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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 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).
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a pleasant “promenade”.
The CDISC Library forms the foundation of an ongoing transformation in the way we will access and make use of the CDISC standards to facilitate the long awaited and desired, end-to-end data process implementation (see also the CDISC 360 project).
With the availability of the CIDSC Library, vendors can now develop software which you can use to instantly access standards i.e., Standards Controlled Terminology or data standards (for example SDTM). Standards are now available in machine readable and non-proprietary format.
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog saw a lot of activity as we tried to keep our readers abreast with the latest updates on the COVID-19 clinical trials, and covered other trending and important topics such as, the growing adoption of Synthetic Control Arms, master protocols, Head to Head Comparisons and Bayesian methods. We also collaborated with several experts from both within and outside the company to conduct several series of webinars and provided summaries through our blogs.
Continue reading to learn about the top 10 Cytel blogs that resonated most with our community in 2020.
“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to put on top (the After) when your regulatory group has finally submitted the eCTD to the FDA . A good start is to have early discussions with the agency by regularly meeting them and sharing the status of your clinical data standards. While, the cherry on the top is the continuous support you need to guarantee to your submission project to promptly react when the reviewers come back with questions and additional requests during the review process.
CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was only in the last decade that it became “The Standard”, particularly when Health Authorities (HA), such as the US FDA and Japanese PMDA, made it a requirement for data submissions to support most of the regulatory requests for market approval. Additionally, most of the Pharma companies made the CDISC standards a part of their operational data model and consequently, the number of studies using the CDISC standards increased across phases of development.
The benefit of receiving data in standard formats was soon recognized by HA reviewers as they now require lesser time to understand the structure of the data they receive. Integration of data provided by different sponsors, for example on the same indication, for better understanding of safety signals, has become possible with data submitted in standard CDISC format.
However, the HAs such as the US FDA, soon realized that this was not enough, for two main reasons:
- sponsors sometimes make bad or different interpretations of the standard
- lack of standards or use cases in specific disease areas or indication
From the time the COVID-19 outbreak was declared a pandemic, the number of studies conducted around the world to either diagnose, prevent or treat the virus literally exploded (1570 as on today, according to the Cytel Global Coronavirus COVID-19 Clinical Trial Tracker1).
Moreover, the pandemic impacted the regular schedule of ongoing clinical trials. Health authorities such as the FDA, promptly provided recommendations in the form of questions and answers on how to handle “disruptions” due to the pandemic2. These disruptions include a range of challenges including skipped assessments or study withdrawal.
“CDISC launched a task force in an effort to support CDISC members and the research community as they work tirelessly to discover critical breakthroughs to treat COVID-19 …. The task force was launched with the goal of developing Interim User Guide and Related material” said David Bobbitt, CDISC CEO, in an interview with Outsourcing-Pharma.com3. On April 21, 2020, the task force released two guidances. In this blog, I provide you with a quick summary of what these guidances address.
The two guidances are:
- Guidance for Ongoing Studies Disrupted by COVID-19
- CDISC Interim User Guide for COVID-19
Continue reading to learn more.
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.
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.
With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers for following and appreciating the Cytel blog. This year, we collaborated with several experts from both within and outside the company to bring to you a range of interesting topics including real-world evidence, AI, challenges in rare diseases, patient-reported outcomes, data management, and our popular series “The Good Data Submission Doctor” and “Career Perspectives”. In this blog, we share with you the top 5 Cytel blogs that resonated most with our community in 2019.
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