U01 Investigator-Initiated Clinical Trial Award 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 high-risk investigator-initiated clinical trials (IICTs) and mechanistic studies associated with high-risk clinical trials.

Procedure

U01 IICT implementation grants are reserved for high-risk projects that require substantial staff involvement. Refer to NIAID’s Criteria for High-Risk Clinical Trials.

NIAID accepts new, renewal, resubmission, and revision applications.

Implementation refers to activities related to the conduct, completion, and analysis of the clinical trial, such as:

  • Training of study personnel.
  • Enrollment and recruitment of study subjects.
  • Data collection, management, and quality control.
  • Laboratory work and data analyses.
  • Study management and oversight.
  • Establishment of committees to manage the complexity of the trial.
  • Preparation of the final study report.
  • Regulatory activities and site monitoring.
  • Other related post-enrollment activities.
  • Mechanistic studies, as applicable.

U01 clinical trial implementation grants do not support planning activities for a clinical trial, such as development of study design, clinical protocol, milestone plans, research teams, or informed consent or assent documents. For those activities, principal investigators (PIs) may consider applying for an NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed).

NIAID Clinical Terms of Award will be part of the terms and conditions of award. Check the NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) program announcement for additional terms and conditions of award, which will be modified for each cooperative agreement.

If the trial requires an investigational device exemption (IDE) or investigational new drug (IND), NIAID will decide who will hold it. PIs can discuss options with the appropriate NIAID program staff.

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

Milestones will be incorporated into your terms of award. NIAID will consider the successful attainment of milestones as part of its ongoing assessment of progress. NIAID may periodically review the progress of the clinical trial.

Applicants and Principal Investigators

Before Applying

Applying

  • Follow instructions in the NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) notice of funding opportunity.
  • Include your prior consultation letter as an Other Attachment. You will receive this letter by email after your consultation. The letter will summarize the discussion.
  • 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 necessary to successfully implement the proposed clinical trial.
    • Support services include but are not limited to regulatory submission, clinical site monitoring, safety monitoring, and quality management.
    • 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.

After Award

Program Staff and Management

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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