Investigator-Initiated Clinical Trial Administrative Extensions

Purpose

To provide funds for the completion or orderly termination of investigator-initiated clinical trials when a delay occurs due to circumstances the 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 we have sufficient 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.
• You can receive up to three years of support and may request funding up to the amount in the original grant with increases of up to 3 percent a year. You may request a budget that exceeds these amounts if you provide adequate justification.
• 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 package.
• Administrative extension packages do not undergo peer review; do not send your application package to the NIH Center for Scientific Review (CSR) or submit electronically. Send an original, signed application and three signed photocopies 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

• If PIs contact you to discuss administrative extensions, refer them to the Program Division Contact listed below.
• Your division follows the steps and approval actions described in the Investigator-Initiated Clinical Trial Administrative Extension Process Table.

Program Division Contacts

• Follow the steps and approval actions described in the Investigator-Initiated Clinical Trial Administrative Extension Process Table.

Grants Management Staff

• Follow the steps and approval actions described in the Investigator-Initiated Clinical Trial Administrative Extension Process Table.
• The specialist assigned to the parent grant updates the Type 4 record in IMPAC.

Council

• Council must discuss type 4s, not review them en bloc.
• Council makes a funding recommendation.

Contacts

Applicants with questions should contact the appropriate person listed below.

Contact for General Inquiries

Anna Ramsey-Ewing, arewing@niaid.nih.gov, 301-435-8536

Program Division Contacts

DAIDS -- Martin Gutierrez, mgutierrez@niaid.nih.gov, 301-451-2703

DAIT -- Josiah Wedgwood, JWedgwood@niaid.nih.gov, 301-496-7104

DMID -- Shy Shorer, shorers@niaid.nih.gov, 301-451-3025

Grants Management Contact

Laura Eisenman
Grants Management Program
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2120, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-402-5541
Fax: 301-493-0597
Email: leisenman@niaid.nih.gov

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Links

Investigator-Initiated Clinical Trial Administrative Extensions questions and answers

Investigator-Initiated Clinical Trials Resources

Human Subjects Research Requirements SOP and other Human Subjects SOPs