Dear Nova Scotia Health Clinical Trials community,

Thank you for tuning into the CT Newsletter. The newsletter is our primary method for dissemination of new information, reminders, and updates to the research community. We hope you find our newsletter both helpful and informative. We welcome your comments, suggestions, and content for future editions.

Investigators initiating new studies are encouraged to reach out to Research Quality for a consultation during the planning phase of a study, or with any questions or comments regarding research and clinical trials. You can reach us at ResearchQuality@nshealth.ca. We are here to support you!

Reminder:

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.

Good Documentation Practices (GDP):

A friendly reminder to always use GDP. Here are some helpful guidelines to help you with ALCOA+C. 

Adverse Drug Reaction (ADR) Reporting:

Did you know that if an ADR is reported to Health Canada as part of clinical trial that required an NOL or ITA, the ADR should not be reported locally in SIMS? This would be a duplicate report of the same ADR to Health Canada. It is the Sponsor’s responsibility to report any serious and unexpected ADRs to Health Canada that occur either inside or outside Canada as part of a Clinical Trial.

Consenting participants using REDCap:

When creating eConsent in REDCap, ensure the ‘subject signature field’ is not toggled off from the participant’s perspective. If it is, the participant’s signature will not show up! It is best practice to test the functionality of the eConsent before distribution.

Standard Operating Procedures (SOP):

Two new HRPP SOPs have been issued!

HRPP-SOP-008 Addressing Research Participants Inquiries and Concerns, and HRPP-SOP-009 Assessing and Reporting Safety and Deviations can now be found here, along with previously issued SOPs. Stay tuned for more SOPs to be added in the coming months.

Access to Personal Health Information (PHI) for Research Purposes:

A new Access to PHI consent form and process for signed forms are on the horizon.

The new Access to PHI consent form incorporates an option for NovaStudies Connect. More information to follow in the coming weeks.

Work Instructions:

A work instruction is a document created for a particular research team that details how a procedure may be carried out in that research team. It does not apply to any other team. Responsibility for the content, including ensuring alignment with existing direction and revising as needed, rests with the research manager or appropriate research team member. Work Instructions describing the PHI used are submitted to the REB before the process is implemented.

As more HRPP SOPs are published, work instructions are encouraged as a routine for teams to define their specific processes. Please note that these work instructions supplement institutional SOPs, and do not replace the related SOP. 

As we continue to advance our clinical research efforts, it is important to register your clinical research studies on NovaStudies Connect. NovaStudies Connect provides every Nova Scotian with the opportunity to actively search for clinical research studies taking place within the province and provides patients with the ability to engage directly with the research team. Registering your studies on NovaStudies Connect not only enhances recruitment efforts but also showcases all the research being conducted at Nova Scotia Health.

All studies registered on clinicaltrials.gov can be pulled directly into NovaStudies Connect; REB approval is not required. Only pre-screening questionnaires need to be reviewed by the REB. Should you have any questions or need assistance with the registration process, please don’t hesitate to reach out to rebecca.robichaud@nshealth.ca.

We are currently integrating DCT capabilities into the NovaStudies Connect platform. We invite research teams to participate in early DCT review sessions and contribute to the design process. Your valuable insights and feedback are appreciated! Meetings are scheduled for 30 minutes every three weeks with a standing agenda:

• Review DCT Workflow(s)
• User workflow diagrams 
• Product of design demos (within the app or prototypes) 
• Gain any insights and feedback.
• Open forum
• Questions or any additional suggestions for improvement 

If you are interested, please reach out to researchoperations@nshealth.ca.

As a reminder, weekly digest emails are sent to all users assigned to a study in which new candidates have submitted their interest via NovaStudies Connect. Users receive a list of studies with the count of new participants (notifications) in those studies from the last 7 days. 

• Only users assigned to studies that have new notifications in the last 7 days will receive an email.
• You will not receive an email if your studies have no new notifications.
• The email will come from messages@sciteline.com (be sure to check your junk folder).

Institutional Biosafety Committee: Research Operations is establishing a research-specific institutional Biosafety program to attract new clinical trials (e.g., gene therapy, and other precision medicine). This will help build capacity to better position Nova Scotia Health to deliver precision medicine to Nova Scotians in the future. Part of this initiative includes establishing the Institutional Biosafety Committee (IBC) to review biosafety for clinical trials. Currently, we are looking for individuals who may be interested in being members of the IBC. Anyone who may be interested can email researchoperations@nshealth.ca.

One Person One Record (OPOR):

What's in it for researchers, clinicians and patients?

• OPOR is a seamless electronic ecosystem inhabited by health care and research records for all Nova Scotians with one point of access for health care teams and/or researchers;
• User-friendly, modular in structure, compliant with regulatory and privacy laws;
• Enables full digitization and automation of current paper/manual/fax processes and medical records;
• Provides access to clinical information from across the province in a single electronic platform.

PowerTrials and PowerPlans: focus on research teams and patient access to clinical trials

• PowerTrials is a functional module embedded within the OPOR CIS used to create and maintain protocol information and enrollment activities for research studies, including clinical trials.
• Within PowerTrials, one of key features is a PowerPlan: It represents an individual order set or cycle of treatment (imaging, labs, chemotherapy, medication), in other words, a treatment plan.

How and when will OPOR be deployed?

• Clinicians, investigators, and their associated teams, will all receive thorough training, and ongoing support as elements of OPOR are being tested, rolled out, and fully implemented. 

CANTRAIN – Helpful tips

• How to turn off the blackboard LMS email notifications.
• How to print certificates in CANTRAIN.

Register for CANTRAIN here: https://wecantrain.ca/registration-cttp/

A reminder that there is a delay in getting a username and password (up to 48 hours). If needed sooner, please email andrea.dean@nshealth.ca

Are you interested in becoming a CANTRAIN mentor? Email andrea.dean@nshealth.ca to get connected.

Have you already tried out CANTRAIN? We’d like to hear from you! Please send your feedback to andrea.dean@nshealth.ca.

Coming Soon:

You asked, we heard! The Research Ethics Board Executive Committee has taken the significant task of updating and modernizing the entire wording of the informed consent form (ICF) templates to reflect grade 8 reading level, starting with the Interventional ICF.  

In addition, we are integrating the new FDA guidance documents released earlier this year within the interventional ICF: Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards. This guidance aims at facilitating the understanding of the ICF, serving a similar purpose to the letter of intent that some of you are familiar with for industry-sponsored studies.

We expect to release the updated ICFs by the end of the summer. Communication for the release will be posted in the News and Updates section in the Attachment tab within ROMEO, announced at Manager’s meetings, and in the next edition of this newsletter.

The FDA approved the first genetically engineered drug, named Humulin, in 1982. Scientists inserted human genes responsible for insulin production into E. coli bacteria and stimulated the bacteria to synthesize insulin, resulting in the creation of Humulin.

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

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