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!

Research Sharepoint: 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!

ICH-GCP E6 (R3):

ICH-GCP E6(R3) is expected to be released in early 2025. Research Quality and Education will be attending global webinars to learn about the changes and the expected impacts on sponsors, sites, and vendors. 

Source documentation for regulated clinical trials: Did you know?

Source documentation will be referred to as source records in ICH-GCP E6(R3).

Source records are original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of the media used. This may include trial participants’ medical/health/notes/charts; data provided/entered by trial participants (e.g. electronic patient-reported outcomes (ePROS); healthcare providers’ records from pharmacies, laboratories, and other facilities involved in the clinical trial; and data from automated instruments, such as wearables and sensors.

Every data point recorded in the case report form (CRF) must have a source record.

Source records provide evidence for the existence of the participant and substantiate the integrity of the data collected.

Source records should be signed and dated by the person collecting, recording, reviewing and/or assessing the information or data. Health Canada recommends alternative verification methods consistent with ICH-GCP may also be acceptable (example: documentation in a progress or clinic note).

HRPP 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.

The next session is November 28 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-005 Training and Qualifications 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. 

CBC Documents on Phase 1 Clinical Trials: Bodies for Rent:

A recommended documentary for those who are interested in the perspective of phase 1 trial participants who are volunteering their bodies to science as a way of living and the ethical dilemma that it brings. 

You can watch for free when you sign up for an account on CBC Gem: https://gem.cbc.ca/bodies-for-rent. Enjoy!

Education Lunch and Learns:

We heard you and we are pleased to announce that Research Education Lunch and Learns are back!

The first session will be held on Tuesday, December 10th from 12-1pm and the topic will be Common Internal Audit Findings. You can join the meeting here: 

Click here to join the Research Education Lunch and Learn via Teams

Please reach out to Research Education at ResearchEducation@nshealth.ca if you have any idea of a future topic you would like covered.

Upcoming applications:

New Investigator in Addictions and Mental Health Grant:

The New Investigator in Addictions and Mental Health Grant supports early-career researchers who are engaged in mental health and addiction research that is focused on equity-deserving groups in Nova Scotia. For the purposes of this grant, equity-deserving groups are defined as, but not limited to: Mi’kmaq/Indigenous Persons or Communities, African Nova Scotians/Persons of African descent, Racialized Persons, Newcomers, Persons with Disabilities, the 2SLGBTQIA+ community, Acadian/Francophone individuals, and residents of rural areas.

This one-time grant will provide up to $100,000 over two years for researchers who are within the first five years of their first academic appointment.

Details: New Investigator In Addictions And Mental Health Grant – Research Nova Scotia (researchns.ca)

IMPORTANT DATES:        

Applications Open: Thursday, October 10, 2024

Webinar: Wednesday, October 23, 2024 at 1:00 PM (ADT)

Expression of Interest Deadline: Thursday, November 7, 2024 at 1:00 PM (AST)

Invitation to Full Application: December 2024

Full Application Deadline: Thursday, February 13, 2025 at 1:00 PM (AST)

Anticipated Notice of Funding Decision: April 2025

Anticipated Start of Funding: April 2025

AWARD TERM: Up to 2 years | AWARD AMOUNT: Up to $100,000

CIHR Planning and Dissemination Grants:

The specific objectives of this funding opportunity are to support:

• Planning activities, partnership development and to increase understanding of the health research landscape that will contribute to the advancement of research consistent with the mandate of CIHR; and
• Dissemination events and activities that focus on the communication of health research evidence to the appropriate researcher or knowledge-user audiences, tailoring the message and medium as appropriate.

The total amount available for this funding opportunity is $1,970,000, enough to fund approximately 75 grants. The maximum amount per grant varies by the sponsoring Institute and Initiative.

Details: ResearchNet - RechercheNet

IMPORTANT DATES        

Full Application Deadline: November 19th, 2024

Anticipated Notice of Funding Decision: March 2025

Anticipated Start of Funding: April 2025

AWARD TERM: 1 year | AWARD AMOUNT: Varies

Q: What do you call an alligator in a vest?

A: An Investigator!

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