Requesting Prior Consultation—Clinical Trial Applications and Planning Grants

Related SOP: Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP

Use this document to:

  1. Determine the appropriate award type based on your readiness to undertake a clinical trial and risk to subjects.
  2. Prepare ahead for your discussion with an NIAID program officer.
  3. Prepare your formal request for prior consultation to discuss submission of a clinical trial application.

For timing of your prior consultation request, refer to the Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications.

To confirm your research meets NIH’s definition of a clinical trial, use NIH’s Decision Tool.

For general information, go to Investigator-Initiated Clinical Trial Resources.

1. Consider Award Type

Consider which award type may be appropriate.

  • R34—you need a planning period funded by NIAID.
  • R01—for investigators who are ready to begin a clinical trial that is not high-risk.
  • Extended R01—for investigators who are ready to begin a 6- or 7-year clinical trial that is not high-risk.
  • R21—for investigators who are ready to begin a clinical trial that is not high-risk.
  • U01—for investigators who are ready to begin a high-risk clinical trial.
  • U44—for small businesses who are ready to begin a clinical trial.

Go to the next steps to determine readiness and risk.

2. Assess Readiness to Implement a Clinical Trial

To be ready to undertake a clinical trial, you must have ready all documentation NIAID requires. Refer to the relevant notice of funding opportunity (NOFO) from the list of award types above.

If you are not ready to implement a clinical trial, go to step 4 to request prior consultation from NIAID for an R34 clinical trial planning grant.

3. Assess Research Risk

Choose which award type to apply for based on level of risk. The NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) supports high-risk clinical trials as described in the NOFO.

For the NIAID definition of high-risk, refer to Criteria for High-Risk Clinical Trials.

For studies that are not high-risk, applicants may apply for the NIH Research Project Grant (Parent R01, Clinical Trial Required) or an NIH Exploratory/Developmental Research Project Grant (Parent R21, Clinical Trial Required).

The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required) award encourages high-risk clinical studies, though applicants may also propose studies that are not considered high-risk.

NIAID may determine that substantial staff involvement is necessary for other reasons and ask you to apply for a U01 or convert your award to a U01 after award.

4. Prepare Ahead for Your Discussion with a Program Officer

Before contacting a program officer, read the relevant NOFO for a list of documents you need to have ready to discuss with your NIAID program officer.

Think through all items listed below in steps 5 and 6 and gather all the information you don’t already have.

5. Request Prior Consultation

As shown on Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications, at least 10 weeks (12 weeks for an extended trial or applications with budget requests at or larger than $1,000,000 in direct costs in any year) before the receipt date, call or write the appropriate NIAID program officer. Find contact information in the NOFOs listed above in step 1.

You and the program officer will have a detailed discussion about the information listed.

Your program officer will ask for some information before the discussion. While this may vary from one call to the next, R01, U01, and U44 requests always cover specific items. Prepare to share the following items with your program officer:

For an R01 application

  • Protocol synopsis.
  • Informed consent and, if applicable, assent forms.
  • Statistical analysis plan.
  • Listing that includes identification and qualifications of clinical trial sites, pharmacies, and laboratories.
  • Comprehensive laboratory plan.
  • Clinical data management plan (separate from the Data Management and Sharing Plan).

For a U01 or U44 application

  • Complete clinical protocol.
  • Informed consent and, if applicable, assent forms.
  • Statistical analysis plan.
  • Plan for acquiring and administering study agents.
  • Investigator’s Brochure or equivalent for study products.
  • Documentation of adequate co-funding, if applicable and necessary for completing the trial.
  • Plan for submitting regulatory documents to appropriate regulatory authorities, for example, investigational new drug and Institutional Review Board submissions.
  • Listing that includes identification and qualifications of clinical trial sites, pharmacies, and laboratories.
  • Table of Contents for the Manual of Operations.
  • Comprehensive laboratory plan.
  • Data management plan.
  • Site quality management plan.

Note, these lists do not include everything you might discuss. They are the minimum you should expect to share.

6. Follow Up After Prior Consultation

After you have a prior consultation with NIAID program staff, submit the following to the NIAID program officer in five pages or less:

  • Study title.
  • Study principal investigator.
  • 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) including, if applicable, justification for a budget of $500,000 or more. Refer to the Big Grant Applications section below.
  • Proposed start date, duration, and timeline of the clinical trial.

Note for Big Grant Applications

  • If you are requesting a budget of $500,000 or more in direct costs in any 1 year, include a section for approval of a big grant application in your request for prior consultation.
  • Read the Big Grants SOP for details.

For more information, check our Investigator-Initiated Clinical Trial Resources.

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