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CDISC Compliance & Regulatory Submission Mastery

$199.00
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A tailored course, built for your situation

CDISC Compliance & Regulatory Submission Mastery

Master China’s clinical data submission standards and accelerate regulatory approval

$199 one-time
24-hour access provisioning 30-day money-back guarantee Hand-built implementation playbook
12 modules. 12 chapters per module. 144 chapters total.
12 modules, each with 12 chapters (144 chapters total), text-based, plus downloadable templates and a hand-built implementation playbook delivered alongside course access.
Your team is drowning in rework because NMPA submissions don’t align with CDISC standards , delays are mounting, and audits are exposing gaps in metadata consistency and traceability.

The situation this course is for

As CDISC China’s chair and a recognized instructor, you're positioned at the intersection of global standards and local regulatory enforcement. Recent updates show China tightening clinical data requirements, demanding SDTM and ADaM compliance with stricter metadata validation. Yet, many teams still submit with inconsistent naming, missing domains, or failed conformance checks , leading to rejection, resubmission, and lost time. The gap isn’t knowledge; it’s implementation at scale with audit-ready precision.

Who this is for

Regulatory leads and data science consultants guiding pharma and biotech through CDISC-compliant submissions in China

Who this is not for

Entry-level data managers without submission authority or teams not yet using CDISC standards

What you walk away with

  • Eliminate rework by aligning submissions with NMPA and FDA CDISC expectations
  • Implement metadata-driven automation to reduce validation errors by 70%
  • Build audit-ready SDTM and ADaM datasets with full traceability
  • Reduce submission cycle time by standardizing programming workflows
  • Lead cross-functional teams through compliant, repeatable submission processes

The 12 modules (with all 144 chapters)

Module 1. China’s Regulatory Landscape for Clinical Data
Understand the evolving NMPA requirements for electronic submissions and how they intersect with CDISC standards. Explore recent policy shifts, inspection trends, and the implications for data structure, metadata, and validation. Learn how to classify studies based on submission risk and regulatory scrutiny level.
12 chapters in this module
  1. NMPA vs FDA submission scope
  2. Recent regulatory changes in China
  3. Classifying submission risk levels
  4. CDISC adoption timeline in China
  5. Inspection triggers and red flags
  6. Data privacy and residency rules
  7. Submission formats accepted
  8. Common rejection reasons
  9. Regulatory communication protocols
  10. Preparing for pre-submission meetings
  11. Building a regulatory watch function
  12. Mapping internal workflows to NMPA
Module 2. CDISC Standards: SDTM Fundamentals
Master the core structure of SDTM datasets, domains, and variables. Learn how to apply the CDISC metadata model correctly, ensure proper naming conventions, and avoid common implementation errors. Includes real-world examples from oncology and cardiovascular trials.
12 chapters in this module
  1. SDTM model overview
  2. General Observation Classes
  3. Domain naming rules
  4. Variable naming conventions
  5. Role definitions and usage
  6. Timing variables explained
  7. Origin and method metadata
  8. Comment handling
  9. Dataset metadata structure
  10. Controlled terminology use
  11. Define.xml essentials
  12. Validation checklist
Module 3. ADaM for Analysis-Ready Datasets
Build ADaM datasets that support regulatory analysis and transparency. Learn how to derive analysis variables, maintain traceability to SDTM, and structure metadata for auditability. Focus on AEs, efficacy, and safety endpoints.
12 chapters in this module
  1. ADaM principles and goals
  2. Dataset naming conventions
  3. Analysis variable derivation
  4. Traceability to SDTM
  5. AE analysis datasets
  6. Efficacy endpoint structure
  7. Safety dataset design
  8. Parameter coding standards
  9. Analysis flags and filters
  10. Metadata for analysis
  11. ADaM validation rules
  12. Define.xml for ADaM
Module 4. Metadata-Driven Automation
Implement metadata-driven programming to reduce manual errors and speed up dataset creation. Learn how to use metadata templates, automation scripts, and validation checks to ensure consistency across studies and teams.
12 chapters in this module
  1. Metadata as single source
  2. Automation framework design
  3. Template-based programming
  4. Script validation protocols
  5. Error handling in automation
  6. Version control for metadata
  7. Cross-study consistency
  8. Integration with CDISC
  9. Testing automated outputs
  10. Team adoption strategies
  11. Audit trail requirements
  12. Scaling automation
Module 5. Define.xml and Submission Packages
Build complete, compliant submission packages with properly structured define.xml files. Learn how to document metadata, structure datasets, and validate submission readiness before delivery.
12 chapters in this module
  1. Define.xml structure
  2. Documenting metadata
  3. Dataset references
  4. Variable properties
  5. Controlled terminology refs
  6. Data structure diagrams
  7. Validation using Pinnacle
  8. Common define errors
  9. Submission package layout
  10. File naming standards
  11. Checklist for final review
  12. Versioning and updates
Module 6. Validation and Conformance Checking
Ensure datasets pass regulatory validation using automated and manual checks. Learn how to use open-source tools, internal validation scripts, and CDISC conformance rules to catch issues early.
12 chapters in this module
  1. Validation principles
  2. Using Pinnacle25
  3. Custom validation scripts
  4. Conformance rules
  5. Error classification
  6. Log interpretation
  7. Common failure patterns
  8. Fixing validation errors
  9. Internal audit process
  10. Peer review workflow
  11. Validation documentation
  12. Submission readiness sign-off
Module 7. Traceability Across SDTM and ADaM
Establish full traceability from raw data to analysis datasets. Learn how to document derivation paths, map variables, and ensure audit readiness through clear, consistent documentation.
12 chapters in this module
  1. Traceability principles
  2. Variable mapping methods
  3. Derivation paths
  4. Programming specs
  5. Analysis data flow
  6. ADaM to SDTM links
  7. SDTM to raw data
  8. Traceability matrices
  9. Audit inspection prep
  10. Documentation standards
  11. Version control
  12. Team review process
Module 8. CDISC Implementation in China
Navigate local challenges in CDISC adoption, including language barriers, legacy systems, and regulatory interpretation differences. Learn best practices for training, governance, and cross-border collaboration.
12 chapters in this module
  1. Local adoption challenges
  2. Language and translation
  3. Legacy system integration
  4. Regulatory interpretation
  5. Training non-native speakers
  6. Cross-border teams
  7. Vendor management
  8. Internal governance
  9. Change management
  10. Documentation in Chinese
  11. Audit expectations
  12. Scaling across regions
Module 9. Preparing for Regulatory Inspections
Get audit-ready with documentation, training, and mock inspections. Learn how to anticipate inspector questions, organize submission materials, and respond to findings.
12 chapters in this module
  1. Inspection preparation
  2. Document organization
  3. Mock inspection process
  4. Common inspector questions
  5. Response protocols
  6. Team training
  7. Audit trail review
  8. Gap assessment
  9. Corrective action plans
  10. Post-inspection follow-up
  11. Regulatory communication
  12. Lessons from past audits
Module 10. Team Leadership in CDISC Projects
Lead cross-functional teams through complex submissions. Learn how to align data managers, programmers, and statisticians around common standards and timelines.
12 chapters in this module
  1. Team role definitions
  2. Project planning
  3. Timeline management
  4. Cross-functional alignment
  5. Stakeholder communication
  6. Risk tracking
  7. Milestone setting
  8. Status reporting
  9. Conflict resolution
  10. Remote team coordination
  11. Performance metrics
  12. Leadership best practices
Module 11. Advanced SDTM Applications
Handle complex domains like AE, Labs, and ECG with precision. Learn how to structure datasets for maximum clarity and compliance, especially in high-risk therapeutic areas.
12 chapters in this module
  1. AE domain structure
  2. Labs and vitals
  3. ECG data handling
  4. Concomitant meds
  5. Medical history
  6. Exposure datasets
  7. Events and visits
  8. Supplemental domains
  9. Non-standard domains
  10. Therapeutic area specifics
  11. Data pooling strategies
  12. Domain integration
Module 12. Sustaining Compliance at Scale
Build a long-term compliance program that evolves with regulatory changes. Learn how to institutionalize best practices, update standards, and maintain audit readiness across multiple studies.
12 chapters in this module
  1. Compliance governance
  2. Standards versioning
  3. Update processes
  4. Training programs
  5. Knowledge transfer
  6. Vendor oversight
  7. Internal audits
  8. Performance dashboards
  9. Feedback loops
  10. Regulatory monitoring
  11. Continuous improvement
  12. Scaling across portfolios

