The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Avoiding Lost-in-Translation with Submission Terminology

February 24, 2021

In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM. However, the CDISC-CT is not the only submission terminology you need to be familiar with when building SDTM datasets to be submitted to the FDA (and similarly to the PMDA). As per the FDA Data Standards Catalog, when submitting datasets to the agency, you need to follow not only the CDISC standards (SDTM, ADAM, define-xml and CDISC-CT) but also a number of other submission terminologies. For example, this is the case of MedDRA when your SDTM package contains Adverse Events data, or WHO Drug Dictionary for Medications, but there are also a number of other submission terminologies you need to apply, particularly in the TS – Trial Summary Dataset.

A number of presentations and papers have been published discussing TS domain[1] and clarify requirements that are not always fully clear in the SDTM IG or in the agencies Technical Conformance Guide.

In this blog, I focus on TS and discuss some specific parameters that you need to submit in TS using various “external” dictionaries, and help you understand how to find the correct term (and code).

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The Missing Link: Risking your Traceability (and “Credibility”) when your ADaM package is not traceable back to SDTM

October 28, 2020

About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO deliverables, mainly for SDTM and ADaM packages. At first, I was involved in the review cycle of SDTM, and began by reviewing some initial mapping specifications including a draft SDTM Annotated CRF. The CRO in charge was quite experienced and there was nothing major to spot in all the different versions I had to review.

Surprisingly, it was not the case some months later, when I had to provide the same review support for the Biostatistics deliverables, specific to the ADaM package. The ADaM datasets overall were well designed, and there were no major open non-conformance issues. However, it was clear from the very beginning that there was something missing - a missing link between SDTM and ADaM.

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Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi - Part 2

April 27, 2020

In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC converted our physical event into a virtual one and was held on April 1-2, 2020. I provided a summary of the updates received from the three main health authorities - the US FDA, the Japanese PMDA and the European EMA.

This post offers an overview of the other sessions I attended at the 2020 Virtual CDISC EU Interchange. The agenda was well planned and organized. The distinguished speakers were extremely prepared and answered numerous questions after their presentations. Continue reading for further highlights from the event.

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Highlights from the 2020 Virtual CDISC EU Interchange by Angelo Tinazzi

April 24, 2020

In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C) together with CDISC decided to cancel our physical event in Berlin, planned for April 1-2, 2020. It was a tough decision, but unavoidable and necessary.

We did not let this dampen our spirits and immediately came up with an alternative plan – go virtual with the event! In only two weeks the team managed to pull together a revised program and the registrations were opened on the CDISC website. The scale of the event went from being Europe-only to Global, and around 300 people attended it worldwide. In the end, the event was a hit. Everything worked out very well, with no major technical disruptions and the speakers respecting the allocated time slots.

In this two-part blog post, I share a summary of the sessions I was able to attend, while simultaneously ensuring business continuity for my regular projects.

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