New
SM
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...
QMS Foundations for Clinical Sites Course & Certification
Professional
Watch Preview
4.8
★★★★★
97% Recommended
Updated 2026
2 hour
189 active users
3 points
Watch Preview
Your Study Basket
1 x QMS Foundations for Clinical Sites
| Total | |
🎁 FREE Bonus Included
eBookWorth £29— Yours FREE when you purchase today.
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
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
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
The QMS Foundations for Clinical Sites Course is designed to provide a clear understanding of Quality Management Systems (QMS) in clinical research settings. The course focuses on building a strong foundation in quality processes that ensure compliance, consistency, and reliability in clinical trial conduct at investigator sites.
This course covers QMS principles, standard operating procedures (SOPs), deviation management, CAPA (Corrective and Preventive Actions), training systems, audit readiness, and quality risk management. It also emphasizes Good Clinical Practice (GCP) compliance and regulatory expectations for clinical site operations. Upon successful completion, learners receive a certification demonstrating competency in clinical site quality management systems.
Who Should Enrol?
- Clinical Research Professionals
- Clinical Trial Coordinators and Managers
- Clinical Research Associates (CRAs)
- Principal Investigators and Study Teams
- Quality Assurance and Compliance Professionals
- Regulatory Affairs Professionals
- Pharmaceutical, Biotechnology, and CRO Employees
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of Quality Management Systems (QMS) in clinical research settings, including regulatory expectations, governance, and building a strong quality culture.
Learn essential QMS processes such as SOP development, deviation management, change control, and CAPA implementation to ensure consistent compliance.
Gain knowledge of training management and staff qualification requirements, including training matrices, GCP certification, and delegation of responsibilities.
Develop an understanding of continuous quality improvement through self-inspections, monitoring activities, audit readiness, and effective collaboration with clinical monitors.
Course Syllabus
- What Is a Quality Management System?
- Regulatory Basis & Requirements
- Building Your Site QMS
- Quality Culture & Governance
- Writing Effective SOPs
- SOP Governance
- Deviation Classification & Reporting
- CAPA Fundamentals for Clinical Sites
- Why Training Management Is a GCP Requirement
- The Training Matrix
- GCP Certification Requirements & Maintenance
- Delegation of Responsibilities
- What Is Self-Inspection and Why Is It Required
- Planning and Scheduling Self-Inspections
- Conducting a Self-Inspection
- Managing Self-Inspection Findings
- The Monitor's Role in Clinical Research
- What the Monitor Checks — Before, During & After
- CRF Completion, Data Quality & Audit Trails
- Close-Out & Post-Trial Monitoring
- Business Continuity Planning for Clinical Sites
- 📘 Bonus: QMS Foundations for Clinical Sites eBook (Free with purchase)
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Frequently Asked Questions
This course introduces the core principles of Quality Management Systems tailored for clinical research sites. It explains how to develop and maintain structured processes that support compliance, data integrity, and subject safety in alignment with GCP guidelines.
In this course, you will learn how to:
- Fundamentals of Quality Management Systems (QMS) in clinical research
- Key GCP requirements related to quality at clinical sites
- Development and management of SOPs and controlled documents
- Risk-based thinking and quality risk management principles
- Handling deviations, CAPAs, and quality issues
- Documentation best practices and data integrity principles
- Continuous improvement and inspection readiness strategies
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 .
- Improve compliance with GCP and regulatory requirements
- Enhance documentation quality and data integrity
- Effectively manage deviations and implement CAPAs
- Strengthen inspection readiness and audit performance
- Promote a culture of quality and continuous improvement
