Module 12 2019

CDISC : The Clinical Data Interchange Standards Consortium • CDISC develops global standards and innovations to streamline medical research and ensure a link with healthcare • CDISC Standard: SDTM (Study Data Tabulation Model) ➢ Defines a standard structure for human clinical trial and non-clinical study data tabulations

http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/de fault.htm

The Organisation for Professionals in Regulatory Affairs