Posted on 12/6/2018 6:55 AM
Doreen van Huyssteen, Manager, Data Management, MMS
For this edition of Expert Insights, we talk with Doreen van Huyssteen, Manager of Data Management at MMS – based in Bloemfontein, South Africa.
What is the difference between CDISC and CDASH, and why should these standards be followed?
The Clinical Data Interchange Standards Consortium (CDISC) is an organization that develops and supports global data standards to improve the quality and interoperability of medical research. The Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) are divisions of CDISC. CDASH standards focus on data collection, such as what is needed to complete on an electronic case report form (eCRF). Meanwhile, SDTM focuses on data reporting, including what needs to come out of the database and in to the tables and listings. SDTM is required by the U.S. Food & Drug Administration (FDA), but CDASH is not. When data is collected using CDASH, it becomes much easier downstream to convert data into SDTM formatting, as required for regulatory submissions.
What are the overall benefits of standardization in data management?
When data is standardized the development time of a database is greatly reduced, as standard eCRFs and edit checks can be reused. Additionally, the efforts of the allocated resources to build the database are reduced, and data collection is streamlined to a point where clinical programming teams can use standard macros. When using CDISC standards, as mentioned previously, all data management efforts can be mapped directly to SDTM. This simplifies downstream clinical programming efforts, making the whole process simpler. I always keep in mind how good data management best practices affect all of the other parts of the submission process.
In regards to the implementation of data management standards at MMS, what have you done?
At MMS, we have created a group of standard specification documents that outline the domains that are a requirement in almost all studies. For instance, this may relate to adverse events or medical history. Taking this a step further, these standard documents have been built into industry-leading electronic data capture (EDC) systems, including Oracle InForm, Medrio, and IBM Clinical Development. These serve as a library for future studies, allowing for new studies to have a solid starting point. As a company, we have been a member of CDISC for more than 10 years now and are continually in proactive conversations about standards and the future of data management.
Speaking of the future – do you expect any future changes to standards in data management in the pharmaceutical industry? If so, when?
Changes to standards in the world of data management are an ongoing process. Each time a new version of CDASH and SDTM is released, it is a top priority to learn and implement any changes. Because of that, anyone that works in this industry must operate on an evolving set of standards and updates. At this point, the next review cycle of the CDISC standards are not certain, but we expect more in 2019. When thinking about the future, I like to reflect on the past a bit. The changes that the pharmaceutical industry has seen in the past five to 10 years is nothing short of remarkable, and I am sure the next five to ten will bring even more improvements to make our data stronger and our patients healthier.
To ask Doreen a data management question, email email@example.com