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ICH Good Clinical Practice (GCP) Refresher (Including E6 R3)

GOOD CLINICAL PRACTICE E6(R3) REFRESHER TRAINING COURSE INFORMATION

GCP Refresher Course
£99
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Refresh your knowledge of Good Clinical Practice and remain up to date with the latest ICH GCP E6(R3) principles and requirements.

Created by experienced clinical research and compliance professionals, this accredited online GCP refresher course reinforces essential GCP knowledge while explaining how E6(R3) applies to the ethical design, conduct, management and oversight of clinical trials.

The course is intended for clinical research professionals who have completed comprehensive GCP training within the previous two years and now require refresher training.

Current Status

Not Enrolled

Price

£99.00

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KEY FEATURES OF OUR ONLINE GCP REFRESHER TRAINING COURSE:

  • Comprehensive refresher training incorporating ICH GCP E6(R3)
  • 100% online and available on demand
  • Learn anywhere, at your own pace
  • Developed by GCP experts with more than 35 years of clinical research experience
  • Interactive content, practical examples and robust knowledge checks
  • Accredited by the Faculty of Pharmaceutical Medicine for CPD
  • Four CPD points available
  • Certificate awarded upon successful completion
  • Suitable for TransCelerate-aligned training programmes
  • Available for individual learners and corporate teams
  • Course content available in 32 languages

The Faculty of Pharmaceutical Medicine has approved this online GCP Refresher training course for CPD points.

CPD POINTS AVAILABLE: 4

Course Content

Module 1
Module 2
Module 3 – Summary & Exam

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PRACTICAL GCP REFRESHER TRAINING INCORPORATING ICH E6(R3)

Good Clinical Practice provides the internationally recognised ethical, scientific and quality framework for clinical trials involving human participants.

Regular GCP refresher training helps clinical research professionals maintain their knowledge, recognise changes in regulatory expectations and continue performing their responsibilities in accordance with current standards.

Our online GCP refresher course reinforces the essential principles of Good Clinical Practice while incorporating the latest ICH GCP E6(R3) requirements.

The course revisits important areas including participant rights, safety and wellbeing, informed consent, investigator and sponsor responsibilities, protocol compliance, quality management, safety reporting, monitoring, data governance and essential records.

It also examines the increased emphasis within E6(R3) on quality by design, critical-to-quality factors, proportionate risk management, reliable data, service-provider oversight and the appropriate use of technology in modern clinical trials.

Interactive content, realistic scenarios and robust knowledge checks help learners revisit familiar concepts, identify gaps in their knowledge and apply current GCP expectations to their everyday clinical research responsibilities.

Important: This refresher course is designed for professionals who have completed a comprehensive GCP course within the previous two years. Learners without suitable previous GCP training should complete our full ICH GCP E6(R3) training course instead.

WHO SHOULD COMPLETE GCP REFRESHER TRAINING?

This course is designed for clinical research professionals who already have a foundation in Good Clinical Practice and need to renew or refresh their knowledge, including:

  • Clinical Research Associates and monitors
  • Clinical Trial Managers
  • Clinical Research Coordinators
  • Principal investigators and sub-investigators
  • Study-site personnel
  • Clinical trial sponsors
  • CRO employees and consultants
  • Clinical operations professionals
  • Regulatory affairs professionals
  • Quality assurance and compliance teams
  • Clinical data management professionals
  • Pharmacovigilance and safety personnel
  • Medical and scientific affairs teams

The course is particularly suitable for professionals whose role requires periodic GCP refresher training and who need to demonstrate that their knowledge remains current.

GCP REFRESHER TRAINING FOR INDIVIDUALS AND CLINICAL RESEARCH TEAMS

Whether you need to renew your own GCP training or manage refresher training across a clinical research organisation, Integrity Clinical Compliance provides a flexible online learning solution.

INDIVIDUAL LEARNERS

Purchase immediate online access and complete your GCP refresher training at a time and pace that suits you.

The course allows experienced clinical research professionals to revisit essential GCP requirements, update their knowledge of ICH E6(R3) and obtain evidence of successful completion.

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CORPORATE AND TEAM TRAINING

Need to provide consistent GCP refresher training to employees, contractors or clinical trial site personnel?

We provide corporate course licences for sponsors, CROs, pharmaceutical and biotechnology companies, research organisations and clinical trial sites.

Multiple licences can help your organisation manage periodic GCP training while maintaining consistent course content, completion records and oversight across different departments and locations.

