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GCP Changes 101

Clinical-Research-101-(May-2018)

Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The ninth installment in our Clinical Research 101 series is by Erin Cherban, Chief Clinical Research Officer at CHÉOS. The following is an overview of the recent changes to GCP guidelines. A video presentation of this information is available here.

In the past, Ms. Cherban worked for CHÉOS and the CTN for over ten years and in the interim, served as Director of Clinical Research Operations at the Rick Hansen Institute. Her clinical support expertise includes clinical trial concept and protocol development; international, multi-centre clinical trial project management; monitoring/auditing clinical trial sites; and collaborative leadership of multidisciplinary teams.

Do you know that Health Canada is adopting an update to Good Clinical Practice?

In 2017, Health Canada (the Canadian regulator of clinical trials) informed the Canadian research community that they planned to adopt the International Council for Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)on April 1, 2018. However, on May 11, 2018, they subsequently informed us of the following:

  • As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of ICH guidance. By way of this Notice, Health Canada is advising of its intent to implement the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). The target date for full implementation of ICH E6(R2) has been extended to April 1, 2019 to allow sufficient time for the training of regulators and stakeholders, which will also include training of ICH E17: Multi Regional Clinical Trials.

How is GCP (R2) different than the previous version?

According to Health Canada:

Description of the Integrated Addendum

The Integrated Addendum ICH E6(R2) provides a unified standard on GCP.

Since the finalisation of the ICH GCP Guideline in 1996, the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. With this addendum, the guideline has been amended to:

  • Encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
  • Update standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency.

In this addendum, changes were integrated directly into several sections of the parental guideline.

What has been added?

The addenda are found in the following sections:

  • Introduction
  • Glossary: 1.63, 1.64, 1.65
  • Principles of ICH: 2.10, 2.13
  • Investigator Resources: 4.2.5, 4.2.6 and Records and Reports: 4.9.0
  • Essential documents: Introduction
  • Sponsor — Quality Management: 5.0, 5.0.1, 5.0.2, 5.0.3, 5.0.4, 5.0.5, 5.0.6, 5.0.7
    • Contract Research Organization: 5.2.2
    • Trial management, data handling, record keeping: 5.5.3
    • Monitoring: 5.18.3, 5.18.6, 5.18.7
    • Non-Compliance: 5.20.1

Or in summary:

  • An expanded introduction
  • Three new definitions added — for example, now defines “Certified Copy”
  • Investigator duties reinforced, expectation of ALCOA-C (attributable, legible, contemporaneous, original, accurate — complete), demonstration of oversight and training
  • Sponsor responsibilities added, including risk-based management systems
  • New addition to Essential Documents

An online or downloadable PDF version can be found here.

So how does Health Canada interpret GCP (R2) when conducting inspections?

Health Canada produced a new guidance document entitled: Guidance Document Part C, Division 5 of the Food and Drug Regulations“Drugs for Clinical Trials Involving Human Subjects” that was circulated for comment until April 15, 2018. The purpose for the document is:

  • Health Canada has recognized a need to provide guidance in the interpretation of the Regulations, and specifically in terms of its relationship to ICH E6.  This document is intended to fulfill this need, as well as to provide additional guidance where is necessary or when ICH E6 does not apply.

The clinical research community appreciates Health Canada’s desire to provide guidance around their interpretation as this level of guidance was not previously available.

When will the final version of the Guidance document be available?

Now that the implementation date has been pushed back to April 2019 and include training for of ICH E17: Multi Regional Clinical Trials, there has not been an announcement of the final version.  Once the final version is released, a copy will be added to the CHÉOS website here.

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