Dear Nova Scotia Health Research Community,

In response to the recent process audit, the title and frequency of our newsletter has changed to reflect more of our research community. The former “Clinical Trial Newsletter” has been re-branded to “Research Bulletin” and will be published on the first week of each month.

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 are pleased to announce the promotion of Courtney Heisler from Manager of Research Operations to the position of Director of Clinical Research Operations. Courtney has a background in Community Health and Epidemiology from Dalhousie University and data analytics training through Cornell University. Since joining our team in 2022, her ability to foster collaboration and drive results has made a significant impact on research initiatives at Nova Scotia Health.



During Courtney's parental leave, we welcome Dr. Walead Ebrahimizadeh as the Interim Director of Research Operations. Dr. Ebrahimizadeh has over a decade of research experience in academic, biotech, and healthcare sectors.

We are currently in the process of developing a Research SharePoint page that will host research SOPs, templates, forms, communications, and much more. Everyone in the Nova Scotia Health research community will have access to the page. Stay tuned for more info!

Thank you to all 112 of you who completed the 2024 Process Audit survey! Your voices are being heard and the results are helping make a difference. We are putting your ideas into action. We will plan to repeat the survey again next summer in hopes that there will be a greater awareness of the HRPP, the SOPs, and the upcoming Research SharePoint page.

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.

Internal Audits:

Interested in finding out more about our internal audits? Reach out to ResearchQuality@nshealth.ca for more info!

Monitor Queue Reminders:

• Queues for monitors are temporary (30 days once activated)
• Queues should be requested at least two weeks prior to the monitor visit.
• The Request for Monitor Access to Patient Records needs to be completed for each monitoring visit.
• The monitor is instructed to empty encounters by using the ‘complete’ button once the information has been reviewed.
• The database coordinator is notified when the monitoring visit is complete to ensure the queue has been emptied.

Data Safety Monitoring Board:

Please ensure you are submitting all DSMB reports to the REB as soon as they are received by your team.

 Lunch and Learn sessions:

The Human Research Protection Program (HRPP) Team is going to be hosting virtual Lunch and Learn Sessions on the 4th Thursday of every month starting October 24th from 12:10-12:55 pm. The team will be covering the HRPP and review all the new institutional SOPs and Policies as part of this program. These Lunch and Learn sessions will count towards your research training. More information will follow. Sessions will be recorded and saved on SharePoint in case you are unable to attend live.



Invites to the first session were sent out October 1. Please contact HRPP@nshealth.ca if you did not receive the invite.

New HRPP SOP:

HRPP-SOP-004 Content Development and Obtaining of Consent is now published and can be found here, along with previously issued SOPs. Stay tuned for more SOPs to be added in the coming months. 

New Interventional Consent Form Template:

A new interventional informed consent form (ICF) template is due to be released October 1. Here are the major changes you can expect:

• The entire consent template wording was revised and verified for grade 8 reading level
• The ICF will now open with an introductory paragraph about the study. This is meant to serve as a cover letter/letter of intent/synopsis/executive summary of the consent form describing what the study is about. 
• A table of contents: for large ICFs, we recommend using a table of contents to facilitate readability or information searching for participants.
• Sections moved around to provide a better flow of information.
• New Optional Sub-Study section: to facilitate information processing, we moved all the optional sub-study wording into one section with sub-headers for additional tasks, risks, etc. 
• Contact information: The REB will now require that the name and contact information be typed for greater legibility. Stickers with contact information for teams with turnover will also be acceptable.
• Signature page re-design: the signature page is now in a table format, which should be easier to use. We’ve also included check boxes, which should help with the informed portion of the consent.

ROMEO’s NEWS and UPDATES Link:

The REB and HRPP will now be using the “News” and “Useful links” links within ROMEO to communicate relevant information as it relates to your study approval process at NS Health. Please check these links for updates before you submit or for resources.  

New form: The Laboratory Research Support Study Information Form has recently been updated. You can also find it in ROMEO. Please ensure you are using the updated form.

Workshop:

PowerTrials, Clinical Information System, and integral module of OPOR, has reached a point where PI engagement is required to fine-tune the functionality of the platform. The OPOR team and Oracle Health, in collaboration with the NSH team overseeing the initiative, scheduled 3 interactive workshops on September 13, 16, and 20.

