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Clinical Data Management Practitioner Certification Part 2 (Advanced Practitioner Level) Course & Certification
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1 x Clinical Data Management Practitioner Certification Part 2 (Advanced Practitioner Level)
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Each course includes:
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CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ICH E6(R3) and E8(R1), CDISC SDTM, ADaM and CDASH,
SCDM GCDMP, FDA 21 CFR Part 11, EU Annex 11, MHRA data-integrity guidance (ALCOA+) and TransCelerate
RBM/RBQM, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed as Whitehall Training editorial material reflecting practising
clinical-data-management, CDISC and risk-based monitoring discipline, so that learners can design,
specify, reconcile and map with confidence in real study work.
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About
Clinical Data Management Practitioner Certification Part 2 (Advanced Practitioner Level) provides an advanced and practical overview of the principles, processes, tools, and best practices required to manage high-quality clinical trial data throughout the study lifecycle.
This Clinical Data Management Practitioner Certification Part 2 (Advanced Practitioner Level) course provides in-depth knowledge of advanced clinical data management activities, including clinical database design, data collection and validation, edit checks, data cleaning, discrepancy and query management, medical coding, data review, external data integration, reconciliation, data transfers, data standards, data listings, data quality management, database lock, and study closeout. The course also covers advanced data governance and compliance requirements, including data integrity, electronic records, audit trails, quality risk management, documentation, change control, oversight, and inspection readiness. Learners will develop the practical knowledge required to identify and resolve complex data issues, maintain data quality and consistency, support efficient clinical trial operations, and ensure that clinical data are accurate, complete, reliable, and fit for analysis. Upon successful completion, learners receive a certification demonstrating their advanced understanding and practical application of clinical data management principles and processes.
Who Should Enrol?
- Clinical Data Management Professionals
- Clinical Data Managers and Senior Clinical Data Managers
- Clinical Research Associates and Clinical Research Professionals
- Clinical Operations and Study Management Professionals
- Data Review and Data Quality Professionals
- Medical Coding and Clinical Coding Professionals
- Database Programmers and Clinical Data Programmers
- Biostatistics and Statistical Programming Professionals
- Quality Assurance and GCP Compliance Professionals
- Clinical Research Organization (CRO) Professionals
- Pharmaceutical, Biotechnology, and Medical Device Professionals
- Professionals seeking advanced-level knowledge and certification in clinical data management
What you will learn
Build advanced knowledge of clinical data management principles, processes, and best practices, including study setup, data collection, database design, data standards, and data quality management across complex clinical trials.
Learn advanced approaches to clinical database design, data validation, edit checks, data cleaning, discrepancy management, coding, reconciliation, and review of clinical trial data to ensure accuracy, completeness, consistency, and reliability.
Develop practical expertise in advanced clinical data management activities, including external data integration, medical coding, data review, query management, data transfers, data standards, data listings, data reconciliation, and database lock and closeout processes.
Gain an understanding of advanced data governance, regulatory compliance, and inspection readiness in clinical data management, including data integrity, audit trails, electronic records, quality risk management, documentation, oversight, change control, and compliance with applicable clinical research standards.
