ICH GCP R3 is now in English & EU languages. Book Now
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
  • Medical DevicesMedical DevicesRight Arrow
  • AI ClinicalAI ClinicalRight Arrow

About

The Clinical Trial Project Management Course by Whitehall Training provides a comprehensive foundation for professionals and combines standard project management methods with the specialized context of clinical research. Core content typically covers trial fundamentals (design, phases, GCP ethics/regulations), project planning and scheduling (scope definition, work breakdown structures, Gantt charts), budgeting/financial management, quality and risk management, vendor/CRO oversight, site management and patient recruitment, communication and leadership, and study close-out. These topics are drawn from international guidelines – notably ICH-GCP E6(R3) and related regulations – and from PM frameworks. Courses emphasize practical skills (e.g. building project plans, preparing budgets, conducting risk assessments) in line with regulatory standards.

Course Syllabus

  1. Overview of clinical trial phases, stakeholders, and regulatory landscape

  1. Covers study design elements (endpoints, randomization, blinding, statistical considerations) and the regulatory submission process (IND/CTA filing, ethics submissions)

  1. Teaches standard PM techniques as applied to trials: defining scope, milestones, and deliverables; creating Work Breakdown Structures and project schedules (Gantt charts, critical path analysis)

  1. Focuses on clinical trial costing, budget development, and financial monitoring

  1. Introduces quality management systems and risk-based approaches (per ICH E6(R3) and E8(R1))[15]

  1. Covers outsourcing strategy: selecting CROs and other service providers, creating quality agreements, and contract management

  1. Emphasizes interpersonal skills and team coordination

  1. Addresses operational execution: site selection/activation, patient recruitment strategies, retention tactics, and site oversight

  1. Focuses on ongoing control of the trial: using metrics, dashboards, and status reports

  1. Covers steps to end a trial and hand over for analysis: database lock, final monitoring, regulatory reports, archives

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...

Frequently Asked Questions

The Clinical Trial Project Management Course by Whitehall Training provides a comprehensive foundation for professionals and combines standard project management methods with the specialized context of clinical research.

  • The fundamentals of clinical research and trial phases and core responsibilities and day-to-day tasks of a CRA
  • Key ICH GCP E6(R3) principles and regulatory expectations
  • How to prepare for and conduct monitoring visits
  • Risk-based and remote monitoring approaches
  • Investigational Product (IP) oversight and accountability
  • Safety reporting requirements (AE/SAE/SUSAR)
  • Site communication, documentation, and issue escalation
  • Close-out procedures and essential record archiving

This course is ideal for individuals who want to begin or advance a career in clinical research, including:

  • Aspiring Clinical Research Associates (CRAs)
  • Clinical trial site staff transitioning into monitoring roles
  • Clinical Research Coordinators (CRCs) seeking career progression
  • Professionals working in pharmaceutical, biotech, or CRO environments
  • Anyone seeking a strong foundation in monitoring, GCP, and site oversight .
No prior CRA experience is required, but familiarity with clinical research or GCP is helpful.

  • Industry-aligned CPM training with global recognition
  • Fully updated to ICH GCP E6 (R3) requirements
  • Ideal for aspiring CPMs and those transitioning from site roles
  • Practical, scenario-based learning to build real-world confidence
  • Certificate issued upon successful completion