cihr-grant-writing

name: cihr-grant-writing description: Section-by-section guide for writing CIHR Project Grant applications, covering RCTs, AI/technology, observational studies, with scoring rubrics and templates. Use when drafting, reviewing, or scoring a CIHR grant application.

CIHR Grant Writing Skill

Overview

A section-by-section guide for writing CIHR Project Grant applications, modeled on the structure of the PANTHEON SLIM (Randomized Controlled Trial) grant and cross-referenced with the CardioAgent (AI/Technology) grant. This skill is generalizable across clinical trials, observational studies, AI/technology development, and other health research study designs.

Each section includes: Requirements (what must be present), Expectations (what reviewers look for), Scoring Rubric (weighted scoring criteria), and Templates (fill-in-the-blank scaffolds).

For CIHR-specific language tips, study type adaptations, and common reviewer critiques, see the appendices.

SECTION 1: The Need for a Trial / Study

Weight: 25/100

This section must build the case that your study addresses a critical, unmet need. It follows a hierarchical argument structure.

1.1 What is the problem to be addressed?

Weight: 5/25

Requirements

• State the clinical/scientific problem in 2-3 sentences maximum
• Define the specific patient population or target group
• Identify what is currently unknown or what practice gap exists
• State why current evidence is insufficient (e.g., "no RCT has addressed...", "current AI tools lack...")
• Use underline/bold formatting to emphasize the key population and the key gap

Expectations

• The problem statement should be immediately understandable to a non-specialist reviewer
• Frame as a patient-centered or health-system problem, not just a scientific curiosity
• Quantify the problem where possible (mortality rates, error rates, prevalence)
• Explicitly state the knowledge gap that this study will fill

Template

The problem to be addressed is that [specific clinical/scientific gap] in [target population] is unknown/unresolved. [Current approach or standard of care] represents [limitation], but [it has only been studied in X / no evidence supports Y / current tools cannot Z]. [Quantify the consequence of not addressing this gap].

Scoring Rubric

1.2 What are the principal research questions to be addressed?

Weight: 5/25

Requirements

• State the overarching objective in one sentence (use the study acronym if applicable)
• State the central hypothesis clearly
• Define the primary objective with a feasibility/success threshold (for pilot) or primary endpoint (for phase III)
• List secondary objectives (numbered, 2-4 items)
• List exploratory objectives (numbered, 2-5 items)
• For each objective level (primary/secondary/exploratory), state whether results will be evaluated by sex and gender subgroups
• For pilot/feasibility studies: primary objective MUST be operational (e.g., recruitment rate), not clinical

Expectations

• Objectives must follow a clear hierarchy: Primary > Secondary > Exploratory
• The primary objective must be answerable with the proposed design and sample size
• For pilot studies: clinical outcomes are exploratory only (state this explicitly)
• Sex and gender analysis commitment should be present at every objective level
• Use CIHR-specific language: "patient-oriented," "sex and gender-based analysis (SGBA+)"

Template

Overarching objective: The overarching objective of the "[STUDY ACRONYM]" [study type] is to [determine/evaluate/develop] [intervention/technology] [in what population] [to achieve what].

Central hypothesis: We hypothesize that [intervention/approach] will [expected effect] compared with [comparator] in [population].

Primary objective: To [specific measurable objective]. Success threshold: [define].

Secondary objectives: i. To [objective 1]; ii. To [objective 2].

Exploratory objectives: i. To [objective 1]; ii. To [objective 2]; iii. To [objective 3].

Scoring Rubric

1.3 Why is a trial/study needed now?

Weight: 10/25

This is the most critical subsection of the entire "Need" section. It builds the scientific rationale through a logical chain of evidence. Use numbered subsections (1.3.1, 1.3.2, etc.).

