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.
Very interesting ... I would love one of your team to contact me about writing a case study for our new journal (due out September). Perhaps you could get in touch with me.
AJ de Montjoie
CDISC Director Media and Communications
Thanks for the post which may be the only one on PRM.
I share your feeling about the lack of implementation guidance. I think the word "implement" is a bit vague here. I am not sure what it means exactly. PRM is supposed to help protocol writers first. How would a protocol author implement it? Should all components of a protocol be stored in a standard compliant document (e.g. an XML file with certain schema) and the actual protocol be generated from it?
Hong, it seems that at the moment the implementation is up to individual companies and software developers to sort out. It seems pretty clear to me that you'll need some kind of software.
We're working on how to do this at Dianthus at the moment, and I'll blog again when we've got something workable.
The PRG Group welcomes your comments and participation. As the PRG lead, I am very interested in receiving your feedback, particularly as we are in the midst of development of the PRM Implementation Guide. It is important to note that one need not implement software, specifically, in order to obtain benefits from the model. In in simplest form, the model provides a list of recommended attributes to be included in your study design, and most notably the protocol document.
Hi David
Thanks for the comments, let's stay in touch. I was on Lisa's mailing list for the PRM at one stage, although haven't had any emails for a while. Don't know whether there haven't been any or whether I've dropped off the list, but would love to stay in contact about this.
Adam