IMPLEMENTING CDISC USING SAS PDF

Once again, it was my pleasure to collaborate with Chris Holland, and I am glad that we had a chance to update the book with current software and standards. That leaves me thinking about where we are right now in terms of clinical trials standards and compliance, and I am a bit concerned. Oh, how they have grown. If you take the current basic ADaM documentation, which includes the model, implementation guide, time to event, OCCDS and examples document you are looking at reading pages. Those 1, pages of clinical data standards continues to grow, and so does their interpretation. This lack of rigidity leads to multiple interpretations of the standards across implementations in the industry.

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Once again, it was my pleasure to collaborate with Chris Holland, and I am glad that we had a chance to update the book with current software and standards. That leaves me thinking about where we are right now in terms of clinical trials standards and compliance, and I am a bit concerned. Oh, how they have grown.

If you take the current basic ADaM documentation, which includes the model, implementation guide, time to event, OCCDS and examples document you are looking at reading pages.

Those 1, pages of clinical data standards continues to grow, and so does their interpretation. This lack of rigidity leads to multiple interpretations of the standards across implementations in the industry. The FDA has a technical conformance guide that adds additional requirements to the CDISC standard requirements, and now they have a new technical rejection criteria document as well. Add it all up and you have a lot more to understand beyond the1, pages of base standards. As the standards teams continue to evolve the CDISC standards, and as we get evolving interpretations and additional requirements layered over the base standards, things are getting a tad complex.

At times, it has me wondering if this increasing standards complexity is the way to go. We need an easy button for clinical data submissions.

Have we created one yet?

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