Dear Nova Scotia Health clinical trials community,

Research, Innovation & Discovery is pleased to present you with our inaugural Clinical Trials Corner Newsletter! This newsletter is a new initiative developed by Research Education and Research Quality to keep you informed on topics important to clinical trials such as Health Canada regulations and guidance, ICH-GCP, and TCPS2. You will also find ongoing NSH research related initiatives, institutional policies and SOPs, introduction to new employees, and/or educational opportunities that might be of interest. 

The Clinical Trials Newsletter will be distributed quarterly. If you wish to share ideas and new learnings to other research staff through this newsletter, would like us to address a topic of interest, or if you'd like to provide feedback, email us at CTnewsletter@nshealth.ca.

Human Research Protection Program

The Human Research Protection Program (HRPP) is an institution-wide review and education process for research conducted to ensure the protection of research participants' rights by:

• Safeguarding and promoting the health and welfare of human research participants.
• Providing guidance and support to the research community in the conduct of research with human participants. 
• Assisting the research community in ensuring compliance with relevant regulations
• Providing timely, high-quality review and oversight of human research projects
• Promoting a culture of research excellence

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 will have to certify or re-certify on the new TCPS2 CORE tutorial by December 31, 2022.

Medical device research

Health Canada began a pilot to inspect Medical Device Trials. Many sites across Canada have undergone inspection with a common finding of deficient training of GCP for medical devices. 

We are currently sourcing available options for this training to meet the requirements of Health Canada and will keep you posted, as we do not currently have a formal process for providing GCP for medical device research.

ICH-GCP

You will be pleased to hear that we are moving to an institutional policy requiring ICH-GCP re-certification every three years. If you complete ICH-GCP training through CITI or through Nova Scotia Health Research Education, your certificate will expire in three years.

Formalized guidance on this will be released soon. In the meantime, if you/or the sponsor require proof of our three year policy, please contact Andrea Dean (andrea.dean@nshealth.ca)

From the Health Canada Memo:

What sponsors need to know: 

The period for keeping records starts on the date the record is created. To simplify the process, sponsors may choose to "start the clock" for keeping all study records when the trial is completed or terminated. 

We are consulting stakeholders on the start date through consultations for the plan to modernize the regulation of clinical trials. 

The requirement to keep records for 15 years would apply to sponsors of: 

• Clinical trials of all drugs and natural health products with ongoing record retention obligations prior to February 11, 2022.
• Any new clinical trials authorized on or after February 11, 2022

We will update documents over time to reflect the change to a 15-year record retention period. 

The full memo is available here. 

• There is a toolbox located on the research website that contains useful information and templates for clinical trials. It will continuously be updated, and can be found here.

• The Nova Scotia Health research policies and procedures are currently under review. Completion and sign-off of the annual Nova Scotia Health Research Policy Review Checklist for research employees is temporarily not required and verification of annual completion is not currently part of the Nova Scotia Health research auditing program. Once new research policies and SOPs are published, we will resume the training requirement of research policies for research employees and additional auditing on this training. If you have any questions or concerns, please contact Andrea Dean at andrea.dean@nshealth.ca

• Research teams member can now apply for full access to OneContent in Central Zone. Please use Dr. Adrian MacKenzie, Director of Research, as your approver. We are moving away from research queues for research teams. Queues will continue to be required for study monitors, but will be populated as needed. 
• A reminder to study teams to ensure that the monitor account is active prior to the monitoring visit. 

• A reminder that LMS employee modules must be completed annually

• NPs can be Sub-Is in Health Canada regulated clinical trials at Nova Scotia Health. The statement is located in the research toolkit.



• The N2 Clinicial Research Coordinator Course is available in CITI. After logging in:
• Click "view courses" next to Nova Scotia Health
• Scroll down to "add a course"
• Add Clinical Research Coordinator course
• Choose the option that applies

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