CDISC Implementation
CDISC foundational standards include CDASH for data acquisition, SDTM for tabulation, ADaM for analysis, and SEND for nonclinical data. These models define datasets, variables, and controlled terminology to ensure consistency across studies. SDTM domains group data by topic, using two-character codes and required variables like identifiers and timing.
Implementation Steps
Begin with staff training on CDISC principles and project specifications. Develop CDASH-compliant case report forms (CRFs) and databases early, then map raw data to SDTM domains using transformation specifications. Validate datasets with Pinnacle 21 checks during collection, create analysis datasets, and prepare submission components like define.xml.
Submission Package
Include SDTM/ADaM datasets, annotated CRFs, study reviewer’s guide, and TS domain for eCTD validation. Use tools like transformation models for non-standard data and metadata guidelines for compliance. Benefits encompass faster reviews, reduced costs by 60%, and improved global data quality.