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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 Research Associate Essentials (ICH GCP E6 R3 Aligned) Course & Certification
Intermediate
4.6
★★★★★
96% Recommended
Updated 2026
2 hours
187 active users
2 points
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1 x Clinical Research Associate Essentials (ICH GCP E6 R3 Aligned)
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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 Research Associate (CRA) role is central to the successful conduct of clinical trials, ensuring that studies are performed in compliance with Good Clinical Practice (GCP), regulatory requirements, and study protocols. CRAs play a key role in monitoring clinical sites, verifying data accuracy, ensuring patient safety, and maintaining the integrity of clinical trial data.
This Clinical Research Associate (CRA) Course & Certification provides a comprehensive foundation in clinical trial monitoring and site management. The course covers GCP principles, trial documentation, site selection and initiation, monitoring visits, source data verification, safety reporting, and study close-out activities. It also focuses on regulatory compliance, communication with investigators, and inspection readiness. Upon completion, learners receive a certification demonstrating their readiness to support clinical trials as a professional CRA.
Who Should Enrol?
- Aspiring Clinical Research Associates (CRAs)
- Clinical Research Coordinators (CRCs)
- Life Science, Pharmacy, Nursing, and Medical Graduates
- Clinical Trial Assistants and Study Coordinators
- Professionals transitioning into clinical research
- Pharmaceutical and CRO employees involved in clinical operations
- Regulatory Affairs and Quality Assurance personnel
- Anyone seeking a career in clinical trial monitoring
What you will learn
Understand the clinical research process, drug development lifecycle, and the roles and responsibilities of a Clinical Research Associate (CRA) in conducting and monitoring clinical trials.
Learn Good Clinical Practice (GCP), ICH guidelines, ethical principles, informed consent requirements, and global regulatory standards governing clinical research.
Develop practical skills in site monitoring, source data verification (SDV), trial documentation review, protocol compliance, and management of essential clinical trial records.
Gain knowledge of adverse event reporting, clinical trial quality management, audit and inspection readiness, and compliance requirements to ensure data integrity and participant safety.
Course Syllabus
- Overview of clinical trial phases, stakeholders, and regulatory landscape
- Responsibilities, core competencies, and professional expectations
- Ethical principles, participant protection, and updated GCP framework
- Feasibility assessments, site qualification visits, and essential documents
- Purpose of monitoring, communication pathways, and monitoring plans
- Ensuring data accuracy, completeness, and ALCOA+ principles
- Centralized vs. on-site monitoring, risk indicators, and QTLs
- Accountability, storage requirements, and handling procedures
- Identification, documentation, escalation, and regulatory timelines
- Identifying non-compliance, CAPA processes, and communication strategies
- Digital systems, remote SDV, virtual visits, and data protection
- Verification of completeness, transfer of responsibilities, and record retention
- Skills development, certification pathways, and industry expectations
- 📘 Bonus: Clinical Research Associate Essentials eBook (Free with purchase)
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Frequently Asked Questions
CRA roles are central to the success of clinical trials, requiring strong analytical skills, meticulous attention to detail, and a deep understanding of Good Clinical Practice (GCP). This course equips learners with the knowledge and confidence needed to perform effective site monitoring, assess data quality, oversee investigator activities, and maintain participant safety across all phases 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 CRA training with global recognition
- Fully updated to ICH GCP E6 (R3) requirements
- Ideal for aspiring CRAs and those transitioning from site roles
- Practical, scenario-based learning to build real-world confidence
- Certificate issued upon successful completion
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