Standardized Scoring Criteria

Scientific Merit

Score of 1 to 5

Highest = 1

Lowest = 5

• Are the hypotheses scientifically sound and answerable by the proposed design?
• Is the study appropriately designed to address the hypothesis?
• Is the population appropriate for the research? Do the eligibility criteria specify an appropriate population?
• Does the proposal include proper randomization and stratification procedures, as relevant?
• Are safety parameters specified?

Public Health Impact

Score of 1 to 5

Highest = 1

Lowest = 5

• What is the relevance of the concept to the prevention, diagnosis or treatment of infectious diseases? For example, will the resulting data prevent spread, save lives and/or decrease morbidity and if so, to what extent?
• What is the value added to the field? For example, will the study extend existing interventions or meet an unmet need?
• Does it contribute to a critical pathway that will advance science and impact public health, and if so, how?
• If shown to be effective, will the procedures or outcome described in the concept be acceptable and deliverable to key affected stakeholders (communities, clinicians, policy makers, as applicable)?

Feasibility

Score of 1 to 5

Highest = 1

Lowest = 5

• Is the proposal feasible for implementation?
• Is study product produced and available?
• Is an appropriate study population available for recruitment?
• What is the level of difficulty for study implementation?
• What is level of difficulty of meeting target accrual?
• Is there capacity to conduct laboratory assay required for the proposed endpoints in a timely and accurate fashion?
• Is the study schedule appropriate?
• Are there barriers to IRB, ethical and/or regulatory approval?

Fit with VTEU Mission

Score of 1 to 5

Highest = 1

Lowest = 5

• Is the concept aligned with the scientific priorities of the IDCRC?
• Does the proposal benefit from the VTEU model that emphasizes a multi-site, multi-disciplinary collaboration involving different populations?
• How is the proposed intervention well-suited for evaluation through the VTEU mechanism? Is this a concept that would otherwise not be evaluated through other mechanisms such as alternative/industry development pathways?

Innovation

Score of 1 to 5

Highest = 1

Lowest = 5

• Is the concept, approach, population or intervention novel?
• Will the proposed trial involve innovative methodologies or assays?

Overall Priority Score

Score of 1 to 5

Highest = 1

Lowest = 5

• Is the concept proposal of sufficient priority within the IDCRC to commit resources to the development and implementation?
• Based on the relevance of the concept proposal to the IDCRC scientific agenda, what is your level of support for the concept proposal?