Dianthus Medical Blog Archive

CDISC protocol representation model released

Regular readers of this blog may remember that I was quite excited when the draft of the CDISC protocol representation model (PRM) was released last year. I am delighted to be able to tell you that the final version of the model was released last month. Again, I am quite excited.

It is pleasing to see that many changes were made to the draft model in response to the comments that I and some other EMWA members made on it. Most of my comments related to the opaque nature of the model, and although it's still quite hard to get to grips with the model, the explanations of how it works seem considerably clearer in the final version than they were in the draft.

But it is still a very complicated model. We have it printed out on 18 sheets of paper and stuck to the wall of the office so that we can get a good look at it. And very pretty it looks too.

At the moment, CDISC have given no guidance on how the PRM should be implemented. We are very keen to start using it at Dianthus, so we will have to figure out the implementation ourselves, which we have already started working on. I just hope that the lack of implementation guide doesn't mean that our implementation will end up being incompatible with other companies' implementations of it, but no doubt any problems in that area can be ironed out at a later date.

CDISC are currently working on extending the operational data model to include trial design data. No doubt that will also be an interesting development when it is released, hopefully some time later this year.

In the meantime, we plan to start using the CDISC PRM when we write our protocols within the next few months. This should make the whole process of writing protocols considerably more efficient (ie quicker, cheaper, and with less risk of errors or inconsistencies), as well as leading to downstream efficiencies such as allowing automatic generation of case report forms.

We'd love to know what you think of how the CDISC PRM has the potential to improve clinical research. If you have any thoughts, please leave a comment below or contact us.

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