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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
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...
Clinical Study Coordinator Level 1 Course & Certification
Beginner
4.7
★★★★★
96% Recommended
Updated 2026
1 hour
179 active users
3 points
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1 x Clinical Study Coordinator Level 1
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Each course includes:
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
Fully compliant
This course meets the required standard for basic GCP training, allowing learners to work on clinical trials. Learners also receive 6 Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
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About
The Clinical Study Coordinator Level 1 Course is designed to provide foundational knowledge of clinical research operations and the essential responsibilities of a study coordinator at the clinical trial site. It introduces the core principles of Good Clinical Practice (GCP), clinical trial conduct, and day-to-day site management activities required to support high-quality and compliant research.
This course covers key areas such as study start-up activities, participant recruitment and screening, informed consent process, source documentation, data entry into case report forms (CRFs), adverse event reporting, and coordination with investigators, sponsors, and study monitors. It also emphasizes regulatory compliance, essential documentation, and basic quality and safety requirements in clinical trials. Upon completion, learners will receive a certification demonstrating their readiness to contribute effectively as a Clinical Study Coordinator at the entry level.
Who Should Enrol?
- Aspiring Clinical Study Coordinators
- Clinical Research Coordinators (entry-level)
- Clinical Trial Assistants (CTAs)
- Life Science, Pharmacy, Nursing, and Medical Graduates
- Hospital and Clinic Staff involved in Research Support
- Professionals transitioning into clinical research operations
- Students seeking a career in clinical trial site management
What you will learn
Understand the fundamentals of Good Clinical Practice (GCP), including ICH E6 (R3) principles, regulatory framework, documentation requirements, and roles of key stakeholders in clinical trials.
Learn essential site-level responsibilities, including investigator oversight, informed consent process, protocol compliance, IMP handling, and proper maintenance of study documents and source records.
Gain knowledge of clinical trial operations such as sponsor and monitor responsibilities, CRO interactions, monitoring activities, data governance, safety reporting, and adherence to ALCOA+ data integrity principles.
Develop practical awareness of trial execution risks, including protocol deviations, audit findings, essential record management, and inspection readiness to ensure compliance and participant safety.
Course Syllabus
- What is Good Clinical Practice (GCP)?
- The History of Good Clinical Practice
- ICH E6(R3): Structure & Document Hierarchy
- The 11 Principles of ICH GCP
- Quality Assurance & Documentation in GCP
- Missing SOP — A Site Inspection Failure
- Global Regulatory Authorities
- Responsibilities of the Regulatory Authority
- Independent Ethics Committee (IEC): Structure & Composition
- IEC Responsibilities & Ongoing Review
- Informed Consent Form (ICF) — Content Requirements
- ICF: Plain Language & Special Populations
- Consent Obtained — But Was It Valid?
- The Principal Investigator — Role & Responsibilities Overview
- Qualifications, Resources & Delegation
- Medical Care of Trial Participants
- Protocol Compliance & Amendments
- Investigational Medicinal Product (IMP) Management at Site
- Randomisation & Blinding
- The Informed Consent Process — Step by Step
- Consent for Special Populations
- Study Site File (SSF) & Source Documents
- Records, CRFs & the ALCOA Principles
- Progress Reports, Archiving & Record Retention
- Protocol Deviation — The Wrong Dose
- The Sponsor — Definition, Role & Key Responsibilities
- Quality Management & Risk-Based Approach (ICH E6 R3)
- Delegation to Contract Research Organisations (CROs)
- IMP Supply Chain & Labelling
- CRO Handover — Who's Responsible Now?
- ALCOA+ Principles of Data Governance
- Electronic Data Capture (EDC) & Audit Trails
- Data Fabrication — The Consequences
- The Clinical Research Associate (CRA / Monitor)
- Types of Site Visits — The Monitoring Visit Lifecycle
- Source Data Verification (SDV) & Monitoring Reports
- The Missing Consent — A Critical Finding
- Adverse Events — Definitions & Classifications
- SAE Reporting Process & Timelines
- SUSARs & Periodic Safety Reporting
- AE/SAE Classification & Reporting Flowchart
- SAE Reported 10 Days Late — Consequences
- Clinical Trial Protocol — Structure & Content
- Protocol Amendments — Types, Processes & Examples
- Investigator's Brochure (IB)
- Essential Records — Before, During & After the Trial
- Key GCP Terms & Abbreviations
- 12 Things Every CSC Level 1 Must Know
- Useful Documents & Key References
- 📘 Bonus: Clinical Study Coordinator Level 1 eBook (Free with purchase)
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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 .
- 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
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