Dear Nova Scotia Health Research Community,

The newsletter is the primary method for dissemination of new information, reminders, and updates for the research community. 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 comments regarding research and clinical trials. You can reach us at ResearchQuality@nshealth.ca. We are here to support you!

We’d like to help celebrate your team's wins and successes! Please forward the information to ResearchQuality@nshealth.ca and we’ll include it in the next newsletter.

Did you know?

Nova Scotia Health Authority is the official name of the institution for contract and legal purposes. Research contracts and legal are working on a document with more detail on this topic, stay tuned.

Follow-up from education session on common audit findings

There was discussion around the terminology “Enrollment” Here is a definition:

Enrollment: “The over-arching term that includes study participants going through recruitment, providing consent to participate, undergoing screening, and meeting all inclusion and exclusion in order to enter the active phase of the protocol (for example randomization and receiving the intervention).”

Enrollment is a process. The Investigator must confirm all the above enrollment activities have been met before the participant enters the active phase of the study. At this point, the participant has been enrolled into the study.

ICH-GCP E6(R3)

ICH-GCP E6 (R3) was published on January 6, 2025. There is uncertainty about when Health Canada will implement ICH-GCP E6(R3), however, industry Sponsors may start implementing the new guidelines before Health Canada. You may start receiving requests from Sponsors to implement changes. 

ICH has indicated there will be training provided and N2 will be in contact with CITI to update the available training. We will keep you posted.



WCG conducted a webinar on January 29 titled ICH (R3) is here: What You Need to Know. The recording of that informative webinar can be accessed here.

Upcoming HRPP SOP Lunch and Learns

Join us virtually on Teams to learn more about our institutional processes in research. HRPP Lunch and Learns occur every 4^th Thursday of every month from 12-1 pm. Share the link below with your teams.

February 27^th: HRPP-SOP-003 Research Participant Recruitment

March 27^th: HRPP-SOP-008 Addressing and Reporting Safety and Deviations

April 24^th: HRPP-SOP-006 Management of Participant Privacy in Research

Teams link

Meeting ID: 238 800 021 687

Passcode: J8k9XP 

New HRPP SOPs

HRPP-SOP-012 Compliance with the HRPP and HRPP-SOP-013 Managing Investigational Product Administration and Compliance are now published and can be found here, along with previously issued SOPs. Stay tuned for more SOPs to be added in the coming months!

Does your team need an SOP that has not yet been written by HRPP? Please reach out to HRPP@nshealth.ca with your suggestions.

Submitting an IT ticket to request access to clinical applications that contain PHI

Please complete the Request for access to PHI survey and attach the PDF of your responses to the IT request. This process aims to increase efficiency by ensuring that tickets are submitted with the proper documentation.

*New* Access to Personal Health Information Form

The newly approved Access to Personal Health Information (PHI) form is now available and can be found on the REB Website under the Informed Consent Form Templates section. It can also be found in ROMEO. If you are going to be consenting participants for access to their PHI for research purposes, please begin to use this form moving forward. Tablets are also available for teams to use for direct participant entry into NovaStudies Connect. More information regarding the change in process will follow.

NovaStudies Connect Training Session

We will be holding NovaStudies Connect training sessions on February 10^th and February 24^th from 1PM-2PM via Teams. If you have new research staff on your teams that require training, please reach out to researchoperations@nshealth.ca. 

NovaStudies Connect Expands with Decentralized Clinical Trial Capabilities

We’re excited to announce the upcoming release of the Decentralized Clinical Trials (DCT) module, seamlessly integrated into the NovaStudies Connect platform. Designed to enhance flexibility for researchers and participants, the DCT module supports hybrid and fully decentralized study protocols, offering:

• Participant module app – Provides an intuitive interface for participants to complete tasks, stay informed and engage with their study
• eConsent – Securely review and consent candidates virtually
• Visit scheduler – Plan virtual, in-person, or phone visits with ease
• eCRFs – Capture data digitally for all visit types
• ePROs – Enable participants to submit patient-reported outcomes via the app
• Virtual visits – Conduct remote visits conveniently
• Notifications – Send reminders for visits and assessments directly to participants

Launching early 2025, the NovaStudies Connect DCT module will be introduced through virtual informational sessions hosted by Sciteline. Stay tuned for dates and details or contact rebecca.robichaud@nshealth.ca  for more information.

