Requesting Prior Consultation to Discuss Submission of a Clinical Trial Planning (R34) or Implementation (R01 or U01) Application

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

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, see the Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications.

For general information on investigator-Initiated clinical trial planning (R34) and implementation (R01 or U01) awards, 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 the Institute.
• R01—you are ready to implement a clinical trial that is not high risk.
• U01—you are ready to implement a clinical trial that is high risk.

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 you would have prepared during an R34 clinical trial planning grant.

See the lists of documentation to prepare for the prior consultation in the R01 and U01 sections of the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.

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

Apply for an investigator-initiated clinical trial implementation R01 if you propose a clinical trial that is not high risk, which we define as follows:

• You plan to provide a routine intervention, i.e., an intervention that would normally be provided for the study condition in the facility where the trial is being conducted.
• You plan to administer a licensed product for an approved indication.

If either of these circumstances is the not case, your trial is high risk, and you must apply for a clinical trial implementation U01.

(NIAID may determine that substantial staff involvement is necessary for other reasons and ask you to apply for a U01.)

4. Prepare Ahead for Your Discussion With a Program Officer

Before contacting a program officer, do the following:

• Think through all items listed in the section below that you will identify and discuss with the program officer.
• Then at least 10 weeks before the receipt date, call or write the appropriate NIAID program officer, who will discuss these items with you in detail. Find contact information in the program announcements:
  • NIAID Clinical Trial Planning Grant (R34)
  • NIAID Clinical Trial Implementation Grant (R01)
  • NIAID Clinical Trial Implementation Cooperative Agreement (U01)

5. Request Prior Consultation

After you have a prior consultation with NIAID program staff for an R34, R01, or U01 application, submit the following to the NIAID program officer in five pages or less:

• 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) including, if applicable, justification for a budget greater than $500,000. See the Big Grant Applications section below.
• Proposed start date, duration, and timeline of the clinical trial

Big Grant Applications

• If you are requesting a budget over $500,000 in direct costs in any one year, include a section for approval of a big grant application in your request for prior consultation.
• Read the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP for details.

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