CDISC SDTM, ADaM, TLF/TLGs
CDISC (Clinical Data Interchange Standards Consortium) is an open, nonprofit organization whose goal is to “develop global standards for packaging, reporting clinical research data and also to support electronic acquisition, exchange, submission and archiving of clinical trials data to improve medical research, product development and related areas of healthcare”. The main aim is to develop platform-independent standards to improve data quality and accelerates the process.
Duration:
Course Content:
- SDTM Metadata
- Table of Contents Metadata
- Variable-Level Metadata
- Value-Level Metadata
- Computational Method Metadata
Define File Header Metadata
Define File Creation SAS Program
- Implementing CDISC SDTM with SAS
- SDTM codelist creation
- Creating SDTM Domains
- ADaM Metadata