The Version Management Wave. No, not a new dance, though it does conjure up thoughts of dad dancing. I refer to something I have been talking to a quite a few people about over the last year. I refer to an impending flood of changes in standards and the impact that these changes will have on organisations that are trying, and in some cases struggling, to get the best out of standards.
There are a number of drivers. This is not an exhaustive list, just enough to illustrate the issue:
- From CDISC we have SDTM and the various Implementation Guides; issue 3.1.2 and 3.1.3 out already with 3.1.4 coming shortly and 3.1.5 being talked about. Release 3.1.3 did not bring massive change but the same cannot be said about Issue 3.1.4.
- CDISC are also issuing new Terminology quarterly.
- The Therapeutic Area development from FDA and CDISC contributes to the above, new domains and terminology.
- FDA and PDUFA V. We now see the slow movement towards mandatory electronic submission, have a look here.
All of this will force organisations to consider the important version management issues and there will be an awful lot of it. When do I use X? When should I move from version X to version Y? What is the impact of version X on the organisation? Version control will become an issue and a very important one. The problem will grow.
Why? Just a few examples:
- One I saw recently was in the new Asthma TA out for review. This is not a TA our organisation is interested in but tucked inside are Pulmonary Function Tests. PFT do interest us but not all the tests we use are covered within the proposed standard, some are but not all. We have more complete terminology for the tests we do use (including the new suggested CDISC ones) so when the final standard does emerge, we will have to work out what changes and what remains sponsor-defined. This ignores commenting on the standard and the additional workload that brings.
- The quarterly release of terminology and the time taken to assess what has changed, does that change impact our CRFs, domain specifications etc. And then when should we implement those changes?
- Study builds and recording what was used to build a given study. As we build or change a study new definitions are created and we see an increase in the number of definitions we are managing.
The new releases of standards and associated terminology will have a significant impact on organisations in terms of the resources needed to manage standards and to govern those standards. There will be a prolonged period of change and a feeling that the ground is forever moving below the people whose job is essentially to bring stability.
This post has barely scratched the surface of what will become a major issue for organisations. But we have a little time to prepare, so I thought it was worth pointing out something that I have been trying to assess and deal with over the last year or so. Interesting times and challenges are ahead of us all.