Requirements

• 1.3.1 Burden of disease/problem: Canadian and global epidemiological data with citations
• 1.3.2 Current standard of care/approach: What is currently done and why it works (partially)
• 1.3.3 Limitations of current approach: Why the standard of care is insufficient (quantify risks, error rates, costs)
• 1.3.4 Emerging evidence for the proposed approach: What new evidence suggests a better strategy exists
• 1.3.5 Evidence gap in the target population: Demonstrate that the proposed approach has NOT been studied in your specific population (cite systematic review or guideline gap)
• 1.3.6 Specific technical/clinical gap: Address any unique safety or feasibility concerns
• 1.3.7 Sex and gender representation gap: Demonstrate that prior studies lacked adequate sex/gender representation and analysis
• Use bold/underline for the key concluding statement of the evidence gap
• Include at least one citation from your own team's prior work in this field

Expectations

• Build the argument like a legal brief: each subsection leads logically to the next
• Use Canadian data prominently (CIHR is a Canadian funder) or primarily
• Demonstrate clinical equipoise with real-world data (e.g., practice variation showing disagreement)
• The final statement should be a bold, underlined, definitive assertion of the knowledge gap
• Reference your own prior work to show you are the right team to address this gap
• For AI/technology studies: address current limitations of existing AI approaches and why yours is different

Template for Key Concluding Statement

There is thus an important knowledge gap to support the use of [proposed approach] in [target population], despite the fact that this population represents [quantify the size/importance of the population].

Scoring Rubric

1.4 How will the results of this trial/study be used?

Weight: 3/25

Requirements

• For pilot studies: state that results will inform the design of a phase III confirmatory study
• For confirmatory studies: state that results will influence clinical guidelines
• Describe the dissemination plan: conferences, journals, social media, public engagement
• State whether the study could transition to the next phase seamlessly (adaptive design)
• Explain why CIHR funding is required (e.g., no industry interest due to generic drugs / public health focus)
• Name the specific guideline body or clinical practice that would be impacted

Scoring Rubric

1.5 Are there any risks to the safety of participants?

Weight: 2/25

Requirements

• State the risk profile of the intervention explicitly
• For de-escalation studies: emphasize that no NEW risks are expected
• For technology studies: address privacy, data security, and potential for misdiagnosis
• Acknowledge theoretical risks and cite evidence that these have NOT been observed in comparable populations
• Describe monitoring mechanisms (DSMB, adverse event reporting)

Scoring Rubric

SECTION 2: The Proposed Trial / Study Design

Weight: 40/100

This section covers all methodological details. Each subsection maps to a specific CIHR review criterion.

2.1 What is the proposed trial/study design?

Weight: 5/40

Requirements

• State the study design using standard terminology (e.g., "pilot, multi-center, double-blinded, pragmatic, patient-centered RCT")
• State whether it is a pilot/feasibility study or a confirmatory study
• If pragmatic: reference PRECIS-2 tool and justify pragmatic elements
• Describe patient engagement strategy: patient partners on steering committee, co-development of protocol
• For AI/technology: describe the validation framework (retrospective + prospective phases)
• Include a study flowchart figure

Template

The proposed [study] is a [phase], [number of sites]-center, [blinding], [pragmatic/explanatory], and [patient-centered] [study type] designed to [primary purpose]. [Population] will be eligible. [Brief description of randomization/allocation]. The [pragmatic/explanatory] design ensures that [justification].

Scoring Rubric

2.2 What are the planned trial interventions?

Weight: 4/40

Requirements

• Describe the experimental intervention with dose/frequency/route/duration
• Describe the control intervention with the same level of detail
• Justify the choice of comparator with evidence and guideline references
• Address regulatory requirements (e.g., Health Canada Clinical Trial Application)
• Describe management of participants on prior therapies (switching protocols)
• State that all other treatments follow standard of care (pragmatic principle)
• Describe post-study care plan

Scoring Rubric

2.3 Allocation to trial groups

Weight: 2/40

Requirements

• State allocation ratio (e.g., 1:1)
• State stratification variables with justification (cite validation of stratification tool)
• State block sizes
• Name the randomization platform/system
• For non-RCT designs: describe sampling or allocation strategy

