Regulated Science Institute

Syllabus

ICH E6(R3) Good Clinical Practice Implementation Professional Certificate

29 lessons, about 10 hours. Online and self-paced, with a certificate when you finish.

ICH E6(R3) Framework

Establish the revised GCP framework, its operational differences from E6(R2), and the distinctions between international adoption and regional regulatory implementation.

  1. 1E6(R2) to E6(R3) Structural Changes
  2. 2The Eleven GCP Principles
  3. 3ICH Adoption and Regional Implementation
  4. 4Clinical Trial Regulatory Applicability

Stakeholder Responsibilities

Translate GCP responsibilities into documented operational accountability, effective investigator oversight, independent ethical review and legally appropriate informed consent.

  1. 5Sponsor and Investigator Responsibilities
  2. 6Delegation and Regulatory Obligation Transfer
  3. 7IRB Oversight and Informed Consent

Quality by Design

Translate scientific objectives into critical-to-quality factors, measurable trial risks, proportionate controls and operationally feasible protocol requirements.

  1. 8Critical-to-Quality Factor Identification
  2. 9Trial Risk Assessment and Prioritization
  3. 10Proportionate Risk Controls and Thresholds
  4. 11Protocol Quality and Operational Review

Oversight and Vendors

Build proportionate monitoring and site oversight arrangements that maintain investigator accountability, sponsor control and documented CRO and service-provider performance.

  1. 12Risk-Based Monitoring Strategies
  2. 13Monitoring Signals and Corrective Actions
  3. 14Investigator Delegation and Site Oversight
  4. 15CRO and Service Provider Oversight

Data Governance and Systems

Apply lifecycle-based data governance, data-integrity controls and fit-for-purpose computerized-system practices to maintain trustworthy clinical trial records.

  1. 16Clinical Trial Data Governance
  2. 17Source Data and Data Traceability
  3. 18Computerized Systems and Part 11
  4. 19Data Quality Investigations and CAPA

Trial Conduct and Safety

Apply GCP to everyday trial execution, investigational product management, participant safety reporting and technology-enabled clinical trial designs.

  1. 20Protocol Compliance and Product Management
  2. 21Investigator and Sponsor Safety Reporting
  3. 22Decentralized and Pragmatic Trial Designs
  4. 23Technology-Enabled Participant Protection

Essential Records and Inspection

Organize essential clinical trial records, apply jurisdiction-specific retention requirements and demonstrate inspection readiness through complete, traceable evidence.

  1. 24Essential Records and TMF Structure
  2. 25Retention and Record Lifecycle Management
  3. 26Regulatory Inspection Preparation
  4. 27Inspection Evidence and Personnel Readiness

Implementation Capstone

Integrate the revised GCP framework into an end-to-end clinical trial assessment, producing practical remediation deliverables and an evidence-based implementation plan.

  1. 28E6(R2)-to-E6(R3) Gap Assessment
  2. 29Integrated GCP Implementation Simulation
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