ICH E8(R1) Guideline Reaches Approval

6 October 2021

Clinical Trials BC is delighted to share that The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has approved the revised version of the primary efficacy document known as ‘General Considerations in Clinical Trials’.

The ICH is an organization that brings together the regulatory authorities and pharmaceutical industry to develop scientific and technical ICH guidelines and policy. These are incorporated and adopted into the Canadian Regulations and guidelines associated with clinical trial and regulatory approvals across product lines.

‘This modernization of ICH is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The E8R1 revision incorporated the most current concepts achieving fit for purpose data quality as one of the essential considerations for all clinical trials” (ICH)’.

‘E8R1 General Considerations in Clinical Trials’ is referred to as the foundational document for Clinical Trials globally. It identifies a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to (1) protect human subjects; (2) address a broader range of trial designs and data sources; (3) provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies. This has significant educational and orientation implications for Clinical trial research teams in BC who should have documented training on the new elements.

Clinical Trials BC is poised and ready to bring research teams in BC up to date with education on E8(R1) topics including:

Critical to Quality Factors, Quality by Design, General Considerations in Clinical Trials update and overview, Quality Management Systems, quality-related Risk Management, and Patient Participation & Engagement in Clinical Trials.

Clinical Trials BC is offering educational sessions for the above topics. Check out our offered dates and times with the link below. We also offer trainings for institutions, contact us for institutional bookings.

Jean Smart, Regulatory and Quality Officer, Clinical Trials BC

Alison Orth, Director, Clinical Trials BC

E8(R1) Educational Sessions Dates and Times:

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Contact us:

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Official Announcement from ICH: 

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