CDISC Standards for Clinical Data

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that develops and supports data standards to improve medical research and ensure research data is easily interpreted and understood by regulators. The CDSIC established standards support the acquisition, exchange, submission and archive of clinical research data.

In this course, students will learn the skills and tools necessary to apply the CDISC standards when processing clinical data used for FDA submissions. Specifically, this course will focus mapping raw datasets to CDISC’s Study Data Tabulation Models (SDTM) and Analysis Dataset Models (ADaM).

Topics include:

• CDISC terminology and standards
• ISO 8601 dates and durations and creating DM and ADSL demog datasets
• Processing AE, SUPPAE and ADAE adverse datasets
• Converting LB and ADLB Lab datasets
• Understanding QS, RELREC, EX and TE/TA/TV datasets
• Validation of SDTMs and ADaMs
• ODM-XML files structure and content
• Creating and QCing DEFINE.XML
• Understanding oncology domains

Practical experience:

• Create DM/SUPPDM and ADSL datasets
• Create AE and ADAE datasets
• Create LB dataset

Software: Students must download and install SAS OnDemand for Academics: Enterprise Guide. There is no additional cost for this product. Registration and download information will be provided by the instructor on the start date.

Course typically offered: Online in Winter and Summer

Prerequisites: Prior knowledge of clinical trials and familiarity with SAS programming (such as SAS Programming I) suggested.

More Information: For more information about this course, please contact appliedscience@ucsd.edu.

Course Number: BIOL-40317
Credit: 3.00 unit(s)
Related Certificate Programs: Biostatistics