GCP Training 2017-07-06T13:49:02+00:00
“Interactive elements kept the group engaged such that what is usually quite a dry subject didn’t feel boring.”

“Got me thinking about some things I need to check on in my Group.”

“I can say your session was very well received by all.”

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ICH E6 Good Clinical Practice (GCP) Training

Quality assured training that gets results!

This course can be tailored to your specific requirements.

DELIVERY FORMAT : This training can be provided via live, interactive webinars or one day, face-to-face skills development workshop.  To book onto one of our public webinars please visit our Webinars & Events page.

A wide range of GCP training can be provided ranging from Introduction to GCP, GCP “refresher” training for experienced people and executive overview programs.

TransCelerate Approved GCP Training

Our ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Additional Quality Assurance

With so many GCP training providers to choose from, it can be difficult to decide which one is right for your organization.  In addition to be delivered by Qualified Clinical Research Trainers, our GCP training meets the following quality assurance standards:

  • It is mapped to the International Standard Classification of Education Framework produced by UNESCO (The United Nations Educational, Scientific and Cultural Organization), a specialized agency of the United Nations.
  • All 9  of the 9 IMI Education and Training Quality Standards.

Who is this course for?

GCP training is vital for all staff working in the clinical research industry.  IAOCR GCP training can be tailored to the requirements of your audience.

Course Content (Introduction to GCP)

  • Introduction to Purpose & Principles of GCP
  • Historical aspects and the evolution of GCP
  • The Declaration of Helsinki
  • The principles of GCP according to the International Conference on
  • Harmonisation
  • Roles & Responsibilities in Clinical Research
  • Sponsors
  • Investigators
  • Ethics Committees
  • Overview of Current Regulations & Their Application
  • General review of the EU and US legislation
  • Upholding the Purposes of GCP – Practical Aspects
  • Informed consent
  • Safety reporting
  • Data Management
  • Maintaining essential documents

Course Objectives

By the end of the course the participants will be able to:

  • Describe the two purposes of GCP
  • Relate GCP principles to relevant aspects of their job role
  • Summarise the roles and responsibilities of Sponsors, Investigators and Ethics
  • Committees in the context of Clinical Research
  • Outline the purpose and scope of the relevant EU Directives and Regulation
  • Describe some practical techniques in upholding the purpose and principles of GCP

Learning Credits / Contact Hours / Continuing Education Points

The one day Introduction to GCP Training Course is an accredited program equal to 10 notional learning hours and equivalent to 10 CPD / CME / CEP / CPE / contact hours.

1/2 day “Refresher” training programs are equivalent to 5 CPD / CME / CEP / CPE / contact hours.

Live, interactive webinar sessions can also be provided.

Optional Certification

IAOCR provides the additional option of independent accreditation (certification) of individuals.  This process involves individuals submitting evidence that they can apply their knowledge of GCP in a practical workplace setting. This independent verification of competence provides reassurance to clinical trials sponsors and patients that the people working on their trials are fit for purpose.  For more information about individual accreditation visit our Qualified Status Certification page.

Corporate Roll-Out

We are experienced at providing large scale solutions, including “train the trainer” programs. Please contact us to discuss your requirements and how we can work in partnership with you.

Discounts Available

We believe that best practice in clinical research should be available to everyone. Contact us to discuss discounted rates for not-for-profit organizations, micro businesses and SMEs in developing regions.

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