Dianthus Medical Blog Archive

CDISC protocol representation model

Those of you who follow such things carefully will know that CDISC have recently released a draft of their new protocol representation model (PRM). The current model is only a draft version, and CDISC are keen to receive comments on the model from as wide a variety of potential users as possible. If you feel you have something to contribute, have a look at the model and let CDISC know what you think.

I seem to have been "volunteered" to  co-ordinate an official response on behalf of EMWA, something about which I actually feel quite enthusiastic. I'll be collating comments from a team of EMWA members who between them know pretty much everything there is to know about writing protocols, and feeding it back through the CDISC channels. In the meantime, I was privileged to join in one of the CDISC PRM team's regular teleconferences yesterday, and pass on some preliminary feedback as a result of discussions we had at last week's EMWA conference.

In short, I'm very impressed with the model. It seems very flexible in the way it can model a huge variety of different study designs, although doubtless in this first draft there'll be one or two things that aren't perfect. Hopefully we'll spot them during this review process. Our main criticism at this stage, however, was that the document didn't explain things as well as it should if it's aimed at an audience of medical writers, who by and large are not familiar with things like the unified modelling language on which the model is based.

Nonetheless, I really think the PRM is a hugely exciting development in clinical research. It has the potential to revolutionise not only the way we write protocols, but also the way that protocols can feed into other parts of the clinical research process with much more automation (think reduced costs and reduced potential for cock-ups) than we currently use, such as designing CRFs, setting up clinical databases, and writing reports.

Watch this space.

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