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About

The Clinical Study Coordinator Course by Whitehall Training provides a comprehensive foundation for entry-level professionals and focuses on the practical execution of clinical trials within the framework of Good Clinical Practice. Core content typically covers GCP fundamentals (principles, ethics, and regulatory requirements), the global regulatory landscape and ethics committee oversight, investigator and sponsor responsibilities, and clinical trial documentation and data integrity (including ALCOA+ principles, source data, CRFs, and site files). It also includes safety and pharmacovigilance processes (AE, SAE, and SUSAR reporting), protocol understanding and trial conduct, monitoring and site operations (including CRA roles and source data verification), and data governance using electronic systems and audit trails. Additional topics include informed consent procedures, investigational product management, quality and risk-based approaches, and study close-out and record retention. These topics are drawn from international guidelines – notably ICH-GCP E6(R3) and related regulatory frameworks. The course emphasizes practical, inspection-ready skills (e.g. maintaining study documentation, supporting informed consent, managing safety reporting, and ensuring protocol compliance) in line with global regulatory standards.

Course Syllabus

  1. What is Good Clinical Practice (GCP)?
  2. The History of Good Clinical Practice
  3. ICH E6(R3): Structure & Document Hierarchy
  4. The 11 Principles of ICH GCP
  5. Quality Assurance & Documentation in GCP
  6. Missing SOP — A Site Inspection Failure

  1. Global Regulatory Authorities
  2. Responsibilities of the Regulatory Authority
  3. Independent Ethics Committee (IEC): Structure & Composition
  4. IEC Responsibilities & Ongoing Review
  5. Informed Consent Form (ICF) — Content Requirements
  6. ICF: Plain Language & Special Populations
  7. Consent Obtained — But Was It Valid?

  1. The Principal Investigator — Role & Responsibilities Overview
  2. Qualifications, Resources & Delegation
  3. Medical Care of Trial Participants
  4. Protocol Compliance & Amendments
  5. Investigational Medicinal Product (IMP) Management at Site
  6. Randomisation & Blinding
  7. The Informed Consent Process — Step by Step
  8. Consent for Special Populations
  9. Study Site File (SSF) & Source Documents
  10. Records, CRFs & the ALCOA Principles
  11. Progress Reports, Archiving & Record Retention
  12. Protocol Deviation — The Wrong Dose

  1. The Sponsor — Definition, Role & Key Responsibilities
  2. Quality Management & Risk-Based Approach (ICH E6 R3)
  3. Delegation to Contract Research Organisations (CROs)
  4. IMP Supply Chain & Labelling
  5. CRO Handover — Who's Responsible Now?

  1. ALCOA+ Principles of Data Governance
  2. Electronic Data Capture (EDC) & Audit Trails
  3. Data Fabrication — The Consequences

  1. The Clinical Research Associate (CRA / Monitor)
  2. Types of Site Visits — The Monitoring Visit Lifecycle
  3. Source Data Verification (SDV) & Monitoring Reports
  4. The Missing Consent — A Critical Finding

  1. Adverse Events — Definitions & Classifications
  2. SAE Reporting Process & Timelines
  3. SUSARs & Periodic Safety Reporting
  4. AE/SAE Classification & Reporting Flowchart
  5. SAE Reported 10 Days Late — Consequences

  1. Clinical Trial Protocol — Structure & Content
  2. Protocol Amendments — Types, Processes & Examples

  1. Investigator's Brochure (IB)

  1. Essential Records — Before, During & After the Trial

  1. Key GCP Terms & Abbreviations
  2. 12 Things Every CSC Level 1 Must Know

  1. Useful Documents & Key References

Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Frequently Asked Questions

The Clinical Trial Project Management Course by Whitehall Training provides a comprehensive foundation for professionals and combines standard project management methods with the specialized context of clinical research.

  • The fundamentals of clinical research and trial phases and core responsibilities and day-to-day tasks of a CRA
  • Key ICH GCP E6(R3) principles and regulatory expectations
  • How to prepare for and conduct monitoring visits
  • Risk-based and remote monitoring approaches
  • Investigational Product (IP) oversight and accountability
  • Safety reporting requirements (AE/SAE/SUSAR)
  • Site communication, documentation, and issue escalation
  • Close-out procedures and essential record archiving

This course is ideal for individuals who want to begin or advance a career in clinical research, including:

  • Aspiring Clinical Research Associates (CRAs)
  • Clinical trial site staff transitioning into monitoring roles
  • Clinical Research Coordinators (CRCs) seeking career progression
  • Professionals working in pharmaceutical, biotech, or CRO environments
  • Anyone seeking a strong foundation in monitoring, GCP, and site oversight .
No prior CRA experience is required, but familiarity with clinical research or GCP is helpful.

  • Industry-aligned CPM training with global recognition
  • Fully updated to ICH GCP E6 (R3) requirements
  • Ideal for aspiring CPMs and those transitioning from site roles
  • Practical, scenario-based learning to build real-world confidence
  • Certificate issued upon successful completion