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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 3
Intermediate4.7
★★★★★
97% Recommended
Updated 2026
3 hours
0 active users
2 points
Bundle Offer: Accelerate Your Clinical Research Career - Master Good Clinical Practice (ICH GCP E6(R3)) + Fundamentals of Clinical Trials + AI in Clinical Research in one high-impact bundleYour Study Basket
1 x Clinical Study Coordinator Level 3
| Total |
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Each course includes:
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited 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.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ICH GCP E6(R3), FDA 21 CFR 312, EMA CTR 536/2014, MHRA inspection priorities and ICH safety reporting guidelines, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by senior Clinical Study Coordinators and site managers to ensure that learners can lead complex trials with confidence.
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About
This course is recommended for senior or lead Clinical Study Coordinators, study managers, and CRC/CSC leads moving into supervisory or trainer roles. On completion, learners will be able to lead source documentation strategy, manage deviations and amendments, prepare a site for inspection, and coach junior CRCs on protocol-driven decision making. Aligned with ICH GCP E6(R3), FDA, EMA and MHRA expectations.
Course Syllabus
- From Coordinator to Site Leader
- Leadership Behaviours
- Cross-functional Mastery
- Advanced Operations
- Types of IRB / EC
- Review Types
- Submission Excellence
- Lifecycle Management
- Managing Delays & Recovery
- ALCOA+ Principles
- Essential Documents
- Inspection-grade Binder
- Common Pitfalls
- Delegation Log Mechanics
- Training Documentation
- Staff Change Management
- Delegation/Training Pitfalls
- Form 1572 — The Statement of Investigator
- Financial Disclosure
- Investigator Responsibilities (21 CFR 312)
- Common Audit Issues
- IP Receipt & Storage
- Dispensing & Subject Use
- Cold Chain & Excursions
- End-of-Trial Reconciliation
- What is a Protocol Deviation
- Root-Cause Analysis
- CAPA — Corrective & Preventive Action
- Trending & Patterns
- Assessing Adherence
- Managing Non-Compliance
- Data Integrity & Compliance
- Special Populations
- Types of Audit & Inspection
- Top 10 Audit Findings
- Inspection-Day Choreography
- Always-Ready Posture
- Multiple-Study Management
- Coaching Junior CRCs
- Preventing Operational Failure
- Succession & Continuity
- Audit & Inspection Scenarios
- Deviation & CAPA Scenarios
- IP & Logistics Scenarios
- Sponsor & IRB Scenarios
- Site Leadership Scenarios
- Career-Risk Scenarios
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