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Investigator-Initiated Clinical Trial Planning and Implementation Awards

Lock icon: This link will not work for public visitors.Some links will work for NIAID staff only.

Standard Operating Procedure Table of Contents

Purpose

To support investigator-initiated clinical trials through planning grants (R34), implementation grants (R01), or implementation cooperative agreements (U01) through a defined policy and process.

Procedure

To apply for an award to support an investigator-initiated clinical trial, applicants must go through the following process.

Applicants apply for one of these three awards:

All three application types will benefit from prior consultation with program staff, as described below. For NIAID's definition of high and non-high risk, see R01 Process for Applicants and PIs and U01 Process for Applicants and PIs below.

 

Prior Consultation for R34, R01, or U01—All Applicants and PIs

You are strongly encouraged to request a prior consultation with NIAID staff at least 10 weeks before the application due date.

The program officer will give you a letter signed by the NIAID division director that summarizes the prior consultation discussion. Attach the letter as a PDF file in the PHS 398 Cover Letter File of your grant application package. Include the name of the program officer who handled your request.

The time frames listed below are minimums; start the process as soon as possible. See the Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications.

Initial Inquiry and Discussion With NIAID

Requesting Prior Consultation

  • Within two weeks of your initial discussion (a minimum of eight weeks before the receipt date):
  • If your R01 or U01 application requests a budget over $500,000 in direct costs in any year, include a section requesting approval for a big grant application. We will handle the budget approval and prior consultation requests simultaneously.
  • The program officer will send your prior consultation request through an internal NIAID process.
  • Within six weeks of NIAID's receipt of your prior consultation request, you will receive a letter signed by the relevant division director or designee summarizing the internal discussion.
  • Attach a PDF of the prior consultation summary letter in the PHS 398 Cover Letter File of the grant application package. Include the name of the program officer who handled your request.

R34 Process for Applicants and PIs

Consulting and Applying

R01 Process for Applicants and PIs

Consulting

  • You are strongly encouraged to consult with a program officer before applying, as described above at Prior Consultation for R34, R01, or U01.
  • Apply for a milestone-driven R01 if the clinical trial you propose is non-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.
  • Note: If for other reasons we determine that substantial staff involvement is necessary, we may ask you to apply for an implementation cooperative agreement (U01). See U01 Process—Applicants and PIs below.
  • To be ready to apply, the following documentation must be ready when you request NIAID prior consultation:
    • Complete clinical protocol
    • Informed consent and, if applicable, assent forms
    • Statistical analysis plan
    • 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
Applying

Post-Implementation Award

U01 Process for Applicants and PIs

Consulting
  • You are strongly encouraged to consult with a program officer before applying, as described above at Prior Consultation for R34, R01, or U01.
  • Apply for a U01 if the clinical trial you propose is high-risk, which we define as follows:
    • You plan to provide a non-routine intervention, i.e., an intervention that would not otherwise be provided for the study condition in the facility where the trial is being conducted.
    • You plan to administer an unlicensed product or use a licensed product for an unapproved indication.
  • To be ready to apply, the following documentation must be ready when you request NIAID prior consultation:
    • 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 cofunding, if applicable and necessary for completing the trial
    • Plan for submitting regulatory documents to appropriate regulatory authorities, for example, IND and IRB 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
Applying Post-Implementation Award

Program Staff and Management

Initial Inquiry and Discussion With NIAID

Prior Consultation Process for R34

  • Applicants should send a formal written request for prior consultation to the program officer at least 10 weeks before a receipt date.
  • The program officer completes Sections A, F, G, and remaining parts of B on the Lock icon: This link will not work for public visitors.Request Form for Prior Consultation for an Investigator-Initiated Clinical Trial Application and emails it to the division director.
  • The division director completes Section D of the form.
  • After the prior consultation discussion is complete, a program staff member prepares a letter for the division director's signature.
  • The program officer sends the applicant the signed letter that summarizes the prior consultation discussion.

Prior Consultation Process for R01 and U01

  • Applicants should request prior consultation from the program officer at least 10 weeks before the receipt date.
  • The program officer completes Sections A, C, F, G, and relevant parts of B on the Lock icon: This link will not work for public visitors.Request Form for Prior Consultation for an Investigator-Initiated Clinical Trial Application and emails it to the division director.
  • After consulting with the Budget and Financial Management Branch, the division director has the authority to accept or reject any request up to $1 million in direct costs for any year.
  • If the request is for more than $1 million in direct costs for any year, the application also goes to the U01 Review Committee, who will present a recommendation to all the division directors. Complete Section E.
  • Program staff prepare a letter that summarizes the prior consultation discussion for their division director's signature. The letter should also include approval for a big grant if the budget includes total direct costs of $500,000 or more in any year.
  • The program officer sends the applicant the signed letter that summarizes the prior consultation discussion. The program officer also sends a copy to the division director, DEA contact (see below), and appropriate division coordinator (see below).

Contacts

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

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Last Updated April 01, 2013

Last Reviewed March 29, 2013