Operating Grant: Clinical Trials Projects (2023)

Eligibility

For an application to be eligible, all the requirements stated below must be met:

1. The Nominated Principal Applicant (NPA) must be one of the following:
   1. an independent researcher or a knowledge user, affiliated with a Canadian postsecondary institution and/or its affiliated institutions (including hospitals, research institutes and other non-profit organizations with a mandate for health research and/or knowledge translation).
      • If the NPA is a knowledge user, there must be at least one Principal Applicant (PA) who is an independent researcher.

      OR

   2. an individual affiliated with an Indigenous non-governmental organization in Canada with a research or knowledge translation mandate.

      OR

   3. an Indigenous non-governmental organization in Canada (including community organizations and regional health authorities) with a research or knowledge translation mandate.

2. The NPA must have their substantive role in Canada for the duration of the requested grant term.

3. The Institution Paid must be authorized to administer CIHR funds before the funding can be released (see Administration of Funds).

4. The applicant team must include at least three additional applicants in either PA or Co-Applicant (Co-A) roles, with a minimum of one individual from each of the three categories listed below:
   1. Early career researchers
   2. Knowledge users (KU), including but not limited to:
      • Health care professionals/providers with a focus on the primary care system (e.g., physicians, nurses, occupational therapists, pharmacists, social workers, physiotherapists, psychologists, Elders and/or Traditional Counsellors, or other health professionals/providers);
      • Health care system decision makers and administrators (i.e., individuals empowered to engage with the research project and serve as a conduit of information to and from their respective health system, health care institution, health care centre [including health or wellness centres on-reserve or in urban centres], etc.).
   3. People With Lived/Living Experience (PWLE); in the context of this funding opportunity, this includes individuals with personal experience of a health issue (patients) or having been a clinical trial participant, or formal and informal caregivers, including family and friends, and organizations representing PWLE.

5. For any research involving Indigenous Peoples (First Nations, Inuit, and/or Métis), the research team must include:
   1. At least one applicant (NPA or PA) who self-identifies as Indigenous (First Nations, Inuit or Métis) and/or provides evidence of having meaningful and culturally safe involvement with Indigenous Peoples (see How to Apply for more details).
   2. An Indigenous Elder and/or an Indigenous Knowledge Keeper identified on the application as a Principal Knowledge User, Knowledge User or Collaborator.

6. At minimum, the NPA must have successfully completed one of the sex- and gender-based analysis training modules available online through the CIHR Institute of Gender and Health and submit a Certificate of Completion. Select and complete the training module most applicable to your project. All team members are encouraged to review the page "How to integrate sex and gender in research" on the CIHR website. See How to Apply for more details.

7. An individual is permitted to submit a maximum of two letters of intent to this funding opportunity as an NPA. If more are submitted, CIHR will consider only the first two letters of intent submitted based on timestamp of submission, others will be withdrawn from the process.

8. Applicants must comply with CIHR's Policy on Identical / Essentially Identical Applications.

Summary

The Clinical Trials Fund (CTF) is an integral part of Canada’s Biomanufacturing and Life Sciences Strategy (BLSS).

This funding opportunity will support projects relevant to at least one of the following research areas:

• Clinical trials for new or repurposed drugs (including vaccines and biologic drugs) and medical devices (such as diagnostic tests) to prevent or respond to health emergencies*.
• Early phase (pilot, Phase 1 and Phase 2) clinical trials of safety and efficacy to support the development and commercialization of new health products with high potential to solve current and future health challenges (such as pandemics, antimicrobial resistance, and other health emergencies)
  • New health products of particular interest for this opportunity include those in emerging technology areas (e.g., precision medicines, including cell and gene therapies, RNA, and viral vectors, and monoclonal antibodies).
  •  

Scope

• Applicants must clearly outline how the proposed project falls within scope as determined by the information below. Unless otherwise noted, all are considered requirements which will be considered in the Review Process and Evaluation.

