| If you are considering a request for NIAID's permission to submit a Clinical Trial Planning (R34) or Implementation (U01) application, please think through these items before you call or write an NIAID program officer, who will discuss them with you in detail.
Allow enough time before your planned receipt
date to give the Institute ten weeks to determine whether it
will approve your written request to submit your R34 or U01 application.
- Study title.
- Study PI.
- Primary institution.
- Potential collaborating sites.
- Proposed geographic location or locations for the clinical trial.
- Phase of the proposed study, e.g., phase 1 or phase 2.
- Product to be evaluated and how it will be obtained.
- Industry partner, if applicable.
- Study objective or objectives.
- Proposed study population.
- Estimated sample size.
- Rationale.
- Scientific basis for and clinical significance of the proposed clinical trial.
- Potential impact on public health.
- Comparison with competitive therapies and degree of similarity with other clinical trials.
- Relevance to outcomes desired by the target patient population.
- Study design or flow diagram depicting study.
- Feasibility to successfully undertake the study.
- Brief summary of risk information, e.g., available safety data, such as the product label, for the product.
- General statistical assumptions for the proposed study design and analysis.
- Total cost estimate of the clinical trial, not the planning grant.
- Proposed start date, duration, and timeline of the clinical trial.
See NIAID's main Web page for Investigator-Initiated Clinical Trials Resources and the Human Subjects, Clinical Research section. |
