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CDISC SDTM Workshops

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Showing 13–24 of 50 categories
SDTM Define-XML Documentation
Practical training on creating and maintaining Define.xml documentation for SDTM datasets and regulatory submissions.
3+WORKSHOPS
PROGRAMMES
Define-XML Schema Validation and Compliance Auditing Variable Metadata Mapping and Computational Algorithm Documentation Define-XML Generation from SAS and R Environments +2 more programmes
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CDISC ADaM and SDTM Integration
Advanced program covering the relationship between SDTM and ADaM datasets for analysis-ready data creation.
3+WORKSHOPS
PROGRAMMES
SDTM to ADaM Dataset Mapping Architecture Implementing ADaM Derivations from SDTM Source Data CDISC Controlled Terminology Integration and Validation +2 more programmes
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SDTM FDA Submission Requirements
Compliance training focused on meeting FDA and regulatory agency SDTM requirements for clinical trial submissions.
3+WORKSHOPS
PROGRAMMES
SDTM Domain Mapping for FDA Regulatory Submissions SDTM Validation Rules and Submission Readiness Handling Complex SDTM Scenarios in Clinical Trials +2 more programmes
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SDTM Database Design and Architecture
Technical training on designing database structures to support SDTM data collection and standardization.
3+WORKSHOPS
PROGRAMMES
SDTM Domain Mapping and Variable Architecture Design Implementing SDTM Relationships and Referential Integrity SDTM Qualifier and Supplemental Qualifier Architecture +2 more programmes
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SDTM Electronic Data Capture Integration
Hands-on workshop connecting EDC systems to SDTM standards for seamless clinical data capture and mapping.
3+WORKSHOPS
PROGRAMMES
EDC to SDTM Domain Mapping Strategies SDTM Validation Rules in Electronic Data Capture Build SDTM Define.xml from EDC Metadata +2 more programmes
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SDTM Metadata Management Systems
Training on implementing metadata repositories and management systems for SDTM data governance.
3+WORKSHOPS
PROGRAMMES
SDTM Domain Mapping and Variable Standardization Define-XML Generation and Metadata Documentation SDTM Validation Rules and Quality Assurance +2 more programmes
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SDTM Data Traceability and Audit Trails
Specialized program on maintaining data lineage, audit trails, and traceability throughout the SDTM standardization process.
3+WORKSHOPS
PROGRAMMES
Implementing SDTM Audit Trail Metadata Structures Source Data Mapping and SDTM Traceability Documentation SDTM Data Provenance Validation Using Define-XML +2 more programmes
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SDTM Mapping Rules and SOPs
Practical training on developing standard operating procedures and mapping rules for consistent SDTM implementation.
3+WORKSHOPS
PROGRAMMES
SDTM Domain-Specific Mapping Implementation Workshop CDISC SDTM Qualifier and Variable Relationship Mapping SDTM Controlled Terminology Application and Validation Rules +2 more programmes
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SDTM Sponsor and CRO Collaboration
Program designed for teams managing SDTM handoffs and collaboration between sponsors and contract research organizations.
3+WORKSHOPS
PROGRAMMES
SDTM Domain Mapping Strategy for Sponsor CRO Alignment Define.xml Governance and Cross-Functional Collaboration Protocols SDTM Submission Package Validation for Multi-party Environments +2 more programmes
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SDTM Excel to SDTM Conversion
Practical workshop on converting legacy Excel data and non-standard formats to compliant SDTM datasets.
3+WORKSHOPS
PROGRAMMES
Automated SDTM Domain Mapping from Excel Excel to SDTM Variable Standardization Workflow SDTM Qualifier and Relationship Management in Excel +2 more programmes
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SDTM Software Tools and Platforms
Hands-on training on industry-standard SDTM software tools, platforms, and technical applications for data standardization.
3+WORKSHOPS
PROGRAMMES
SDTM Domain Mapping Using SAS Programming Pinnacle 21 Community Validator Implementation Guide Define.xml Generation for SDTM Datasets +2 more programmes
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SDTM Nomenclature and Abbreviations
Training on proper usage of SDTM nomenclature, standardized abbreviations, and naming conventions.
3+WORKSHOPS
PROGRAMMES
Domain-Specific Variable Naming in SDTM SDTM Abbreviation Standards and Implementation Qualifier and Role Nomenclature Mastery +2 more programmes
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