• CIHR defines a clinical trial as “a research study involving human participants that evaluates the safety and/or effects of one or more interventions on health outcomes”.
• Specifically, CIHR will support research teams to conduct clinical trials that address the research areas and objectives outlined in this funding opportunity and that will contribute to the creation and use of health-related knowledge, so that the outcomes and health benefits of these trials can be applied to Canada's diverse population. Biomedical and pre-clinical research are not eligible for this funding opportunity.
• Applications must include a single clinical trial only and must not be a program of research that proposes multiple independent clinical trials (that is, eligible applications do not include research networks or platforms, but can include an adaptive platform trial and other designs).
• To support a broad range of research projects, principal investigators and co-investigators funded in the first CTF Projects funding opportunity are not eligible to submit applications for the same or similar projects to this funding opportunity.
• While proposed projects are not required to include international collaborations, they are welcomed and encouraged. International collaboration includes either the expansion of an international trial to Canadian sites, or international trials led by Canada-based researchers. Where a trial with Canadian leadership is proposed but with no Canadian sites, the application must provide a rationale for how the proposed project either supports the continued development of a Canadian innovation or benefits people who live in Canada.
• In line with the overall ecosystem-strengthening objectives of the BLSS, applicants are strongly encouraged to develop connections and partnerships with other projects and initiatives supported through the BLSS, particularly those previously funded through the CTF.

Overhead

25% 

An additional amount valued at 25% of the total of each grant will be made available to the respective host institutions to cover the indirect costs of research as this opportunity is not eligible for consideration in the Research Support Fund program. These funds will be disbursed automatically to the host institution of the successful Nominated Principal Applicant (NPA) and must not be included in the budget request. It is incumbent on the successful NPA's host institution to distribute the indirect costs funding to other Institutions/Organizations involved in the funded projects. See the How to Apply section for more information.

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

RSO final internal review deadline

Program application deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Postdocs, students, and trainees: For fellowships and externally-sponsored research training awards or opportunities, you must complete the Research Funding Application Approval (RFAA) Trainee PDF form, and submit it, along with a complete copy of the application, to Research Services at rsotrainee@ucalgary.ca. Trainees should not use RMS at this time.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via either RMS or the RFAA Trainee form, in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

Webinar

CIHR will be hosting the following webinars to support participants with the requirements of the funding opportunity “Operating Grant: Clinical Trials Projects, Information Webinar for Applicants” and to answer questions on how to apply.

English Sessions 
Duration: 60 minutes
When: Tuesday, July 25, 2023 at 11:00 AM MT | Join
When: Wednesday, August 2, 2023 at 11:00 AM MT | Join

Submission Process

LOIs, plus approvals in the Research Management System (RMS), will be required by RSO by noon, August 17, 2023. Please be sure to select "Submitted for approvals" (Under Save & Progress) in RMS in good time to allow for approvals from your Department Head and/or ADR prior to the Research Services deadline. Consult your department and faculty for more information on their approval processes and timelines. A step sheet for creating an LOI record in RMS is available in the Resources section below.

Once RMS approval is obtained for your LOI, you may proceed with submitting to CIHR through ResearchNet by 6:00PM Calgary time on August 22, 2023.

Invited to Full Application

Full applications, plus approvals in the Research Management System (RMS), will be required by RSO by noon, November 16, 2023. Please be sure to select "Submitted for approvals" (Under Save & Progress) in RMS in good time to allow for approvals from your Department Head and/or ADR prior to the Research Services deadline. Consult your department and faculty for more information on their approval processes and timelines. A step sheet for creating an application record in RMS is available in the Resources section below.

Do not submit through ResearchNet until RSO's signature has been granted. 

Once institutional signature has been obtained, RSO will return a scanned copy of the CIHR signature page to NPA via email. Upload the CIHR signature page including the routing slip in the Print/Upload Signature Pages task in ResearchNet by 6:00PM Calgary time on November 21, 2023.

RESOURCES

Support for projects involving Indigenous Research:

Support with the development of your grant application is available internally through the Indigenous Research Support Team (IRST). Applicants can reach out by email to IRST at IRST@ucalgary.ca in advance of the RSO internal deadline. For more information about IRST, please visit the IRST webpage.

Support for Knowledge Engagement:

Support for knowledge mobilization/engagement/translation is available internally through the Knowledge Engagement Team. Applicants can reach out by email to the KE team at knowledge.engagement@ucalgary.ca in advance of the RSO internal deadline. For more information, please visit the KE team webpage.

Support for Research Data Management:

For information on research data management plans, processes, or best practices for your research program, please contact research.data@libanswers.ucalgary.com and/or visit https://libguides.ucalgary.ca/researchdatamanagement.

Support for EDI in Research:

RSO can provide resources and support to research teams on the integration of equitable and inclusive practices in research design and research practice. Contact Erin.OToole@ucalgary.ca for more information.

RMS: Creating a Pre-Award LOI

RMS: Creating a Pre-Award Application