Dear Nova Scotia Health clinical trials community,

Thank you for tuning into the CT Newsletter. We hope you find our newsletter both helpful and informative. We welcome your comments, suggestions and content for future editions.

Please contact us with any questions or concerns regarding research and clinical trials. You can reach us at ResearchQuality@nshealth.ca. We are here to support you!

Please notify ResearchQuality@nshealth.ca if you are:

• Contacted by your Sponsor to undergo an audit.
• Contacted by Health Canada to undergo an inspection, non-compliance issues, etc.

Division 5 of the Food and Drug Act is under review to bring forward a modernized clinical trial framework. The COVID pandemic introduced some of the changes such as verbal and remote consent.

Other proposed changes include:

• Single authorization of a trial
• Enable decentralized trials
• Proportional risk-based approach
• Registration & public disclosure of results

The modernized regulatory requirements are expected to be in place in mid to late 2026

The ICH E6 is currently undergoing its third revision (R3). This update aims to include a risk-proportionate approach to designing and conducting clinical trials. ICH has approached this revision through rigorous Stakeholder engagement, dating back to April 2020, with the goal of ensuring that updated guidelines meet the needs of all types of clinical trials. The R3 Draft was released in May 2023 and is available here.

ICH-GCP E6(R3) is expected to be released in 2025.

HRPP-SOP-002 (Administrative Management of Procedures and Policies in HRPP) has been issued! All issued SOPs may be found here. Stay tuned for more SOPs to be added in the coming months.

In case you missed it, an update on the progress and future state of the HRPP can be found in the following slide deck: HRPP for Research Group_February 2024.pdf

CANTRAIN is pleased to invite you to visit its website portal, NOW OPEN, for Registration for Clinical Trials Training Courses:  https://wecantrain.ca/registration-cttp/

Did you know that as per Food and Drug Regulations: Part C, Division 5, Clinical Trials in Canada are prohibited by default?

This is why a Clinical Trial Application (CTA) is required to be submitted to Health Canada for Phase I-III clinical trials. If approved, a No Objection Letter (NOL) will be issued, and the trial may proceed.

Thank you for reading the CT Newsletter! Our next edition will be published in June 2024.

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