Why this blog?
I have become involved as a commenter in several blogs about clinical research, CDISC standards, e-Health, electronic health records, so that I think it is now start to start my own one.
What I will do in this blog is give my thoughts about the CDISC standards, my involvement in their development, my involvement in different IHE-profiles for integration of electronic health records (and eHealth in general) and clinical research, and from time to time some technical tips, especially for working with ODM, define.xml, and SDTM and SEND standards.
I am now involved in the development and implementation of CDISC standards for 10 years, and I can say that I can (almost) claim to be a "CDISC guru". I think I am one of the very few independent consultants that have so many years of experience with the set of CDISC standards.
But I do not want to keep all this knowledge for myself. I want to share it with others. That's one reason for starting this blog. Another is that it is sometimes a good thing to publicly comment on what is currently happening with standards in healthcare, especially in the area of electronic health records and CDISC.
Where can we do better? What is holding is up? Why do acceptance and implementation take so long? What is the status of these standards at the FDA?
These are all topics I have a meaning about, and which I will try to post here.
I apologize in advance if people feel bad or even insulted by my comments. I have seen that people that have been involved in the development of a specific standard feel insulted when I criticize a standard. They shouldn't.
Standards development work is human work, and often compromises must be made in order to get them accepted by all stakeholders. Even when I say something negative about a standard, or give suggestions for improvements, this does not mean that I criticize the people that developed the standard. At the contrary, I have a huge amount of respect for these people.
So let us start now. I hope you will like this blog and send many comments.
Jozef Aerts, XML4Pharma