We talk about CDISC standards repeatedly in our blog, because we know the importance of CDISC in clinical trials. Formedix was one of the first ever CDISC members back in 2001, and we’ve been very actively involved with CDISC ever since. We helped to develop many key features in CDISC ODM and Define models, and continue to be gold members of CDISC.
A quick recap: Who are CDISC and what do they do?
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Basically, these standards make clinical data easier to understand and interpret.
“We develop and advance data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a powerful framework for generating clinical research data that is as accessible as it is illuminating” (CDISC, 2021).
If you’re looking to find out a bit more info about CDISC and its standards, you can read our blog posts, An overview of CDISC standards, A guide to CDISC standards used in the clinical research process & Using SDTM, ADaM, and SEND for regulatory submissions. Or you can download our helpful free guide: "CDISC standards required for regulatory submission"
Why CDISC standards should never be ignored in any clinical trial
1. The use of CDISC standards allows externals to understand clinical trial data FAST
Using CDISC standards in a study ensures that any external individual who is not involved in a clinical trial, such as a regulator or another research group, quickly understands all information contained in the clinical trial. They don’t have to ‘decode’ results first, as the information is standardized and recorded using a specific set of abbreviations, codes, etc.
2. Increase the amount of useful clinical data
If multiple studies use the same data standards, they can be compared with each other, possibly analysing data in different ways. Research groups within an organization that use CDISC standards can easily extract data from existing datasets, and reuse it for further research. This increases the amount of useful clinical data that can be derived from a single study.
3. Enhance the interoperability of clinical research systems
Clinical trials are complex and involve the use of various software systems for different phases of the trial. CDISC standards ensure that data is standardized, and this helps when it comes to integration with multiple systems.
4. CDISC standards are a requirement for regulatory submission in a growing number of countries
The use of CDISC data standards in clinical trials is a requirement for submissions to the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). They are also the preferred standards for electronic data submission to the Chinese National Medical Products Administration (NMPA). Find out more about global regulatory requirements.
As clinical trials become more global, the use of CDISC standards will continue to increase and it is expected that more regulatory agencies will make these compulsory.
How Formedix can help you implement CDISC standards in your clinical studies
As seen throughout this blog post, CDISC standards should never be ignored, as they provide many benefits for organizations, regulators and the whole clinical trials industry. And their positive impact is becoming clear to regulatory bodies across the globe.
As we mentioned earlier, we have been members of CDISC since its inception, and our clinical metadata repository and study automation platform ryze is built on CDISC-compliance. By choosing to work with us, you will automatically comply with CDISC. Plus, we have a team of experts that can provide various types of CDISC training to help get you up to speed. Contact us today to find out more about what we can offer!