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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...
Phase II & III – Efficacy & Pivotal Trials Learning Path
4.1
★★★★★
92% Recommended
Updated 2025
24 hours
198 active users
24 points
If you'd like to swap a course or add additional courses, simply let us know — Reach out to us and we’ll customize a learning path tailored to your training needs.
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1 x Phase II & III – Efficacy & Pivotal Trials Learning Path
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Each course includes:
Fully compliant
This learning path is aligned with ICH GCP E6 (R3), EU Clinical Trials Regulation (EU CTR 536/2014), FDA clinical trial guidance, TMF Reference Model, and ICH E9 statistical principles — providing comprehensive compliance coverage for Phase II and III trial operations. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
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 a database, re-sitting the exam does not 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 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.
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About
The Phase II & III – Efficacy & Pivotal Trials Learning Path is designed to equip clinical research professionals with the comprehensive operational, regulatory, and data management knowledge required to deliver complex multi-site efficacy and pivotal clinical trials. Covering protocol development, study start-up, site selection and management, risk-based monitoring, trial master file excellence, clinical data management, and data privacy compliance, this programme provides an end-to-end operational framework for Phase II and III trial execution.
Participants will develop the skills to manage the full operational lifecycle of efficacy and pivotal studies — from protocol design and site activation through to monitoring, data management, and regulatory compliance — with a strong focus on the multi-stakeholder, multi-site environments that characterise Phase II and III programmes.
How this differs from the Phase I Learning Path
The Phase II & III Learning Path addresses the scale and complexity of multi-site, multi-country efficacy and pivotal trials. It focuses on operational delivery — protocol management, site networks, remote monitoring, TMF governance, and data management — and is designed for professionals managing or supporting large-scale clinical programmes.
In comparison, the Phase I – First-in-Human Learning Path focuses on the early-phase environment, the unique safety considerations of dose escalation studies, and the site-level operations of Phase I units. This pivotal trials learning path is the natural progression for professionals who have established foundational GCP and early-phase knowledge and are moving into the operational leadership of confirmatory clinical programmes.
Who Should Enrol?
- Clinical Research Associates (CRAs), senior CRAs, and clinical operations professionals managing Phase II and III studies.
- Clinical Operations Managers, Trial Managers, and sponsor/CRO personnel responsible for multi-site trial delivery.
- Study start-up, feasibility, TMF, and clinical data management professionals seeking operational advancement.
- Regulatory affairs professionals, clinical study coordinators, and professionals transitioning from Phase I into large-scale efficacy and pivotal trials.
What you will learn
Understand the design and execution of Phase II and III clinical trials, including efficacy studies, pivotal trials, and their role in drug development.
Learn how to develop clinical trial protocols, manage study start-up activities, and coordinate multi-site trial operations effectively.
Develop knowledge of risk-based monitoring, Trial Master File (TMF) compliance, and clinical data management aligned with CDISC standards.
Gain practical understanding of regulatory expectations, including ICH-GCP (R3), data privacy requirements (GDPR/HIPAA), and oversight of large-scale clinical trials.
Courses Included
Designing robust clinical trial protocols — objectives, endpoints, eligibility criteria, statistical considerations, and ICH E6 alignment
2 hours
3 pointsTranslating protocol design into operational execution — amendments, deviation management, and cross-functional protocol governance
2 hours3 points
Site activation processes — feasibility, contract and budget negotiation, IRB/IEC submissions, and site initiation visit preparation
3 hours2 points
Regulatory obligations for trial registration in ClinicalTrials.gov, EudraCT, and ISRCTN — timelines, data fields, and results reporting requirements
2 hours3 pointsSite feasibility assessment, selection criteria, site performance monitoring, and remediation strategies for multi-site Phase II and III programmes
2 hours3 pointsRisk-based monitoring frameworks, remote SDV strategies, centralised statistical monitoring, and regulatory expectations under ICH GCP (R3)
3 hours2 pointsCRA competencies in oncology trials — tumour response criteria, oncology-specific safety monitoring, and therapeutic area operational considerations
2 hours3 pointsTMF structure, content requirements, quality metrics, and compliance with the TMF Reference Model and EU CTR expectations
2 hours3 points
Data collection, validation, query management, database lock, and CDISC standards in Phase II and III clinical data management
2 hours3 pointsOur Certified Customers
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Frequently Asked Questions
- Clinical Research Associates (CRAs) and senior CRAs managing Phase II and III sites
- Clinical Operations Managers and Trial Managers in sponsor and CRO organisations
- Study Start-up and Feasibility Specialists
- Trial Master File and Clinical Data Management professionals
- Regulatory Affairs professionals involved in trial oversight and submissions
- Clinical Study Coordinators at Level II and III seeking operational advancement
- Sponsor and CRO professionals responsible for multi-site trial delivery
- Professionals seeking to transition from Phase I into large-scale efficacy and pivotal trials
Upon completion of this learning path, participants will be able to develop and manage clinical trial protocols, lead study start-up and site management activities, apply risk-based monitoring frameworks, maintain TMF compliance, manage clinical data in line with CDISC standards, and ensure data privacy compliance under GDPR and HIPAA — equipping them to oversee the operational delivery of Phase II and III clinical trials in line with ICH GCP (R3) and current regulatory expectations.
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