Course Syllabus
- Field-level design principles — one fact per field, analysis-ready capture
- Control types & codelist reuse; CDASH alignment
- Hard vs soft edit checks — writing a specification
- Univariate vs cross-form / cross-visit checks
- CRF Completion Guidelines (CCG) & non-leading query wording
- Applied Exercise — design a Vital Signs eCRF page from an ORION-3 protocol excerpt
- The query lifecycle — generation, routing, response, re-query, resolution, closure
- System vs manual queries; audit-trail expectations
- Discrepancy triage & prioritisation — safety / lock-critical first
- Writing clear, non-leading queries
- SLAs, ageing buckets and query metrics
- Applied Exercise — triage and resolve a batch of simulated ORION-3 discrepancies
- The lock-readiness checklist domains
- SAE / AE reconciliation against the safety database
- Soft (freeze) vs hard lock
- Post-lock amendment & controlled-unlock procedure with change control
- Roles, sign-offs and the lock meeting
- Applied Exercise — walk a lock-readiness checklist against a mock study
- Module intro — what this standalone module covers and who it's for
- Common EDC anatomy — study library, forms / folders, roles, audit trail
- Medidata Rave (representative workflow)
- Veeva Vault CDMS (representative workflow)
- Oracle InForm / Clinical One (representative workflow) & migration context
- Platform comparison for CRO standardisation / migration decisions
- Applied Exercise — data-entry + query workflow walk-through, mapped across platforms
- Module intro — what this standalone module covers and who it's for
- The CDISC pipeline — CDASH → SDTM → ADaM → define.xml
- SDTM structure — observation classes, domains, variable roles, controlled terminology
- Variable-level mapping practice; ISO 8601 dates and units
- ADaM analysis-ready construction — ADSL, BDS, traceability, analysis flags
- Common mapping errors & submission-readiness pitfalls
- Applied Exercise — map a small raw dataset to SDTM domains
- RBDM principles & the ICH E6(R3) / E8(R1) quality-by-design link
- Identifying critical data and processes
- KRIs vs KQIs — thresholds, signals and actions
- Central Statistical Monitoring (CSM) — digit preference, low variance, outliers
- Targeted vs 100% SDV decision framework
- Applied Exercise — apply a targeted-SDV decision framework to a KRI dashboard
- Brief — run a compressed ORION-3 sub-study end to end (LO1–LO7)
- Stage 1 — design a Vital Signs eCRF page + edit checks + CCG note
- Stage 2 — enter two subjects & resolve a query batch, including a leading query
- Stage 3 — run the lock-readiness checklist, SAE / AE reconciliation, decide soft / hard lock
- Deliverable — a completed lock-readiness package to keep as a work sample
- How the pieces fit — the end-to-end CDM lifecycle
- Learning path & next steps — foundations, Biostatistics, PV-Systems (Oracle Argus)
- Final Evaluation — capstone-linked scenario items (35 questions, 80% pass)
- The CDM Practitioner Certificate
- Sources & standards register
- 📘 Bonus: Clinical Data Management Practitioner Certification Part 2 (Advanced Practitioner Level) eBook (Free with purchase)
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Frequently Asked Questions
This course provides advanced knowledge of clinical data management principles, processes, and best practices across the clinical trial lifecycle. It focuses on advanced data collection, database design, data validation, data cleaning, coding, reconciliation, data review, data integration, and database lock activities while emphasizing data quality, integrity, regulatory compliance, and inspection readiness.
In this course, you will learn how to:
- Apply advanced clinical data management principles throughout the clinical trial lifecycle
- Design and manage clinical databases, edit checks, and data validation processes
- Perform advanced data cleaning, query management, data review, and discrepancy resolution
- Understand medical coding, external data integration, data reconciliation, and data transfers
- Apply clinical data standards and data quality management practices
- Manage database lock, study closeout, and final data review activities
- Maintain data integrity, audit trails, documentation, and regulatory compliance
- Support audit, inspection, and regulatory readiness through effective data management practices
This course is ideal for individuals who want to develop or advance their expertise in clinical data management and clinical research, including:
- Clinical data management professionals seeking advanced knowledge
- Clinical data managers and clinical research professionals
- Clinical research associates and clinical operations professionals
- Data review, data quality, and medical coding professionals
- Database programmers and clinical data programmers
- Biostatistics and statistical programming professionals
- Quality assurance and GCP compliance professionals
- Professionals working in pharmaceutical, biotechnology, CRO, or medical device organizations
- Anyone seeking advanced practitioner-level knowledge and certification in clinical data management
- Develop advanced expertise in clinical data management processes and practices
- Strengthen skills in data validation, cleaning, review, reconciliation, and quality management
- Enhance understanding of clinical database design, data standards, and data integration
- Improve knowledge of database lock and study closeout activities
- Strengthen awareness of data integrity, regulatory compliance, and inspection readiness
- Build practical advanced-level knowledge for careers in clinical data management and clinical research
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