Buy the GCP R3 course & get a FREE eBook— your complete ICH-GCP R3 reference guide. Book Now →

  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations Learning Path - courses at £199
  • 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

Remote and Centralized Monitoring covers the strategy, tooling and operational discipline of modern monitoring under ICH GCP E6(R3). The course explores risk-based monitoring (RBM), centralised statistical monitoring, key risk indicators (KRIs), remote source data review, and the regulatory and privacy constraints that shape what 'remote' actually means at site. Learners apply the framework in worked examples ranging from KRI threshold breach response to designing a hybrid monitoring plan across multiple regulatory regions.

Who Should Enrol?

  • Clinical Research Associates (CRAs) and clinical monitoring professionals seeking to transition into remote or centralized monitoring roles.
  • Clinical Trial Coordinators, site staff, and clinical operations professionals involved in trial oversight and data review.
  • Professionals interested in Risk-Based Monitoring (RBM), RBQM, and modern clinical trial monitoring approaches.
  • Healthcare, life sciences graduates, and clinical research professionals looking to build careers in advanced monitoring practices.

What you will learn

Understand the fundamentals of clinical trial monitoring, including traditional, remote, centralized, and hybrid monitoring approaches.

Learn regulatory guidelines, Risk-Based Monitoring (RBM), Risk-Based Quality Management (RBQM), and the use of KRIs and dashboards in modern clinical trials.

Develop practical knowledge of remote monitoring workflows, including data review, site communication, documentation, and centralized statistical monitoring.

Gain insight into the daily responsibilities of a remote monitor and the key skills required for effective, risk-targeted, and data-driven clinical trial oversight.

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
87.0%
5.0%
3.0%
3.0%
2.0%
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...