Comprehensive Guide for Clinical Trial Data, Genomic Research, and Real-World Evidence
The WIA Medical Research Data Standard (WIA-MED-029) provides a comprehensive framework for clinical trial data management, research data sharing, IRB protocols, informed consent management, biobank data, genomic research data, real-world evidence (RWE), and publication data management. This standard fully supports CDISC (Clinical Data Interchange Standards Consortium) standards and follows FAIR (Findable, Accessible, Interoperable, Reusable) data principles.
Supporting SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), CDASH (Clinical Data Acquisition Standards Harmonization), ODM (Operational Data Model) and other standards, it ensures data quality, integrity, and traceability throughout the clinical trial process. It also covers genomic data standardization, biobank integration, and real-world data (RWD) utilization.
Full implementation of CDISC standards including SDTM, ADaM, CDASH, and ODM for regulatory compliance.
Integrated platform for secure research data sharing, multi-site collaboration, and meta-analysis.
Institutional Review Board protocol submission, approval, amendment management, and ethics compliance.
Electronic informed consent (eConsent), multilingual support, version control, and audit trails.
Standardized formats for NGS data, gene expression, variant analysis, and privacy protection.
Biospecimen storage, tracking, quality control, and researcher access management integration.