Scoring Rubric

2.4 Methods for protecting against sources of bias

Weight: 2/40

Requirements

• Describe blinding strategy (who is blinded: participants, investigators, outcome assessors)
• Describe allocation concealment method
• For AI studies: describe blinding of human evaluators to AI outputs
• Address potential sources of bias specific to your design

Scoring Rubric

2.5 Inclusion/exclusion criteria

Weight: 3/40

Requirements

• List inclusion criteria as bullet points
• List exclusion criteria as bullet points
• For pragmatic trials: explicitly state that few exclusion criteria are used to maximize generalizability
• Justify any exclusion criterion that removes a specific subpopulation
• Describe screening log data collection: baseline characteristics, sex, gender, race, ethnicity, reasons for exclusion
• Address EDI: describe strategies to include underrepresented populations (e.g., Indigenous communities)
• For heterogeneous populations: acknowledge heterogeneity and state how subgroups will be characterized

Scoring Rubric

2.6-2.7 Treatment duration and follow-up

Weight: 2/40

Requirements

• State treatment duration with start and end points
• State follow-up visit schedule with specific time points
• State visit modalities (in-person, telephone, video)
• State total study duration (recruitment + follow-up)
• State recruitment period duration

Scoring Rubric

2.8 Primary and secondary outcome measures

Weight: 6/40

Requirements

• Primary outcome: State with exact definition, measurement method, and success threshold
• Secondary outcomes: List each with definition (numbered, 2-5 items)
• Exploratory outcomes: List each with definition (numbered, 3-6 items)
• For pilot studies: primary outcome MUST be feasibility-related (recruitment rate, adherence, etc.)
• For clinical trials: use standardized endpoint definitions (e.g., Academic Research Consortium, BARC bleeding)
• For AI studies: define accuracy metrics (AUROC, F1, sensitivity, specificity) and reference standards
• Include patient-oriented outcomes
• For novel endpoints: describe the development methodology (e.g., discrete-choice experiment)

Scoring Rubric

2.9 How will outcomes be measured at follow-up?

Weight: 2/40

Requirements

• State the data source for each outcome category (screening logs, medical charts, self-report, imaging)
• State whether endpoints will be adjudicated (and by whom) or not adjudicated (justify for pilot)
• Describe adverse event and serious adverse event monitoring
• For AI studies: describe the reference standard / ground truth generation process (e.g., central reader model)

Scoring Rubric

2.10 Sample size justification

Weight: 4/40

Requirements

• For pilot/feasibility studies: state explicitly that formal sample size calculation is not applicable; provide expected enrollment range based on recruitment assumptions
• For confirmatory studies: provide full power calculation with alpha, beta, effect size, and assumptions
• State the basis for effect size assumptions (prior studies, pilot data, clinical significance)
• Address multiple comparisons if applicable
• For AI studies: justify the number of cases for training/validation/testing; describe stratified sampling for rare conditions

Scoring Rubric

2.11-2.14 Practical considerations

Weight: 4/40

Covers: health service research issues, recruitment, compliance, and loss to follow-up.

Requirements

• Recruitment: State expected rate per site per month with evidence; describe recruitment process; state total expected enrollment
• Compliance: Describe adherence monitoring strategy; cite expected adherence/discontinuation rates from prior trials; describe patient-partner involvement in adherence strategies
• Loss to follow-up: State expected rate with evidence; describe retention strategies; commit to identifying barriers
• For all three: state that sex/gender disparities will be monitored and mitigated

Scoring Rubric

2.15 Number of centers

Weight: 1/40

Requirements

• List all centers with site PI name and role
• Include geographic diversity (for Canadian multi-center: multiple provinces)
• Reference letters of support from each site
• For international sites: describe regulatory coordination plan

2.16-2.18 Analysis plan

Weight: 5/40

Requirements

• Type of analyses: For pilot: explicitly state "most analyses will be descriptive"; for confirmatory: state primary statistical test
• Describe analysis for each outcome level (primary, secondary, exploratory)
• State whether intention-to-treat or per-protocol analysis (or both)
• Frequency of analyses: State whether interim analyses are planned; describe DSMB access to data
• Subgroup analyses: List pre-specified subgroups (sex, gender, site, risk score); state whether interaction testing will be performed
• For AI studies: describe performance metrics, calibration, and fairness analyses across demographic subgroups

