Investigator—Initiated Clinical Trial Planning and Implementation Awards SOP

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.

Some links will work for NIAID staff only.

Purpose

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

Procedure

To apply for an award to support an IICT, applicants must go through the process described below.

Our main Investigator—Initiated Clinical Trials Resources page provides an overview. Also refer to the NIAID IICT Policy Guide notice and IICT Notice of Information.

Applicants can apply for one of these awards:

  • 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

If you need support to get ready for the launch of an IICT, such as planning, designing, and preparing the documentation necessary for implementing an IICT, consider applying first for an NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed). An R34 is not a prerequisite for any clinical trial award.

Prospective IICT applicants will benefit from prior consultation with program staff, as described below.

*For the NIAID definition of high risk, check How do I determine level of risk and choose an award type for my application? on IICT Awards – General Questions and Answers.

Prior Consultation—All Applicants and Principal Investigators (PIs)

  • Request prior consultation with NIAID staff at least 10 weeks (12 weeks for an extended trial or if you plan to request a budget of $1,000,000 or larger in direct costs in any year) before the application due date.
  • If you plan to request a budget of or larger than $500,000 in direct costs in any year, include a request to submit a big grant application with your prior consultation materials. We will handle the budget approval and prior consultation requests simultaneously. Refer to the Big Grants SOP.
  • After NIAID has reviewed your materials, your program officer will give you a letter signed by the NIAID division director that summarizes the prior consultation discussion. Include this letter as Other Attachments when you apply.

Start the process as soon as possible. Refer to Prior Consultation Timeframes for Investigator—Initiated Clinical Trial Applications.

R34 Process for Applicants and PIs

Consulting and Applying

R01 and R21 Process for Applicants and PIs

Consulting

  • Consult with a program officer before applying, as described above at Prior Consultation.
  • Apply for an R01 or R21 if the clinical trial you propose is non-high risk, check How do I determine level of risk and choose an award type for my application? on IICT Awards – General Questions and Answers.
  • 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). Refer to U01 Process—Applicants and PIs below.
  • Provide the following information when you request NIAID prior consultation (you will provide more information later):
    • 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
    • Data management plan
  • Learn more in the Investigator—Initiated Clinical Trial R01 and R21 Implementation Grants Questions and Answers.

Applying

  • Follow instructions in the R01, Extended R01, or R21.
  • Include your prior consultation letter as an Other Attachment.
  • Describe all milestones in your Study Timeline. These milestones will be incorporated into your terms of award.
  • Describe in sufficient detail all the support services that would be required for successfully implementing the proposed clinical trial. This includes but is not limited to regulatory submission, clinical site monitoring, safety monitoring, and quality management. Conversely, support services do not extend to investigational new drug/investigational device exemption (IND/IDE)-enabling studies for clinical trial interventions with drugs or medical devices that the FDA has not already approved.
  • Include a sufficient and appropriate budget to support these activities. Funding depends on several factors, including technical merit, relative program priority, sufficiency of proposed budget, and available funds.

Post-Award

U01 Process for Applicants and PIs

Consulting

  • Consult with a program officer before applying, as described above at Prior Consultation.
  • 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.
  • Provide the following information when you request NIAID prior consultation (you will provide more information later):
    • 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, IND and Institutional Review Board (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
  • Learn more in the Investigator—Initiated Clinical Trial U01 Implementation Awards Questions and Answers.

Applying

  • Follow instructions in the U01.
  • Include your prior consultation letter as an Other Attachment.
  • Describe all milestones in your Study Timeline. These milestones will be incorporated into your terms of award.
  • Describe in sufficient detail all the support services that would be required for successfully implementing the proposed clinical trial. This includes but is not limited to regulatory submission, clinical site monitoring, safety monitoring, and quality management. Conversely, support services do not extend to IND/IDE-enabling studies for clinical trial interventions with drugs or medical devices that the FDA has not already approved.
  • Include a sufficient and appropriate budget to support these activities. Funding depends on several factors, including technical merit, relative program priority, sufficiency of proposed budget, and available funds.

Post-Implementation Award

U44 Process for Applicants and PIs

Consulting

  • Consult with a program officer before applying, as described above at Prior Consultation.
  • Provide the following information when you request NIAID prior consultation (you will provide more information later):
    • 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, 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
  • Learn more in the SBIR Phase II Clinical Trial U44 Implementation Cooperative Agreement Questions and Answers.

Applying

  • Follow instructions in the U44.
  • Include your prior consultation letter as an Other Attachment.
  • Describe all milestones in your Study Timeline. These milestones will be incorporated into your terms of award.
  • Describe in sufficient detail all the support services that would be required for successfully implementing the proposed clinical trial. This includes but is not limited to regulatory submission, clinical site monitoring, safety monitoring, and quality management. Conversely, support services do not extend to IND/IDE-enabling studies for clinical trial interventions with drugs or medical devices that the FDA has not already approved.
  • Include a sufficient and appropriate budget to support these activities. Funding depends on several factors, including technical merit, relative program priority, sufficiency of proposed budget, and available funds.

Post-Implementation Award

Program Staff and Management

Initial Inquiry and Discussion With NIAID

Contacts

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.

Links

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