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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 – Oncology Practitioner
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 Research Associate – Oncology Practitioner
| 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), RECIST 1.1, iRECIST, FDA oncology center guidance and EMA oncology working party output, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by senior oncology CRAs and clinical scientists to ensure that learners can monitor oncology trials with confidence.
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About
This course is recommended for clinical research associates, lead CRAs and monitoring leads working on oncology trials, and for project managers overseeing oncology programs. On completion, learners will be able to monitor oncology trials with confidence - reviewing eligibility, dose, response and safety - and lead site-level resolution of the deviations most common to oncology research. Aligned with ICH GCP E6(R3) and current FDA, EMA and MHRA oncology guidance.
Course Syllabus
- Who is an Oncology CRA?
- Why oncology is different
- End-to-end CRA workflow
- The Oncology CRA's stakeholder map
- Career pathway
- What is cancer?
- The Hallmarks of Cancer
- The genetics of cancer
- Major cancer types
- How cancer spreads
- Tumour microenvironment
- Histological classification
- Molecular classification
- TNM staging
- Other staging systems
- Grading systems
- Performance status
- Reading the pathology report
- Surgery & locoregional therapy
- Chemotherapy
- Targeted therapy
- Immunotherapy
- Cellular therapy
- Hormone therapy
- Combination regimens & treatment intent
- Phase 1 oncology trials
- Phase 2 oncology trials
- Phase 3 oncology trials
- Statistical design elements
- Special populations & Phase 4
- Survival endpoints
- Response endpoints
- RECIST 1.1 — the universal solid-tumour response criteria
- iRECIST and irRECIST
- Lugano, IMWG, RANO
- Surrogate endpoints, PROs, QoL
- Adverse event terminology
- CTCAE v5.0 — the grading language
- Haematologic toxicities
- Non-haematologic toxicities
- Immune-related adverse events (irAEs)
- AE/SAE reporting workflow
- Why dose modifications matter
- Hold criteria and recovery thresholds
- Dose reductions
- Permanent discontinuation
- Toxicity-specific dose modifications
- Treatment delays and missed doses
- The monitoring visit lifecycle
- Pre-visit preparation
- On-visit execution
- Monitoring reports & follow-up
- Site relationship management
- Hybrid monitoring
- Data integrity foundations — ALCOA+
- EDC and query management
- SDV depth and prioritisation
- Imaging data review
- Lab data review
- Drug accountability data
- ICH GCP E6(R3)
- FDA framework
- EMA / EU framework
- MHRA, PMDA, NMPA
- Informed consent
- Essential documents
- Why risk-based monitoring
- Risk identification
- Key Risk Indicators (KRIs)
- Quality Tolerance Limits (QTLs)
- Adaptive monitoring
- Audit and inspection types
- FDA BIMO inspections
- International inspections
- Preparing the site
- During the inspection
- Responding to findings
- Complex eligibility scenarios
- Safety crisis scenarios
- IP and pharmacy crisis scenarios
- Site relationship crises
- Decision frameworks
- Capstone scenarios
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