See the Glossary for more terms.
Some links will work for NIAID staff only.
This standard operating procedure includes the following sections: Purpose, Procedure, Contacts, and Links.
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.
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:
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.
Applicants with questions should contact the appropriate person listed below.
Contact for General Inquiries
Program Division Contacts
Grants Management Contact
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Investigator-Initiated Clinical Trial Administrative Extensions questions and answers
Investigator-Initiated Clinical Trial Resources
Human Subjects Research Requirements SOP and other Human Subjects SOPs
Last Updated February 14, 2013
Last Reviewed September 16, 2014