Westat’s experience with implementing the Clinical Data Interchange Standards Consortium (CDISC) standards began over 10 years ago. We have the expertise to transform your data into a submission-ready format.
What is CDISC, and when is it required?
Westat has experience implementing the CDISC standards required for data management, programming, documentation, and eCTD data submission, on both current and legacy clinical trials.
CDISC stands for Clinical Data Interchange Standards Consortium, a not-for-profit global organization that has developed and published data standards for the pharmaceutical industry for over 20 years. According to the CDISC.org website, CDISC standards are recognized and required by regulatory agencies (US FDA and Japan PMDA) around the world. Their goals are increased quality and greater efficiency, leading to scientific breakthroughs that will have an invaluable impact on clinical research and global health.
We take your data from the collection point to the final submission, while efficiently and expertly adhering to the CDISC standards!
The key components of a CDISC data submission package are:
- CDASH – compliant data collection forms and database
- SDTM – compliant data sets, that represent the data as it was collected
- ADaM – compliant data sets, which contain analysis data
- Controlled Terminology, which consists of standardized code lists applied throughout the CDISC data package
- Supporting Documentation, which includes reviewer’s guides, annotated data collection forms, and a complex metadata file called Define.xml
Westat has the tools and experience to apply each of these components to your project and improve yourchances for a successful submission.
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