Investigator—Initiated Clinical Trial Administrative Extension SOP

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

Some links will work for NIAID staff only.

Purpose

To provide funds for the completion or orderly termination of investigator-initiated clinical trials when a delay occurs due to circumstances the principal investigator (PI) could not foresee or control, the PI has adequately addressed reasons for the delay, and the clinical trial remains high priority for NIAID.

Procedure

NIAID extends investigator-initiated clinical trials through a noncompetitive process that provides funds to investigators when their clinical trial is delayed because of unanticipated or uncontrollable circumstances. Find details in the January 30, 2007 Guide notice.

After a PI adequately explains the reasons for the delay and solves any problems, NIAID may extend a clinical trial if it remains a high priority and based on availability of funds.

A PI may be a candidate for an administrative noncompetitive extension when a clinical trial is delayed for any of the following reasons:

  • Difficulties obtaining suitable study agent
  • Difficulties meeting enrollment schedule
  • Difficulties obtaining assurances and certifications
  • Difficulties with access to suitable facilities
  • External holdups at regulatory or funding agencies (not related to safety)
  • Litigation involving any of the above
  • Changes in public health policy or standards of care

NIAID does not issue administrative extensions for clinical trials delayed due to safety concerns, persistent systemic problems, suspended grant activities, or natural disasters. For the latter, go to NIH Extramural Response to Natural Disasters and Other Emergencies.

If a delay is due to vandalism or another isolated event unrelated to the trial, the PI should contact the program officer or grants management specialist.

Principal Investigators

  • At least 18 months before a clinical trial grant ends, contact the Program Division Contact listed below to discuss the following:
    • Status of your clinical trial
    • Reason for the delay
    • Assurance that all problems have been addressed
    • Estimated time and funds needed to complete the study
  • NIAID program staff will determine if you are a candidate for an administrative extension and invite you to submit an application if your candidacy is approved.
  • After you receive an invitation, submit an abbreviated PHS 398 paper application, progress reports, all data and safety monitoring board reports, and other related documentation to NIAID, including the invitation.
  • Read the PHS 398 application instructions. Your application should contain only the pages and information listed in the January 30, 2007 Guide notice.
  • Submit an application at least 90 days before an upcoming advisory Council meeting. NIAID conducts an internal programmatic evaluation of the application.
  • Administrative extensions do not undergo peer review; do not send your application to the NIH Center for Scientific Review (CSR) or submit electronically. Send a PDF with original signature to the Grants Management Contact listed below.
  • NIAID program division staff will notify you in writing when the application is received, when NIAID will review the application, and the soonest possible award date.

Program Officers

Program Division Contacts

Grants Management Staff

Council

  • Discuss type 4s, not review them en bloc.
  • Make a funding recommendation.

Contacts

Applicants with questions should contact the appropriate person listed below.

Program Division Contacts

DAIDS—Martin Gutierrez

DAIT—Ellen Goldmuntz

DMID—NIAID_DMID_IICT@niaid.nih.gov

Grants Management Contacts

DAIDS—Robert Kirker

DAIT—Tamia Carter

DMID—Dhana Khurana and Sam Ashe

SBIR/STTR—Robert Kirker and Tamia Carter

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

Investigator-Initiated Clinical Trial Administrative Extensions Questions and Answers

Investigator-Initiated Clinical Trial Resources

Human Subjects Research Requirements in Grants SOP and other Human Subjects SOPs​

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