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
  • MDRMDRRight Arrow
  • AI ClinicalAI ClinicalRight Arrow
Clinical Practice
Pharmacovigilance
Manufacturing
Laboratory Practice
Distribution
MDR
AI Clinical

About

The Clinical Research Associate (CRA) Course by Whitehall Training provides a comprehensive foundation for professionals responsible for monitoring clinical trials and ensuring they meet global regulatory, ethical, and quality standards. Designed for individuals seeking to build or advance a career as a CRA, this course delivers practical, industry-aligned training on site oversight, documentation, GCP compliance, and risk-based monitoring principles.

Aligned with ICH GCP E6 (R3) and international regulatory expectations, the course incorporates modern practices such as decentralized trials, remote monitoring, digital data systems, and risk-based oversight models widely used by leading sponsors and CROs.

PLEASE NOTE: while the curriculum aligns fully with TransCelerate BioPharma Inc. training standards, Whitehall Training cannot independently verify compliance if your previous GCP certification was obtained through another provider.

Course Syllabus

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

  1. Responsibilities, core competencies, and professional expectations

  1. Ethical principles, participant protection, and updated GCP framework

  1. Feasibility assessments, site qualification visits, and essential documents

  1. Purpose of monitoring, communication pathways, and monitoring plans

  1. Ensuring data accuracy, completeness, and ALCOA+ principles

  1. Centralized vs. on-site monitoring, risk indicators, and QTLs

  1. Accountability, storage requirements, and handling procedures

  1. Identification, documentation, escalation, and regulatory timelines

  1. Identifying non-compliance, CAPA processes, and communication strategies

  1. Digital systems, remote SDV, virtual visits, and data protection

  1. Verification of completeness, transfer of responsibilities, and record retention

  1. Skills development, certification pathways, and industry expectations

Our GCP 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

CRA roles are central to the success of clinical trials, requiring strong analytical skills, meticulous attention to detail, and a deep understanding of Good Clinical Practice (GCP). This course equips learners with the knowledge and confidence needed to perform effective site monitoring, assess data quality, oversee investigator activities, and maintain participant safety across all phases 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 CRA training with global recognition
  • Fully updated to ICH GCP E6 (R3) requirements
  • Ideal for aspiring CRAs and those transitioning from site roles
  • Practical, scenario-based learning to build real-world confidence
  • Certificate issued upon successful completion