2025 CDISC Europe Interchange
On 14 and 15 May 2025, the CDISC Europe Interchange will take place in Geneva. We are proud to announce that we have submitted three abstracts. The committee is currently reviewing the submissions.
Best Practices for Efficient
CDISC-Compliant PK NCA
by Mitchikou Tseng
The application of CDISC standards in Pharmacokinetic (PK) Non-Compartmental Analysis (NCA) is essential to ensure standardization and better reproducibility of the datasets reporting PK concentrations and parameters. This presentation will outline best practices for executing CDISC-compliant PK NCA analysis, offering a clear understanding of how to optimize PK analysis workflows.
A key focus of this presentation is to provide insights on planning a robust programming framework to facilitate seamless analysis reruns, particularly between interim and final analyses, while adeptly handling both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies. Strategic tips on the derivation of PK-related parameters and supporting variables within the workflow hierarchy will also be tackled along with the intricacies of programming SDTM RELREC (Related Records), with a special focus on scenarios involving manually derived PK parameters. Furthermore, it will also be explored whether the use of the ADaM Non-Compartmental Analysis (ADNCA) dataset can serve as a replacement for the traditional Pharmacokinetics Analysis (ADPC) dataset.
By adopting these best practices, both experienced PK analysts and those new to CDISC standards in PK analysis will be able to streamline their PK NCA workflows systematically and effectively.
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CDISC Compliant ISS
Submission: A Use Case
by Lieke Gijsbers
The integrated summary of safety (ISS) is a critical component of
a submission to the FDA regulatory authority. For the ISS, data from different studies are pooled and harmonised to conduct
the integrated analyses. Different strategies can be used to create the integrated datasets.
The ISS may be accompanied by integrated SDTM/ADaM Define‑XML and integrated Reviewer's Guides (icSDRG and iADRG) to provide additional context and information about the integrated SDTM and ADaM datasets.
Based on a use case, we’ll explain in this presentation the approach we took to create CDISC compliant integrated datasets. Furthermore,
we’ll share our experiences regarding the creation of an SDTM and ADaM Define-XML for integrated datasets as well as the icSDRG and the iADRG.
Bridging the standards: standardized mapping and lineage
by Jules van der Zalm and Berber Snoeijer (ClinLine)
Our industry has been mapping data from one standard to another for decades. This includes mapping of clinical trial data from collection to submission standards as well as mapping other study data like real-world data utilized for regulatory purposes. While standards such as CDISC and OMOP exist for the data itself, there is no industry standard for documenting the mapping process and metadata. Consequently, there are many different ways of documenting, noting and storing the mapping details. In most cases this information is not computer-readable and the actual mapping is a non-standardized, case by case task, translating the mapping specification into computer programs.
This presentation shows how we store the mapping information to ensure data lineage and FAIRness, and to improve the efficiency in the mapping process. We will illustrate this by examples of mapping real-world data with an open source tool we are developing to show the mapping lineage over multiple transformation steps.