Scoring Rubric

2.19 Prior pilot work / Preliminary data

Weight: 2/40

Requirements

• Describe all preliminary studies that inform this proposal (surveys, observational studies, pilot data)
• For each: state IRB status, funding source, and how results will inform the current study
• Demonstrate that these studies were conducted independently (no overlapping funds)
• For AI studies: present preliminary performance data in table format (model comparison)
• State how the totality of the preliminary program will inform the proposed study

Scoring Rubric

SECTION 3: Trial / Study Management

Weight: 15/100

3.1 Day-to-day management arrangements

Weight: 5/15

Requirements

• Name the coordinating center / academic research organization (with experience record)
• Describe: contract management, site coordination, electronic case report forms, database management, data governance, medical monitoring, regulatory submissions, statistical analysis, DSMB coordination
• Describe monitoring plan (in-person vs. remote; frequency)
• Describe data security: source document storage, de-identification, platform name
• For AI studies: describe data pipeline, model deployment infrastructure, and privacy architecture (on-premises, VPC)

Scoring Rubric

3.2 Role of each principal applicant and co-applicant

Weight: 5/15

Requirements

• For each team member: Name, degree, role (NPA/PA/Co-A), career stage, institution, specific contribution
• Nominated Principal Applicant: must be "ultimately responsible for all aspects"
• Describe the executive committee composition
• Show complementary expertise across team (clinical, methodological, statistical, patient engagement, regulatory, EDI)
• For multi-center: identify site PIs
• Reference letters of support

Scoring Rubric

3.3 Steering committee and DSMB

Weight: 5/15

Requirements

NOTE: This may be optional depending on the study type.

• Steering committee: List composition (executive committee + site PIs + patient partner)
• DSMB: State coordinating body; meeting frequency; charter development; composition (clinician chair + statistician minimum)
• For pilot studies: state that DSMB will NOT terminate for efficacy/futility but MAY terminate for safety
• For confirmatory studies: define stopping rules (efficacy, futility, safety)

Scoring Rubric

SECTION 4: General Considerations (Cross-Cutting Themes)

Weight: 10/100

These themes must be woven throughout the proposal but are often evaluated as a standalone criterion.

4.1 Sex, Gender, and Equity (SGBA+)

Weight: 4/10

Requirements

• Define how sex and gender will be collected (female/male/other for sex; woman/man/X gender/other for gender)
• Commit to sex- and gender-stratified analyses at each objective level
• Collect gender-specific and sex-specific non-traditional risk factors
• Address historical under-representation of women/gender minorities in your field
• Describe mitigation strategies if disparities are observed
• For AI studies: describe fairness monitoring across demographic subgroups (demographic parity, equalized odds)
• State sampling strategies to achieve sex balance (e.g., "approximately 50% women")

4.2 Patient Engagement

Weight: 3/10

Requirements

• Name the patient partner(s) on the steering committee
• Describe their specific contributions (protocol co-development, recruitment strategies, adherence strategies, knowledge mobilization)
• Reference EDI framework used (e.g., CEPPP Learning Together Evaluation Framework)
• Describe patient-oriented outcome development (if applicable)
• Include letter of collaboration from patient engagement center

4.3 Knowledge Translation and Dissemination

Weight: 3/10

Requirements

• Describe publication plan: target journal tier, conference presentations
• Describe public engagement: social media, mainstream media, patient communities
• For AI studies: describe open-source release plans and platform accessibility
• State how results will be incorporated into clinical guidelines (name the guideline body)
• Describe regulatory pathway if applicable (Health Canada SaMD, Clinical Trial Application)

Overall Scoring Summary

Score Interpretation

• 90-100: Fundable as-is. Minor revisions only.
• 75-89: Competitive. Address reviewer concerns in specific sections.
• 60-74: Needs significant revision. Major gaps in 1-2 sections.
• Below 60: Fundamental redesign needed.