The first two workshops saw excellent attendance from over 30 research managers, PIs, and NSH managers. The workshops include introduction to OPOR and PowerTrials followed by a live system demo. NSH team is working on an FAQ document capturing workshop questions.

More workshops may be scheduled for October.

Upcoming NovaStudies Connect training sessions:

• October 7, 1:30 - 2:30 p.m.
• October 21, 10:00 - 11:00 a.m.

Please contact Rebecca Robichaud (rebecca.robichaud@nshealth.ca) to register

Study Status:

A new feature will be introduced to the NovaStudies Connect PRM platform during the week of September 30.

This newly derived Study Status feature will simplify the process of setting study and site statuses. All sites added to studies will require a recruitment status to be set.  Users will no longer need to manually determine, nor update, the study-level status of ongoing studies. Users will maintain the status for their own site, and the study status will be calculated automatically based on the status hierarchy and validation rules outlined in the figure below. When a study is closed, additional closed statuses can be selected manually.

As a reminder, any site with a site-level status of Not Yet Recruiting, or Recruiting, will be available to contact through the participant search portal. Sites with any other status will not be available to contact through the search portal.

Summary of Updates:

Site Statuses: Setting a site status will be a required field when adding a site to a study.

Ongoing Study Statuses: Users will not be able to edit an ongoing study-level status independently from site statuses. The study status will be calculated automatically based on the site status.

Closed Study Statuses: Once all study sites are set as ‘Closed for Recruitment,’ users with contributor and owner permissions will have the following options:

1. leave the auto-set study status as ‘Closed for Recruitment,’
2. manually close out the study and choose from one of the following closed statuses: Completed, Suspended, Terminated.

Please review each of your studies to ensure that the site-level statuses are accurate.

If you need to make any updates, a guidance document for updating study and site statuses can be found here: How-to: Changing Study and Site Statuses | Scribe (scribehow.com)

Please reach out to Rebecca Robichaud (rebecca.robichaud@nshealth.ca) if you need any assistance or have any questions.

CANTRAIN

CANTRAIN is continues to be available for registration through the website portal: https://wecantrain.ca/registration-cttp/

Courses available include Welcome and Orientation (Level 1), Regulatory compliance TCPS, Division 5 and ICH-GCP (Level 2) and eleven clinical trial training courses (Level 3) which make up the remainder of the Common Core Foundations.

Please note all registered learners in CANTRAIN must complete Common Core Foundation courses by October 31st due to a large-scale evaluation of the program taking place. Accounts will be deactivated of registered learners who have not completed the Common Core. 

To learn more about CANTRAIN, we welcome you to a lunch and learn session on: October 15 from 12 -1pm hosted by Srijain Shrestha, CANTRAIN Mentorship Coordinator. You can join the session on Microsoft Teams using this link: Join the meeting now.

Privacy:

Questions about privacy and research? We are partnering with Research Privacy to bring you answers! Please fill out this anonymous survey so we can best address your biggest questions: https://forms.office.com/r/bL3Dq4Pptu

High School Co-op:

You may notice some new faces around the CCR over the next few months! Research Education is pleased to announce our new cohort of three high school students making their rounds to find out just what a career in clinical research might look like. This comes in partnership with volunteer services’ high school co-op program. If you or your team are interested in hosting the high school students for a day, please reach out to researcheducation@nshealth.ca. 

Need GCP or Division 5 Training?

Please reach out to researcheducation@nshealth.ca so we can set up a course date together!

Upcoming Applications:

Research Nova Scotia recently opened their Peer Review Observer Program for students and early career researchers. This is a great opportunity for new investigators to see a review committee in action! More details here

• See attached for upcoming grant deadlines
• TUTOR-PHC (Transdisciplinary Understanding and Training on Research – Primary Health Care) program has begun their call for applications to the 2025-2026 program. The deadline is December 13, 2024. For more information and the application package visit their website: https://www.schulich.uwo.ca/tutorphc/index.html

Did you know that the first documented controlled clinical trial was run by Dr. James Lind in 1747? Dr. Lind hypothesized that acids would cure scurvy, so he tested his theory by treating groups of British Navy sailors with various acidic agents, including oranges and lemons. He found that the group who ate the citrus fruits recovered better from their scurvy than other groups. It wasn’t discovered until later that it was the vitamin C in the fruits that was curing the disease.

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