EXECUTIVE SUMMARY & OPERATIONAL TAKEAWAYSARZON DOSSIER
- CDISC SDTM (Study Data Tabulation Model) standardizes human clinical trial data for clear regulatory review.
- ADaM (Analysis Data Model) datasets are derived directly from SDTM to support statistical modeling and hypothesis testing.
- FDA electronic submission (eSUB) guidelines require valid define.xml metadata files accompanying all SDTM/ADaM submissions.
- CDISC data specialists earn premium compensation across global pharmaceutical sponsors and contract research organizations.
1. The CDISC Data Ecosystem
The Clinical Data Interchange Standards Consortium (CDISC) establishes global vendor-neutral data standards. Standardized data models allow regulatory reviewers at the US FDA and Japan PMDA to run automated data validation scripts across thousands of clinical trial submissions.
2. From CDASH Collection to SDTM Tabulation
The progression of clinical trial data:
- **CDASH**: Collects data at trial sites via eCRFs with standard field names and formats.
- **SDTM**: Organizes collected data into domain tables (DM, AE, CM, EX, LB, VS).
3. ADaM Architecture & ADSL/ADAE Specifications
ADaM datasets are designed explicitly for biostatistical analysis:
- **ADSL**: Subject-Level Analysis Dataset containing baseline characteristics and treatment arm allocations.
- **BCC (Basic Data Structure)**: Used for time-series lab and vital sign analysis.
4. Define.xml & Regulatory Validation
Every submission must include a `define.xml` file serving as the data dictionary, specifying domain structures, codelists, and derivation algorithms.
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