CDISC Standards for Clinical Data
BIOL-40317
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.
Course Information
Course sessions
Section ID:
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This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
Policies:
- No refunds after: 1/13/2025
Schedule:
Instructor:
Sunil Gupta, M.S.
Principal SAS CDISC Consultant, Gupta Programming
Sunil Gupta, MS, is an international speaker, best-selling author of five SAS books, and a global SAS Developer and CDISC SME and corporate trainer. Sunil is an advocate of CDISC automation and standardization with over twenty-five years of experience in the pharmaceutical industry. Most recently, Sunil is teaching Practical R for SAS Programmers, a CDISC online class at the University of California at San Diego, and classes on Data Science using SAS at UCLA and UCSD Extension. In 2019, Sunil published his fifth book, Clinical Data Quality Checks for CDISC Compliance Using SAS and in 2011, Sunil launched his unique SAS mentoring blog, SASSavvy.com, for smarter SAS searches and R-Guru.com for R Programming. Sunil has MS in Bioengineering from Clemson University and a BS in Applied Mathematics from the College of Charleston.
