Curriculum
- 4 Sections
- 25 Lessons
- 1 Day
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- Introduction to Good Clinical Practice6
- 1.1Overview of GCP: Understanding the origins and evolution of GCP (ICH E6 Guidelines).
- 1.2Ethical considerations and the Declaration of Helsinki.
- 1.3Definitions: Subject, Sponsor, Investigator, CROs, and IRBs/IECs.
- 1.4Regulatory Framework: FDA, EMA, and local regulations.
- 1.5Understanding why GCP compliance is critical for trial success.
- 1.6Impact of non-compliance cases in clinical trials.
- Roles, Responsibilities, and Stakeholders in GCP7
- 2.1Sponsors, Monitors, and Investigators.
- 2.2Clinical Research Organizations (CROs) and their role in GCP.
- 2.3Institutional Review Boards (IRBs) and Ethics Committees.
- 2.4Investigator site practices and record-keeping.
- 2.5Safety reporting and adverse event management.
- 2.6Case Scenarios: How misalignment in roles can impact trial outcomes.
- 2.7Interactive Exercise: Role-based problem-solving exercise on stakeholder conflicts.
- GCP in Action - Managing Clinical Trial Processes8
- 3.1Study Protocol and Investigatorās Brochure.
- 3.2Informed Consent Process and Documentation.
- 3.3Source Data, Case Report Forms (CRFs), and Data Integrity.
- 3.4Audit Trails and Quality Assurance.
- 3.5Risk-Based Monitoring (RBM), Inspection Readiness, Data Privacy (GDPR), Good Documentation Practice (GDP).
- 3.6Best practices and challenges faced during trial audits.
- 3.7Situational case studies: Ensuring subject safety and data quality.
- 3.8Interactive Exercise: Audit Simulation ā Identifying gaps in compliance in a mock trial scenario.
- Common Challenges and Real-World Problem Solving4
- 4.1Balancing timelines, costs, and compliance.
- 4.2Ensuring patient safety and ethical conduct in multi-center trials.
- 4.3Case Studies: Addressing protocol deviations; Managing data discrepancies; Ensuring consistent GCP adherence in global trials.
- 4.4Insights on handling regulatory inspections and deviations.