Education Lunch and Learns:

We are having great success with the re-launch of the Research Education Sessions, including our new certificate system. If there are previous sessions you have attended, but did not receive a certificate and need one for CE credit, please email researcheducation@nshealth.ca.

We would love to hear specific topics you would like to see in the Research Education sessions moving forward, so we can build the program that will meet your expectations. Please email researcheducation@nshealth.ca with topics of interest, and we will do our best to meet your demands!

 High School Co-op Wrap-up Event

Thank you to everyone who attended our High School Co-Op wrap-up event on Jan. 8th. We had a wonderful turn-out which is fitting given the incredible support we have from all of you regarding this program. A huge thank you once again for your continued support.  

We plan to bring in 3 new students between March – May 2025 and we will be reaching out later this month for volunteers. For inquiries: researcheducation@nshealth.ca

CANTRAIN

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”.

Watch this 2-minute video about CANTRAIN to learn more

Registration for the CANTRAIN Clinical Trial Training Platform can be found HERE.



Courses available include:

1)     Welcome/Orientation to CANTRAIN

2)     Regulatory modules of ICH-GCP, Division 5 and TCPS

3)     The 11 CANTRAIN Common Core Foundation modules

The CANTRAIN Common Core Foundation is a fundamental (basic or entry level) that comprises eleven courses designed to provide learners of various profiles with a strong knowledge baseline of key concepts in the conduct of clinical trials involving human participants. This is information everyone involved in clinical trials should know and understand, regardless of role. Through this level CANTRAIN modules are tailored, sequenced and assembled in such a way to address the needs for a wide variety of learners (students, clinical research professionals and trialists) and are designed for new leaners.

Curriculum of Common Core Foundation:

1. Study Designs and Clinical Trial Phases
2. Drug Discovery and Development Process
3. The Clinical Trial Protocol
4. Patient Engagement in Research
5. Roles and Responsibilities in Clinical Research
6. Good Documentation Practices
7. Ethics and Informed Consent
8. Participant Recruitment
9. Participant Safety and Adverse Events
10. Data Management in Clinical Research
11. Study Oversight and Monitoring

We highly encourage Research Managers to direct new hires to these valuable training modules as the courses are specifically designed for people new to Clinical Trials. Courses 1-3 are a simple yet informative overview/intro for employees new to clinical trials and will supplement the Nova Scotia Health Sink or Swim course. 

CANTRAIN Studentship Awards

The CANTRAIN studentship applications open March 1^st and close May 31^st. These awards are open to Masters, Doctoral and Postdoctoral students.

Award Overview:

MASTER'S: Up to $17,500 with 2* x ($8,750)

DOCTORAL: Up to $35,000 with 2* x ($17,500)

POSTDOCTORAL: Up to $42,500 with 2* x ($21,250)

* from CTTP award amount matching co-funding offered by provincial partner

CANTRAIN Collaborative Training Hub

The Collaborative Training Hub is an open access launchpad to quickly access unique clinical trials training resources and opportunities. These curated mini-series offer you access to high-quality learning material produced by CANTRAIN or by other Canadian leaders in the clinical trial landscape. All training is available on-demand via computer, tablet, and phone, and does not require registration or login.  

CANTRAIN and Dalhousie Education Session

Introduction to Cantrain! Facilitated by Lisa Goos, Cantrain COO and Jodi Langley, Cantrain Post-Doc award recipient. This session will provide an overview of Cantrain and explain how it is supporting clinical trial education and training in Canada, including student funding opportunities. The session will also provide an overview of what it is like to be funded through Cantrain as a student (presentations, webinars, educational materials, mentor support and the annual conference).

