Clinical Research Toolbox
Do you have a great concept for a research project? With a bit of advanced planning, our toolbox can help you take a great idea, and make it reality.
How the CTN+ can help
Planning can help prevent challenges and delays. Dedicate significant time to designing and project managing your study: clearly articulate your objectives, hypothesis, and how you will meet these objectives. Seeking expert advice on the activities listed will prevent your project from facing costly delays. Consider connecting with the relevant Regional and Think Tank personnel to seek expert advice.
Only CTN+ Researchers, their staff, Regional and Think Tank personnel, and CTN+ Postdoctoral Fellows can access CTN+’s research services. You can find more information about joining the CTN+ here.
Project Development
The next four sections apply to anyone developing a clinical research project. The CTN+ provides support services to our researchers to help make their research a reality.
A proper literature search is integral to defining your research question and designing your study. Here are a few examples of available resources that can help. Check with your own institution for specific services offered.
If your research question is too broad, you will have difficulty designing a focused study to answer your hypothesis. If it’s too narrow, you will have difficulty finding appropriate participants.
Engaging your research population during grant or project development is now required by most funders. Refining your idea with the community will give you a pragmatic view on the applicability and feasibility of your research. Engaging with the CTN community-centered Knowledge Mobilization Hub helps researchers successfully engage with community members.
Seek experts who will provide you with advice and review your proposal. Find out if your institution will assist with project/grant development.
CIHR is the primary source of federal funds for health research in Canada.
Other suggestions for funding are:
- Provincial and institutional funding competitions
- Disease-related foundations (e.g. CANFAR, Heart and Stroke Foundation)
- Industry partners. A pharmaceutical or medical device company may provide direct funding for a project via their established investigator-initiated study funding mechanism, or they may consider donating the study intervention (e.g. drug or device)
- Hospital Foundations
CTN+ Review Phase
This information is for Portfolio studies only.
The CTN+ Portfolio Study Submission process occurs three times per year and is open to CTN+ Researchers who are in the process of seeking a primary source of funding for their project.
For any competition that requires a CTN+ Letter of Support, the CTN+ must be contacted 8 weeks prior to the application deadline via the online system Apply. The CTN+ Letter of Support will be provided approximately a week before the application deadline.
The documents submitted to the CTN+ undergo peer review by the Scientific Review Committee (SRC), if required and not previously peer-reviewed, and the Community Advisory Committee (CAC). All committee members are bound by confidentiality agreements. Information about the review committees may be found in our Committees section.
Project Setup
Depending on the complexity, an estimated timeline for project set-up is 6 to 12 months. Health Canada applications, ethics, contract review, and administrative approvals can often be simultaneous.
While you can use your proposal as a template for your protocol, a proposal is written to only obtain support for your study. A study protocol contains detailed instructions on how the study will be conducted and includes information to meet regulatory requirements (if applicable). Advancing Health provides protocol templates for use in interventional and non-interventional clinical studies.
To help strengthen grant applications related to the CTN+ Scientific Priorities, eight weeks before a grant is due, CTN+ Researchers, completing the Letter of Support process can request brief consultations from the CTN+ for the following: methodology, community, knowledge mobilization, Indigenous Guidance Council, and a Health Canada regulatory consultation (as required).
CTN+ Research services
To help strengthen grant applications related to the CTN+ Scientific Priorities, eight weeks before a grant is due, CTN+ Researchers, completing the Letter of Support process can request brief consultations from the CTN+ for the following: methodology, community, knowledge mobilization, Indigenous Guidance Council, and a Health Canada regulatory consultation (as required). These consultations will be scheduled after the applicant begins the LoS process using Apply.
If the CTN+ Researcher will require the services listed in the Cost Recovery section of the CTN+ services list, CTN+ staff will help source the resources within the CTN+ region and provide the researcher with an estimate for their grant application budget. If the grant is successful, the Region/institution providing these services will cost-recover their work from the grant.
For more information, contact echerban@hivnet.ubc.ca.
Before starting any type of research study, you must obtain approval from your local ethics committee, obtain organizational/institutional approval, and fully execute any required contracts or agreements. This includes finalizing the agreement between your institution and the CTN+.
Successful applicants are required to complete all the necessary requirements for their home institution including:
- Establishing a grant account per the requirements of their home institution, oversee (if applicable) spending for the study, and provide the CTN National Centre with financial statements as required
- Fulfilling their institutional Research Ethics Board requirements
- Observing the progress of contract negotiation between their home institution and the CTN National Centre and responding to their home institution promptly
If your study is testing a new drug, or an approved drug outside of its approved use, then you will have to submit a Clinical Trial Application (CTA) to Health Canada
All Health Canada-regulated clinical trials require maintenance of essential documents. Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, recording, analyzing, and reporting of research that involves human participants.
Project Execution
Is your study ready to get up and running? From management to monitoring, here are the steps you’ll need to take.
If approved, the CTN+ provides support in clinical trial/project management and monitoring.
After you have completed data collection, and ensured the data is clean and complete, you can begin your data analyses following the study Statistical Analysis Plan. This will likely involve programming data summaries, tables, and plots for abstracts, presentation or manuscripts.
Once you have completed an interim or preliminary analysis, it’s a good idea to review your KM plan to decide if any changes are needs to your tactics and timelines.
The CTN+ Knowledge Mobilization Hub shares plain language results via website, social media, e-newsletter, and community outreach. The Hub also assists CTN+-supported study teams in designing, executing, and evaluating KM strategies to improve the impact of their work.
To help the Hub promote your work, follow the CTN+ Publication Guidelines acknowledge CTN+ support on papers, posters, and presentations and inform the CTN+ of any publications and presentations resulting from your CTN+-supported studies
For clinical trials regulated by Health Canada, you are required to retain study documents for 15 years after trial completion. If your study is not a regulated clinical trial, you should retain your records per institutional requirements. Don’t forget to close the study with your local Ethics Board, and with any funding agencies.
Download a Close-out Visit Report and a Close-out Letter.
Further Information:
Network of Networks
Health Canada Clinical Trials
Common clinical research terminology
Our People
CTN+ Researchers are the backbone of the Network through generating ideas, collaborating on new initiatives, conducting research, and sharing their knowledge.
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