By Jean Smart, RAC

There are several newsworthy Clinical Trial initiatives in the spotlight for note in this quarter.


Health Canada Guidance 0100

The long awaited Health Canada GUIDE 0100 (GUIDE 0100) was released on August 20, 2019.   It is Health Canada’s interpretation of the regulations pertaining to: ICH E6R2 Good Clinical Practice and the Food and Drug Regulations Part C Division 5. Health Canada GUIDE 0068 ‘Records for Clinical Trials’ is still in effect and acts as an accompaniment to GUIDE 0100.   It is recommended that you read GUIDE 0100 and note it in your training records as ‘Read and Understood’.  Of particular note, GUIDE 0100 was published by the Regulatory Operations Enforcement Branch (ROEB) formerly known as the Health Canada Inspectorate. Clinical Trials BC is has been featuring this topic in our travelling ASQ US sessions throughout the province.  The next session is in Kelowna, BC on November 6, 2019.  Call to book a session at your program or institution.

Health Canada, Regulatory Operations and Enforcement Branch (ROEB), Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) – Summary. August 20, 2019


E8(R1) Global Stakeholders Meeting

As part of the GCP Renovation Plan, an ICH E8(R1) stakeholder meeting targeted at global stakeholders will be held on October 31, 2019 in Silver Spring, Maryland, USA. Regulatory Authority and general consultation has already been held.  This meeting will build towards general Consensus (ICH Step 3) discussions for the next ICH Assembly meeting.


The ICH Assembly

The next International Council for Harmonization (ICH) Assembly will be held in Singapore in the third week of November 2019.  Two of the many highlights of this session as related to Clinical Trials will be:

E6(R3) Good Clinical Practice (GCP) has been endorsed by the ICH Assembly in June 2019. The ‘3’ is not a typographical error. The newly appointed E6R3 Working Group (informal) will be meeting to discuss a Work Plan and Concept Paper for further GCP changes as part of the GCP Renovation Plan. E6R2 was fully implemented in Canada on April 3, 2019.

E8(R1) General Considerations in Clinical Trials

The Modernisation of ICH E8 is the first step towards the GCP Renovation initiated in 2017. The draft E8(R1) has been out since May 8, 2019.

The working group (WG) will meet to discuss feedback and consider consensus on whether the modernisation of this foundational document addresses the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. ‘The draft was to: (1) identify 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 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.’(GCP Renovation Plan).

This will be the first of significant changes to Clinical Trials governance in over twenty years. 


Regulatory Enrolment Process (REP) Pilot

Health Canada will be launching the new pilot REP Pilot Project on November 1, 2019.  It is intended to help sponsors file electronic submissions of: CTA applications (CTA), CTA Amendments (CTA-A), Clinical Trial Notifications (CTA-N) and Pre-Clinical Trial Application Consult meetings (PRE-CTA).

The first round will be for industry sponsors and there are future plans for an expansion to include: research institutes, hospitals and institutions.