CDISC stands for the Clinical Data Interchange Standards Consortium. It is a global not-for-profit organization that develops data standards for the pharmaceutical industry. Study Data Tabulation Model (SDTM) defines a standard structure for human clinic
The landscape of clinical trial data standards being quite complex, it appears critical, using the lessons learnt from ourpast experience at implementing Clinical Data Interchange Standards Consortium (CDISC) Study Data TabulationModel (SDTM), to thoroughly assess what is needed and why this is ...
What is an insider threat? An insider threat is a cyber risk originating from within an organization. These threats can involve actions such as an employee inadvertently clicking on a malicious link (e.g., a phishing email) or an employee with malicious intent conducting data exfiltration for ...
Looking ahead, integrating laboratory manual standards with broader industry initiatives, such as CDISC’s SDTM model, can ensure continuity from protocol design to data analysis. This alignment would enable full traceability of data and processes, accelerate evidence generation by removing barriers to co...
The CDISC Study Data Tabulation Model (SDTM) [1] defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the FDA. These data tabulations,delineated in the CDISC SDTM and augmented by the clarity ...
Define-XML 2.0.0 is a major revision of the Define-XML standard for transmission of SDTM,SEND and ADaM metadata. Version 1.0.0 was released for implementation in February 2005 [2]. Define-XML hasbeen a useful mechanism and critical component for providing Case Report Tabulation Data Definition...
CDISC is also actively collaborating with other partners on the development of Therapeutic Area Data Standards. We have to notice that not only for SDTM, but also for other CDISC models, the release of new standards has been accelerated. The Technical Plan Project Schedule provides a detailed ...