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 and suggestions for future editions.

Please contact us with any questions or concerns regarding research and clinical trials. You can reach us at [email protected]. We are here to support you!

We are introducing a pre- and post-audit question for research teams as we conduct our audit to gauge the level of apprehension teams feel when selected for an audit and when the audit is complete.

A participant survey may also be included in the audit process to learn more about the participant’s research experience and to ensure their rights are being respected. The participant survey can also be done as a process audit (separate from a routine audit).

Summary of HC Inspection:

A research team underwent a Health Canada Inspection in May 2023. This was the first audit since 2019 due to the COVID pandemic and not being selected for virtual inspections.

The NSH site was determined to be compliant (congratulations!) with the standards of ICH-GCP E6 and Health Canada part C- Division 5.

There were valuable learnings from the Inspection, and the group created a CAPA (corrective action and preventative actions) report to address findings. There were numerous institutional-level findings that have or will be incorporated into policy and procedure through the HRPP and will benefit all researchers and ensure research participants' rights, safety, and well-being are being protected.

You can access the Health Canada Drug and Health Products Inspection Database to view clinical trial inspections conducted in Canada and the rating given. If you click on the rating at Inspection, we can see the report summary for the study.                            

TCPS:

The Tri-Council Policy Statement is the basis for all REB guidelines and standards and was updated in 2018.

This means PIs, Sub-Is, and all research team members must be certified or have re-certified on the new TCPS2 CORE tutorial as of June 1, 2023. The new certificate of training will read TCPS2: CORE 2022.                       

The Research Education Program has been supporting CANTRAIN – A national clinical trials training initiative which began last summer as a collaboration between NSH, McGill, Sickids and various other clinical trial hot spots across the country. CANTRAIN is the result of a national consultation across Canada in response to the CIHR – Clinical Trials Training Platforms call in the summer of 2022, a necessity in response to shortcomings we experienced facing COVID, and an integral component of “Canada’s Biomanufacturing and Life Sciences Strategy”. For more information click HERE

By the Fall, we will welcome 3 new positions based at NSH to support the CANTRAIN training and mentorship program; a National Program Designer and Developer, A Provincial Coordinator and a Clinical Research Educator. 

HRPP SOP Roll-Out

You can find the new participant recruitment SOP here.

Patient Safety Alerts and SIMS Reporting

The following was originally communicated by Nova Scotia Health Quality Improvement and Safety

• Patient Safety Alert Disclosure
• Medical Device/Product Incident Reporting in SIMS

The word placebo isn't medical jargon derived from a pharmaceutical company. In fact, it is an old Latin term that means "I shall please," and it refers to flattering someone.

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