Wednesday March 19, 2025

10:30am-12:00pm

Virtual (MS Teams)

Register Here - https://surveys.dal.ca/opinio/s?s=79110

Biosafety course

Interested in enhancing your knowledge on Biosafety? Dalhousie is offering a 6-hour course that can be completed at your own pace called Biosafety Principles and Practices.

To learn more, visit the link below:

OLCD-EHAS0015 Biosafety Principles and Practices | Dalhousie University

Nova Scotia Health Research Fund Team Success Stories

Congratulations to Dr. Christie’s team on the successful completion of their project “Occult bacterial discitis and Modic change in patients receiving surgical therapy for lumbar disc herniation”. The project aimed to “assess the relationship between occult bacterial discitis, modic change (MC) of the spine on magnetic resonance imaging (MRI) and clinical outcomes following surgical treatment of lumbar disc herniation (LDH).” The team report that they succeeded in the original research goals. They enrolled 81 patients, but did not find an association between modic change, disc sample bacterial cultures, and clinical outcomes. While the results of the study are negative, the team note they will significantly add to the scientific literature and may garner interest from the international scientific community. The team report that the successful completion of this study is a “testament to the beneficial impact of inter-disciplinary collaboration (e.g. neurosurgery, orthopedics, microbiology, nursing, radiology). This partnership among involved teams sets the stage for future collaborative efforts and has strengthened the local research network.”

o  “Modic change is not associated with occult discitis or poor clinical outcome among patients surgically treated for lumbar disc herniation: prospective cohort study”. Published Abstracts: (39) “Exploring the Bacterial Hypothesis of Low Back Pain: A Prospective Cohort Study”. Mark A. MacLean, L. Julien, G. Patriquin, J. Leblanc, R. Greene, J. Alant, S. Barry, R. A. Glennie, W. Oxner, S.D. Christie. Can. J. Neurol. Sci., 2023, 50(S2), S96.

o  “Exploring the Bacterial Hypothesis of Low Back Pain: A Prospective Cohort Study”. Mark A. MacLean, L. C. Julien, G. Patriquin, J. Leblanc, R. Greene, J. Alant, S. Barry, R. A. Glennie, W. Oxner, S.D. Christie. (Can. J. Surg., 2023, 66(4 Suppl 1), S18; doi:10.1503/cjs.006523).

Congratulations to Dr. Manal Elnenaei on the completion of the project entitled “Defining the genomic and epigenomic landscape of disease evolution in multiple myeloma.” Dr. Elnenaei reported that her objectives were met from the project. The goal of this research was to establish a ‘next generation’ sequencing approach that would enable clinical stratification of patients with multiple myeloma into low and high-risk groups. It is hoped that these results will pave the way for the international community to move away from using FISH as the gold standard for molecular stratification of multiple myeloma and focus on more clinically impactful cost-effective approaches.  The study led to increased collaborations with Dalhousie researchers and supported a medical student’s work. The team hopes to build on the project and expand collaborative efforts to address the significant gaps in myeloma research, both generally and within Canada specifically.

o  Cutler SD, Knopf P, Campbell CJV, Thoni A, Abou El Hassan M, Forward N, White D, Wagner J, Goudie M, Boudreau JE, Kennedy BE, Gujar S, Gaston D, Elnenaei MO. DMG26: A Targeted Sequencing Panel for Mutation Profiling to Address Gaps in the Prognostication of Multiple Myeloma. J Mol Diagn. 2021 Dec;23(12):1699-1714. doi:10.1016/j.jmoldx.2021.08.011.

Funding Opportunities

1. We are launching the Health Equity Fund please see attached for more information.
2. Upcoming funding opportunities deadline list for Feb-Apr, found here.

It is thought that the largest and most expensive phase III Clinical Trials ever conducted were in 1954 and 1959, involving 1.8 million participants in North America and 10 million in Russia, known as the Polio Vaccine Field Trials!         

Thank you for reading the Research Bulletin! The next edition will be March 2025.

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