Program Structure

Module 1: GCP in Real Life (What It Protects and What It Prevents)

• Why GCP exists: participant rights, safety, and trustworthy results.
• How poor compliance shows up in the real world: data issues, ethics issues, and trial delays.
• The clinical trial ecosystem: how sponsors, CROs, sites, labs, and regulators connect.

Module 2: ICH-GCP E6 (R3) Overview and Key Updates

• Understanding the structure of E6 (R3) and how it aligns with modern trials.
• Risk-based thinking: focusing effort where errors can harm participants or data integrity.
• Why quality management is a daily habit, not just an audit checklist.

Module 3: Roles and Responsibilities (Who Does What and Where Mistakes Happen)

• Investigator responsibilities and what regulators expect at a clinical site.
• Sponsor and CRO responsibilities: oversight, delegation, and vendor control.
• Monitors, data managers, and study coordinators: how each role prevents risk.
• How delegation logs, training records, and supervision protect the study and the team.

Module 4: Ethics Committee and Participant Protection

• Ethics committee review: why protocols, consent forms, and amendments need approval.
• Participant rights and confidentiality: what you must do and what you must never do.
• Handling vulnerable populations with extra care and clear documentation.

Module 5: Informed Consent Process (More Than a Signature)

• How to conduct a proper consent conversation in a respectful, understandable way.
• Documentation essentials: version control, dates, signatures, and required elements.
• Common consent mistakes that create serious findings in audits.
• Consent in remote or digital settings: what to check before you proceed.

Module 6: Protocol, Source Data, and Essential Documentation

• Protocol compliance: what counts as a deviation and how to handle it correctly.
• Source documents vs CRFs: what must match and how to avoid data integrity issues.
• Essential documents and the logic behind TMF and ISF filing.
• ALCOA+ concepts in simple terms: making data trustworthy and inspection-ready.

Module 7: Safety Reporting and Pharmacovigilance Basics

• Adverse events, serious adverse events, and what needs rapid escalation.
• How causality, expectedness, and severity are assessed in practical workflows.
• Reporting responsibilities at sites and sponsor/CRO teams.
• Safety narratives and follow-ups: what good documentation looks like.

Module 8: Quality Management and Risk-Based Monitoring

• Quality by design: planning trial processes to prevent errors from the beginning.
• Risk identification and control: what “critical to quality” means in daily work.
• Monitoring approaches: on-site, remote, centralized monitoring, and when to use each.
• CAPA basics: how to fix root causes, not just symptoms.

Module 9: Computerized Systems, Data Privacy, and Modern Trial Tools

• Electronic systems in trials: EDC, eTMF, ePRO, wearables, and data flow awareness.
• Computer system validation basics: what “validated” actually means for compliance.
• Privacy and confidentiality: handling participant data responsibly across systems and teams.

Module 10: Audits, Inspections, and Inspection Readiness

• What auditors and inspectors typically look for at sites and sponsor/CRO operations.
• How findings happen: missing documents, poor training records, inconsistent data, and delayed reporting.
• How to prepare calmly: checklists, self-inspections, and smart documentation habits.
• How to respond to findings professionally and write useful CAPAs.

Final Project

• Work through a realistic trial scenario and create a GCP-compliant action plan.
• Prepare a mini documentation pack: consent flow, deviation handling, safety reporting route, and quality checks.
• Example projects: Site readiness plan for a new study, audit-prep checklist for ISF/TMF, or risk assessment and monitoring plan.