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CDISC Interchange Meeting 2011 Notes and Highlights

Belgium beer, waffles, chocolate and CDISC are absolutely some of my favorite things experienced at the CDISC Interchange meeting last week. Below are some of my notes, thoughts and observations from the meeting. I wanted to get this out while the information is still hot. If you want any more details on any particular CDISC topic, please leave me a comment and I will do my best to provide them.

CDISC SDTM Submission Content

  • The FDA reviewers are medical doctors and not necessarily experts in data review or software applications such as SAS.
  • There is a difference in the reviewers’ preferences when looking at clinical data, so make sure you find out what your reviewer prefers. Some reviewers look at CDISC SDTM data, some only look at CDISC AdAM data, etc.
  • The supplemental SDTM domains don’t get as much attention as the main SDTM domains.
  • The Pre-NDA or End of Phase II meeting is where the FDA reviewers like to discuss the CDISC standards that will be used in the submission. These discussions can include where to put certain types of data (supplemental datasets vs. custom datasets vs. findings datasets). Statisticians and lead programmers should attend this meeting and bring questions or an overview of preliminary plans.
  • SDTM content should be validated and there are many tools to do so.
  • The following information can be found on the FDA website:

Discussions around CDISC EHR Integration

  • Countrywide EHR development in Holland was halted recently due to concerns with privacy.
  • European countries are moving much faster to EHR.
  • The EHR4CR (Electronic Health Records for Clinical Research) project aims to design and demonstrate a scalable and cost-effective approach to interoperability between Electronic Health Record systems (EHRs) and clinical research through multiple but unified initiatives across different therapeutic areas.
  • According to a study referenced by Pierre-Yves Lastic, 13.4% of EHR data collected is used in clinical research. With the number being this small, in my opinion, the prospect of electronically transferring this data is not as exciting as it once was.

What other CDISC Interchange topics are of interest to you? Let me know what you would like to learn more about in the comments section below. To see tweets from CDISC events, please follow eclinical_jen on twitter.

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