The CDISC Interchange

It’s that time of year again and our team are heading to the CDISC Interchange in Amsterdam to present and exhibit. Did you know that we have now been involved with CDISC in one form or another for over 10 years? In that time, we have been members of the E3C (European CDISC Coordinating Committee), have become CDISC recognised trainers for SDTM and ADaM and we support companies implementing CDISC standards and with submission to regulatory agencies. In addition, we now have our A3 Suite that is revolutionising the way our industry works with standards and you can find out about that at the Interchange and or on our website.

Where to find us this week

Please go and meet our team at Stand 11 (right next to the buffet!). You can chat to Kirsten Langendorf, Dorte Straarup, Johannes Ulander, and Adam de Neergaard. They can talk you through our services and demonstrate the benefits of using the A3 Suite.

As well as leading the SDTM Training, Johannes Ulander is presenting in Session 4, Track A Submissions on Wednesday 8th May. 

Understanding the Technical Conformance Guide

The importance of the technical conformance guides are increasing and they are getting more detailed for each new release. It all began with the CDER Common Data Standards Issues Document released May 2011 which was created because CDER, who has accepted SDTM datasets since 2004, had observed significant variability in submissions containing standardized electronic clinical data.

This document mainly contained high level advice such as planning for SDTM prior to study conduct to avoid a legacy migration process as it will make it more complicated to adhere to the SDTM Implementation Guide, as well as a very detailed request for adding EPOCH, ELEMENT and ETCD to all subject level observations. The last request was updated in the next version of the document 6 months later with a disclaimer that this is not a requirement as it is associated with implementation challenges for sponsors (and ELEMENT and ETCD were removed.)

Now we all know this document by its new name, the Technical Conformance Guide, and it exists at FDA as well as at PMDA. With each new release more detail is added and the latest FDA Technical Conformance Guide even adds terminology to use and new domains that do not yet exist; essentially making them standards on their own.

This presentation will present an analysis of some of the more detailed suggestions in FDA Technical Conformance Guides and their implementation challenges covering:

  • Introducing new terminology
  • Logically skipped items in the QS domain
  • Requiring the DV domain
  • Adding Treatment Emergent supplemental qualifier to AE
  • Managing multiple enrolments in DM

Kirsten Langendorf will also be presenting in Session 4, Track C End to End on Wednesday 8th May.

Towards a Biomedical Concept Library: Creating and Sharing Biomedical Concepts

There has been much talk over the last few years about end-to-end (E2E), beginning-to-end (B2E) and ways in which we, as an industry, can achieve these aims. One solution is the use of Biomedical Concepts across the life-cycle to build operational artefacts based upon a set of common definitions. To achieve the desired outcome, we need the actual BCs covering the desired content, for both the safety domains and therapeutic areas.

This presentation will report on work focused on investigating whether it is possible to create BCs from existing content like define.xml. We will demonstrate how a semi-automated process using tooling can create BCs. The presentation will show how those that are familiar with CDISC standards can use the process to create new BCs.

This presentation will detail:

  • The approach taken
  • The process used in creating a BC
  • The tooling used and the sources of information required including define.xml files
  • The technology employed within the tooling.
  • The use of templates to ensure consistency of the content created
  • The resulting outputs
  • How this work has been extended to the CDISC TAUGs, i.e. how defining BCs can improve the definitions of TAUGs and make them more useful to the community.
  • The current state of the work
  • How the results can be used even by those not using BCs but will find the more complete definitions useful
  • How the results can and will be shared with the community

The presentation will conclude with the status of the work, next steps and potential impact.

We will be posting the slides after the event but please get in touch if you want CDISC implementation support or you would like to see a demo of the A3 Suite.