my response here in case anyone else is looking to solve the same problem.

    Building edit checks into CRFs is even easier with OC4 than it is with OC3.x, so it's certainly feasible to create as many site-specific forms as you need, each reflecting that site's ranges. Then, with auto-query, any out-of-range value will (if not modified before the form is closed) automatically generate a query, visible to you and the site.

    Bryan Farrow
    eClinical Catalyst at OpenClinica
    (It's my job to tell the eClinical world what we've done and what we're doing, and to learn what else is needed in that world to get better data faster.)
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