CDISC Rules 2

In my last posting, I discussed potentially using ARDEN as a syntax for expanding CDISC ODM with rules.

After a couple of months of on and off investigation, I have decided that ARDEN is dead as an option. Actually, ARDEN is largely dead as a potential syntax in general.

The value of a rules syntax lies primarily in the potential ability to put context around data once it reaches a repository or data warehouse.

In theory, the transfer of rules would be of value in transferring a study definition between systems. However, I cannot think of a really valuable situation where this might happen. If data is captured into an IVR System and then transferred across to EDC – does it really matter if they both have access to the rules? Instead, the rules could be applied by one of the systems.

That last point takes me to the other reason why rules are less critical. If the last decade was about standards development this new decade must be about standards application – and, in particular the real time exchange of data between systems. The need to validate data in System A first, before transferring it to System B is only really necessary if System A cannot check directly with System B. With the increasingly prevalent Web Services combined with standards – it will be possible to carry out these checks online.

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