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  • Preclinical & Laboratory Foundations
  • Phase I – First-in-Human Trials
  • Phase II & III – Efficacy & Pivotal Trials
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations - courses at £229
  • Good Laboratory Practice (GLP)
  • 21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories
  • OSHA Laboratory Safety Training
  • Laboratory Management Systems ISO/IEC 17025:2017
  • Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11)
  • Qualification Validation Training
  • Cleaning Validation
  • ISO 9001:2015 - Quality Management System for Pharmaceuticals

About

This course is recommended for CRAs, lead CRAs, monitoring leads, central monitors, project managers and quality professionals overseeing trial monitoring. On completion, learners will be able to design a risk-based monitoring plan, define and react to KRIs, lead remote source review under privacy constraints, and articulate the limits of remote monitoring under different regulatory regimes. Aligned with ICH GCP E6(R3), TransCelerate RBM framework, and FDA, EMA and MHRA monitoring guidance.

Course Syllabus

  1. What clinical trial monitoring is
  2. The evolution of monitoring
  3. Traditional on-site monitoring
  4. Remote monitoring
  5. Centralized monitoring
  6. Risk-Based Monitoring & RBQM
  7. Regulatory guidelines
  8. KRIs and dashboards
  9. Hybrid monitoring
  10. Modern monitoring is risk-targeted and data-driven

  1. A day in the life
  2. The tools
  3. Data review
  4. Centralized statistical monitoring
  5. Communication with sites
  6. Documentation
  7. Team interactions
  8. Key skills
  9. Remote monitoring is rhythm
  10. Course complete

Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

4.7
Average Rating
536 global ratings
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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

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...