How this maps to your situation

  • Regulatory shifts in China requiring CDISC alignment
  • Increased NMPA scrutiny on data structure and metadata
  • Growing need for automation in submission workflows
  • Leadership role in CDISC China driving standards adoption

Before vs. after

Before
Manual, inconsistent submission processes, frequent validation failures, and audit exposure due to poor traceability and metadata gaps.
After
Streamlined, automated, and fully compliant submission workflows with audit-ready documentation and team-wide alignment on CDISC standards.

What's included with your purchase

  • 12 modules with 12 chapters each (144 chapters)
  • Downloadable templates and worked examples for every module
  • Hand-built implementation playbook delivered alongside course access
  • 30-day money-back guarantee

Delivery and format

  • Course and learning environment access provisioned within 24 hours of purchase
  • Hand-built implementation playbook delivered alongside course access

Format: Text-based modules and chapters in the Art of Service learning environment, plus downloadable templates and worked examples for every chapter, plus the hand-built implementation playbook delivered alongside course access.

Time investment: Approximately 3-4 hours per module, designed for flexible, self-paced learning over 6-8 weeks.

If nothing changes
Continuing with inconsistent CDISC implementation increases the risk of submission rejection, regulatory delays, and audit findings , especially as NMPA tightens enforcement. Without standardized processes, teams waste time on rework, and leadership loses credibility with sponsors and regulators.

How this compares to the alternatives

Unlike generic CDISC training, this course is tailored to China’s regulatory context, with real-world examples, automation frameworks, and leadership strategies for compliance at scale , not just theory, but implementation.

Frequently asked

Is this course relevant for teams submitting only to NMPA?
Yes. The course covers both NMPA and FDA expectations, with specific guidance for NMPA-only submissions and how to adapt for dual submissions.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Are the templates customizable?
Yes. All templates are provided in editable formats and can be adapted to your organization’s standards.
$199 one-time. Approximately 3-4 hours per module, designed for flexible, self-paced learning over 6-8 weeks..

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.

30-day money-back guarantee· 144 chapters· Hand-built playbook included· Account access within 24 hours
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