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!

Are you involved in an Investigator-Initiated clinical trial? 

• Registration of your study in a publicly accessible registry, such as clinicaltrials.gov, is a requirement of the Research Ethics Board and must be completed before full approval of the study will be granted.  

• As per Article 11.11 of TCPS2:2022, researchers are also responsible for updating the registry in a timely manner for: 

1. New information (e.g., change in study status) 
2. Safety and, where feasible, efficacy reports 
3. Reasons for stopping a trial early; and 
4. Location of findings 

Chapter 11 Section D of TCPS2:2022 provides the explanations the reasons for registration of clinical trials for the protection of human participants. 

“Tri-Council Policy Statement (TCPS) is a joint policy of Canada’s three federal research agencies – the Canadian Institute of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), or ‘the Agencies’. As a condition of funding by these Agencies, researchers are expected to adhere to the TCPS.” 

The Nova Scotia Health Research Ethics Board requires all Nova Scotia Health researchers and research team members have certification in TCPS as evidence of training for the ethical conduct of research involving humans, regardless of the type of research or funding source. 

TCPS2-CORE:2022 training  

Good Clinical Practice (GCP) is a set of rules and guidelines designed to ensure the safety of participants in clinical trials and the integrity of data collected during clinical trials. It's also designed to protect the quality and reliability of data generated by clinical trials. Clinical trials that are regulated by Health Canada require compliance with GCP, including Phase IV studies. Canada follows GCP as described by the International Conference on Harmonization (ICH-GCP). 

Currently, we comply with ICH-GCP E6(R2), however, ICH-GCP E6(R3) is available as a draft document. There is no implementation date at this time, and the Education Office will keep us posted on changes for the future.  

As a reminder, ICH-GCP training is required every three years for applicable study team members who are involved in Health Canada clinical trials (including Phase IV trials).

• Sub-Investigators signing consent forms: for all those who missed the memo, please be informed that the REB is now allowing Sub-Investigators listed in ROMEO to sign consent forms on behalf of the Principal Investigator. Please see the following memo for more information.

• Updated wording on Letter of Support for Principal and Supervising Investigators: Please use the updated versions on ROMEO. The language under the “Qualifications” has been updated to meet current HRPP standards related to training and qualifications.

• Updated Privacy Intake Form: this is a gentle reminder to please use v4, the most up-to-date version.

REB Application Education: For anyone wishing to obtain basic education in ROMEO and how to submit quality REB applications, please email [email protected] for a link to a video.

For any background information on the HRPP, please see the following memo that was released by Nova Scotia Health Research on July 18, 2023.

WHO ARE WE? The HRPP core team is the leadership team responsible for the development and implementation of the HRPP at NS Health and is composed of the following teams within research administration: Research Quality, Research Ethics, Research Education, and Research Development.

WHAT WE DO: The HRPP Leadership is responsible for the development, writing, and communication of institutional policies, procedures, and processes as they relate to human research protection.  The team has released their first Standard Operating Procedure (SOP) called HRPP-SOP-003 Research Participant Recruitment, located on the Research and Innovation Intranet. More SOPs are being developed, which include a mandate that will speak to our culture and how we operate, processes on data governance, training and qualifications, research approval pathways, and more.

Our HRPP leadership team is dedicated to including you along the way as interested parties (formerly “stakeholders”), ensuring that the processes we document and create meet the needs of our research teams and provide the clarity and transparency required for you to efficiently operate while meeting the National Standards of Canada in Research. 

The HRPP has an email address that is monitored by the HRPP Core Team [email protected].   

N2:

The N2 Atlantic Regional Meeting is being held November 27, 2023, at the Atlantica Hotel in Halifax. The topic is Enhancing the Efficiency if Multi-site Trials in Canada.

Further information about the conference and registration can be found here.

Advanced registration ends November 14^th.

CANTRAIN

Your NS Health Research Education Program has been supporting CANTRAIN – A national clinical trials training initiative which began last summer as a collaboration between NS Health, McGill, Sickids and various other clinical trial locations across the country.

We are happy to welcome the following team members for the CANTRAIN Clinical Trials Training Programs who are based at Nova Scotia Health:

• Dan Lafreniere, Clinical Research Educator.
• Raif Abdullah, Nova Scotia Provincial Coordinator
• Khoa Ha, National Program Developer and Designer

You can participate in a survey from CANTRAIN regarding the roles and responsibilities of research coordinators to help with CANTRAIN development of the training needs. The survey is open until Thursday November 9, 2023

A placebo is used in a clinical trial to test the actual treatment to a treatment that does not have any active substances. It would seem a study participant taking a placebo would not have any changes in the way they feel or how their body reacts. The placebo effect is defined as a phenomenon in which people experience a benefit after taking a placebo.

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