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About

This course by Whitehall Training provides an overview of clinical data management and Good Clinical Practice (GCP), including ethical principles such as the Declaration of Helsinki and the ICH E6 principles. It covers key topics like subject rights, informed consent, data integrity (ALCOA+), and confidentiality, along with the clinical research landscape and the NIH 4-question framework. The course also explains trial phases (I–IV), study design elements like randomisation and blinding, and introduces basic concepts of clinical trial management systems (CTMS).

Course Syllabus

  1. The Declaration of Helsinki: Ethical Foundation
  2. What is Good Clinical Practice (GCP)?
  3. The 13 ICH E6 Principles: At a Glance
  4. ICH E6(R3): The Shift to Quality by Design

  1. Clinical Research: The Broad Landscape
  2. Clinical Trial vs. Clinical Research: Key Distinctions
  3. Research Taxonomy: Where Does Your Study Fit?
  4. The Research Protocol: Master Document of Every Trial
  5. Sponsor Accountability: Responsibilities Under GCP
  6. The NIH 4-Question Framework: Is It a Clinical Trial?
  7. Investigator Accountability: The PI's Legal Obligations
  8. The IRB/IEC: Independent Ethical Review
  9. Informed Consent: Process, Elements & Documentation
  10. Subject Rights & Protections in Clinical Research
  11. Study Design Fundamentals: Building the Scientific Framework
  12. Blinding & Randomisation: Eliminating Bias

  1. The Phased Approach: Purpose and Scientific Logic
  2. Pre-Clinical Development: Building the Safety Case
  3. Phase I: Safety, Tolerability & First-in-Human Studies
  4. Phase I: Single Ascending Dose (SAD) Study Design
  5. Phase I: Multiple Ascending Dose (MAD) Study Design​
  6. Maximum Tolerated Dose (MTD) & Dose-Limiting Toxicity (DLT)
  7. Pharmacokinetics (PK) & Pharmacodynamics (PD)
  8. Phase II: Therapeutic Exploratory & Efficacy Studies
  9. Proof of Concept & Adaptive Trial Designs
  10. Phase III: Pivotal Confirmatory Evidence
  11. Phase III: RCT Design, Endpoints & Analysis Populations
  12. Phase III: Statistical Power & Sample Size Justification
  13. Phase III: Global Multi-Centre Trial Complexity
  14. Phase IV: Post-Market Surveillance Studies
  15. Pharmacovigilance: Protecting Patients After Approval
  16. Bioequivalence (BE) Studies: The Pathway for Generics
  17. BE Studies: Understanding AUC, Cmax, and Tmax
  18. Clinical Trials in Special Populations
  19. Oncology Trials: Unique Design & Regulatory Nuances
  20. Decentralised Clinical Trials (DCTs) & Real-World Evidence

  1. What is Clinical Trial Management (CTM)?
  2. CTM vs. CDM: The Critical Operational Distinction
  3. The Business Case for a Clinical Trial Management System
  4. CTMS Core Module 1: Site Management
  5. CTMS Core Module 2: Subject Tracking & Enrolment
  6. CTMS Core Module 3: Financial & Budget Management
  7. CTMS Core Module 4: Monitoring Event Management
  8. CTMS Vendor Evaluation: A Structured Framework
  9. Key Regulatory Requirements for Electronic Trial Systems
  10. Cloud vs. On-Premise CTMS: Architecture Decision
  11. The eClinical Ecosystem: System Integration
  12. CTMS Outputs: Reports That Drive Decision-Making

  1. What is Clinical Data Management?
  2. The CDM Lifecycle: End-to-End Overview
  3. Study Start-Up: Protocol Review & the DMP
  4. Data Management Plan: Key Components
  5. CRF Design: Core Principles
  6. Electronic CRFs (eCRF): Design Best Practices
  7. CRF Completion Guidelines (CCG)
  8. Database Design, Build & User Acceptance Testing
  9. Edit Checks: Types, Logic & Classification
  10. Edit Check Specifications & Programming
  11. External Data Sources & Third-Party Data Management
  12. External Data Reconciliation Process
  13. Data Entry: Single Entry vs Double Entry Verification
  14. Query Management: The Full Lifecycle
  15. Query Types & Response Time Standards
  16. Data Cleaning: Process, Checks & Key Metrics
  17. Medical Coding: MedDRA and WHO Drug
  18. Database Freeze, Review & Lock

  1. The CDM Team Structure
  2. The Data Manager: Role Deep-Dive
  3. Sponsor CDM vs CRO CDM: Models & Responsibilities
  4. Outsourcing CDM: Full-Service vs Functional Service Models
  5. CDM Study Timelines & Planning
  6. Risk-Based Data Management (RBDM)
  7. Central Statistical Monitoring (CSM)
  8. Source Data Verification: 100% SDV vs Targeted SDV
  9. CDM KPIs: Measuring Performance
  10. Data Privacy in Clinical Trials: GDPR & HIPAA
  11. Pseudonymisation, Anonymisation & Informed Consent
  12. ALCOA+ Data Integrity in CDM

  1. Computer System Validation (CSV): The Fundamentals
  2. The CSV Lifecycle: IQ, OQ, PQ
  3. GAMP5: Risk-Based Approach to CSV
  4. 21 CFR Part 11: Electronic Records & Electronic Signatures
  5. Audit Trails: Requirements & Review
  6. Access Controls & User Management in CDM Systems
  7. CSV Documentation: What You Must Have
  8. Change Control for Validated Systems
  9. Regulatory Inspection Readiness: CDM Perspective
  10. Common CDM Findings in Regulatory Inspections

  1. CDM Quality Management System
  2. CDISC Standards: The Submission Data Language
  3. SDTM in Practice: Domains, Variables & Mapping
  4. ADaM: Analysis-Ready Datasets for Biostatistics
  5. Protocol Deviation Management in CDM
  6. EDC Platform Landscape: Key Systems in CDM
  7. CDM in Decentralised & Hybrid Clinical Trials
  8. Emerging Technologies: AI & Automation in CDM
  9. Top 10 CDM Mistakes — and How to Avoid Them

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Frequently Asked Questions

The Clinical Data Management course by Whitehall Training provides a foundational understanding of Good Clinical Practice (GCP), clinical research, trial phases, and clinical trial management systems, focusing on ethical principles, regulatory requirements, study design, and trial operations.

  • Foundations of Good Clinical Practice (GCP) and the Declaration of Helsinki
  • The 13 ICH E6 principles including subject rights, safety, and data integrity (ALCOA+)
  • Overview of clinical research and differences between clinical research and clinical trials
  • NIH 4-question framework to identify a clinical trial
  • Study design fundamentals including randomisation and blinding
  • Understanding clinical trial phases from Phase I to Phase IV
  • Role and importance of IRB/IEC approval in clinical trials
  • Introduction to Clinical Trial Management Systems (CTMS) and their core functions

This course is ideal for individuals involved in clinical research and trial operations, including:

  • Principal Investigators (PIs)
  • Clinical Data Managers
  • Clinical research site teams
  • Professionals involved in clinical trial design and conduct
  • Anyone seeking foundational knowledge of GCP, clinical research, and trial phases
No prior advanced experience is required, but a basic understanding of clinical research concepts is helpful.

  • Strong foundation in Good Clinical Practice (GCP) and ethical principles
  • Clear understanding of the 13 ICH E6 principles and their practical application
  • Comprehensive overview of clinical research and trial phases (I–IV)
  • Introduction to study design concepts such as randomisation and blinding
  • Understanding of regulatory requirements including IRB/IEC approval
  • Basic knowledge of Clinical Trial Management Systems (CTMS) and trial operations