Course content can be made available in 32 languages, supporting clinical research teams, contractors and sites operating across multiple countries.

Depending on your requirements, we can also provide bespoke training tailored to your organisation’s procedures, clinical trial models, employee roles and compliance priorities.

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WHAT WILL I LEARN FROM THIS GCP REFRESHER TRAINING COURSE?

Understand the key principles and updates introduced in ICH GCP E6(R3) and their impact on clinical trial conduct.

Apply updated GCP requirements and responsibilities to support compliant, ethical and effective trial conduct.

Apply risk-based approaches to quality management, oversight and monitoring throughout the clinical trial lifecycle.

Apply GCP requirements for participant safety, informed consent, data integrity and data governance to maintain high-quality clinical trial data.

FREQUENTLY ASKED QUESTIONS ABOUT GCP REFRESHER TRAINING

WHO IS THIS GCP REFRESHER COURSE FOR?

This course is designed for clinical research professionals who have already completed comprehensive Good Clinical Practice training and need to refresh and update their knowledge.

Learners should normally have completed a full GCP course within the previous two years. The refresher is suitable for investigators, Clinical Research Associates, study coordinators, Clinical Trial Managers, sponsor and CRO personnel, quality teams and other professionals involved in clinical trials.

WHAT IS THE DIFFERENCE BETWEEN THIS REFRESHER COURSE AND THE FULL ICH GCP E6(R3) COURSE?

The GCP refresher course assumes that learners already understand the foundations of Good Clinical Practice. It revisits essential requirements, reinforces existing knowledge and incorporates the latest ICH GCP E6(R3) expectations.

The full ICH GCP E6(R3) course provides more comprehensive training and is intended for people who are new to clinical research, have not previously completed full GCP training or require a complete GCP course rather than periodic refresher training.

WHAT IS THE DIFFERENCE BETWEEN THIS REFRESHER AND THE R2-TO-R3 UPDATE COURSE?

This refresher provides broader revision of essential Good Clinical Practice requirements alongside the latest E6(R3) content. It is intended for experienced professionals who need to refresh their overall GCP knowledge.

The R2-to-R3 update course focuses specifically on the differences between ICH GCP E6(R2) and E6(R3). It is more suitable for learners whose existing GCP knowledge is current but who require focused training on what has changed.

SHOULD I TAKE THE REFRESHER COURSE OR THE FULL GCP COURSE?

Choose this refresher course if you have previously completed comprehensive GCP training, normally within the past two years, and need to renew or reinforce your knowledge.

Choose the full course if:

  • You are new to clinical research
  • You have not previously completed comprehensive GCP training
  • It has been a significant length of time since your previous training
  • Your employer or sponsor requires a full GCP course
  • You need a complete introduction to ICH GCP E6(R3)

You should confirm any specific training requirements with your employer, sponsor or institution before purchasing.

DOES THE GCP REFRESHER COURSE INCLUDE ICH GCP E6(R3)?

Yes. The course incorporates ICH GCP E6(R3) and covers current expectations relating to participant protection, quality by design, critical-to-quality factors, proportionate risk management, roles and responsibilities, data governance, monitoring, essential records and technology.

This allows learners to refresh their existing GCP knowledge while becoming familiar with the principles and requirements of E6(R3).

WILL I RECEIVE A GCP REFRESHER CERTIFICATE?

Yes. Learners receive a certificate after successfully completing the course and its assessment. This provides evidence of completed GCP refresher training incorporating ICH GCP E6(R3).

The Faculty of Pharmaceutical Medicine has approved the course for four CPD points.

IS THIS GCP REFRESHER COURSE TRANSCELERATE-ALIGNED?

The course is suitable for TransCelerate-aligned GCP training programmes.

However, where a learner’s original comprehensive GCP training was completed with another provider, Integrity Clinical Compliance cannot verify whether that previous training satisfied all applicable requirements. Learners and organisations should review their original training records and confirm any sponsor-specific requirements.

CAN ORGANISATIONS PURCHASE MULTIPLE GCP REFRESHER COURSE LICENCES?

Yes. Corporate licences are available for organisations that need to provide periodic GCP refresher training to employees, contractors or clinical trial site personnel.

Corporate options can include multiple learner licences, centralised administration, progress tracking, completion records and course content in up to 32 languages.

If this course isn’t right for you, take a look at our other online clinical courses.