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The NIAID Policy for Extension of Investigator-Initiated Clinical Trials provides PIs on investigator-initiated clinical trials with funds to complete or terminate a trial in an orderly fashion, under certain circumstances.
Occasionally, NIAID may administratively extend a clinical trial that could not be completed within the award period and budget. If the competing renewal process is more complex than is warranted, we may use a streamlined noncompetitive process, described in the NIAID Policy for Extension of Investigator-Initiated Clinical Trials.
You must be an NIAID grantee and meet the criteria in When would I need an administrative extension?
This approach is appropriate if a delay occurs for reasons you cannot anticipate or control, the reasons have been adequately addressed, and the clinical trial remains a high priority for NIAID.
You may be eligible for a noncompetitive extension if you have resolved delays associated with the following reasons:
Yes. Administrative extensions do not support extension of clinical trials due to the following types of delays:
No. You must have funds remaining to qualify for an administrative extension. If you run out of money, you can apply for an administrative supplement. Go to the Administrative Supplements to Grants and Cooperative Agreements SOP.
An administrative extension can support the full range of activities associated with clinical trials, including activities for the initial grant as well as those necessary to complete the trial during the extension period. In this way, it is the same as a traditional R01 or U01 clinical trial grant.
If your study does not meet the NIH Definition of Clinical Trial, it is not eligible for an administrative extension.
NIAID determines on a case-by-case basis if the clinical trial is being conducted under a training or fellowship grant. If appropriate, NIAID would consider providing funds to complete the clinical trial portion of the parent grant separately.
If the clinical trial is part of a larger study, NIAID determines this on a case-by-case basis. NIAID may consider extending the clinical trial portion of the parent grant separately.
Yes. Application packages for administrative extensions are short and undergo internal programmatic evaluation by NIAID staff instead of peer reviewers, so you can submit packages to NIAID at any time. The time between submission of the application package and a funding decision can be as little as 90 days.
Go to our Investigator-Initiated Clinical Trial Resources page.
Go to the Investigator-Intiated Clinical Trial Administrative Extensions SOP and follow the instructions.
If you conclude that you are a potential candidate, prepare all the required information and contact the NIAID program official listed in the NIAID Policy for Extension of Investigator-Initiated Clinical Trials Guide notice.
Yes. However, it will undergo the standard review process at NIH's Center for Scientific Review.
No. The NIAID Policy for Extension of Investigator-Initiated Clinical Trials is only for investigator-initiated applications. NIAID may make some exceptions if the solicitation (RFA/ PAR) is not reissued and the trial meets the criteria for this policy.
Yes. Because grant applications submitted in response to program announcements are considered investigator-initiated, clinical trials sponsored under program announcements and notices are eligible, especially if the program announcement or notice is terminated.
No. You must be a PI on an investigator-initiated clinical trial grant, and NIAID must invite you to apply. NIAID program staff will determine if you are a candidate. For more information, see the Investigator-Intiated Clinical Trial Administrative Extensions SOP.
Yes. NIAID Clinical Terms of Award will be part of the terms and conditions of award. Please see the NIAID Clinical Trial Implementation Cooperative Agreement (U01) program announcement for sample terms and conditions of award, which will be modified for each cooperative agreement.
Follow these steps:
If you are considering a request for permission to submit an administrative extension, please think about the following items at least 18 months before your award ends:
Then contact the person in the Guide notice, who will determine what you need to send in based on the circumstances of your extension.
The NIAID division director will send you a letter officially inviting you to submit an administrative extension package. Include this letter in your package.
NIAID’s goal is to respond to you within eight weeks after you contact the person listed in the Guide notice.
You can receive up to three years of support.
You may request funds up to the amount in the original grant with increases of up to 3 percent a year to perform the same work. However, under special circumstances and with adequate justification, we may provide funding for additional costs to perform the same work.
You may submit administrative extension packages to NIAID at any time. For earliest possible consideration for funding, submit it at least 90 days before a meeting of the NIAID advisory Council.
Yes. Check the human subjects box on the face page.
Use an abbreviated form of the PHS 398 application kit to provide the information listed in the NIH Guide notice, including a copy of the invitation from NIAID. Do not send your package to CSR, and do not apply electronically.
Send your package to the Grants Management Program, NIAID. For details, read the NIAID Policy for Extension of Investigator-Initiated Clinical Trials Guide notice.
NOT-AI-07-012: NIAID Policy for Extension of Investigator-Initiated Clinical Trials.
No. Except under exceptional circumstances, we will not extend a clinical trial more than once.
Yes. Only investigators who receive an official invitation letter from NIAID are allowed to submit administrative extension application packages.
No. Submit an abbreviated PHS 398 paper application.
NIAID staff, and possibly ad hoc consultants, will conduct an internal programmatic evaluation to determine whether you have adequately addressed the problems, your proposed research meets our current scientific priorities, and we can support the trial with existing resources. The review will use the criteria listed in the NIAID Policy for Extension of Investigator-Initiated Clinical Trials Guide notice.
Administrative extension applications do not undergo peer review.
We encourage you to contact other institutes to see if they might accept your renewal application because NIAID does not plan to routinely fund clinical trial grant renewals.
See Who can qualify for an administrative extension?
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Last Updated October 30, 2014
Last Reviewed September 16, 2014