Questions and Answers Table of Contents
General Questions
Questions on Applying
NIAID Approval and Review Questions
General Questions
What is the new NIAID Policy for Extension of Investigator-Initiated
Clinical Trials?
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.
Why is NIAID adopting this approach?
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.
Who can qualify for an administrative extension?
You must be an NIAID grantee and meet the criteria in When would I need an administrative
extension?
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:
- Difficulties obtaining suitable study agent.
- Difficulties meeting enrollment schedule.
- Difficulties obtaining assurances and certifications.
- Difficulties with access to suitable facilities.
- External hold ups at regulatory or funding agencies (not related
to safety).
- Litigation involving any of the above.
- Changes in public health policy or standards of care.
Are there circumstances when an administrative extension would not be appropriate?
Yes. Administrative extensions do not support extension of clinical
trials due to the following types of delays:
- Natural disasters or declared emergencies (NIH will address these situations).
- Safety concerns.
- Persistent systemic problems.
- Suspension of grant activities.
- Vandalism or other isolated events unrelated to the trial.
If I run out of money, can I still qualify?
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.
What can an administrative extension support?
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.
Are there activities an administrative extension cannot support?
Yes. An administrative extension cannot support planning a clinical trial, such as developing a protocol,
informed consent documents, investigator's brochure, or a package for regulatory (e.g., FDA) submission. If you need support for planning activities, go to NIAID Clinical Trial Planning Grants (R34).
Further, you cannot use an extension to resolve issues that caused the delay. You must resolve these issues before submitting the administrative extension package.
What if my research does not meet the NIH definition of a clinical trial?
If your study does not meet the NIH definition of a clinical trial, it is not eligible for an administrative extension.
What if my ongoing clinical trial is a part of a training grant or fellowship?
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.
Can I apply if my clinical trial is part of a single project grant or one project on a multi-project grant?
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.
Are there benefits to PIs other than those listed above?
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.
Where can I find more information about clinical trial planning and implementation grants for new clinical trials?
Go to our Investigator-Initiated Clinical Trials Resources page, and contact the staff members listed in the NIAID Clinical Trial Planning Grants (R34) and NIAID Clinical Trial Implementation Cooperative Agreement (U01) program announcements and the Investigator-Initiated Clinical Trial Planning and Implementation Grants SOP.
What's the first thing I should do if I think I’m eligible for an administrative extension?
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.
Can I still submit a renewal application for my investigator-initiated
clinical trial grant?
Yes. However, it will undergo the standard review process at NIH's Center for Scientific Review.
Does the new approach affect requests for applications or requests for proposals?
No. The NIAID
Policy for Extension of Investigator-Initiated Clinical Trials is only for investigator-initiated applications. NIAID may make some exceptions if the RFA or RFP is not reissued and the trial meets the criteria for this policy.
Does an administrative extension apply
to clinical trials initiated under program announcements?
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.
Can anyone apply for an administrative extension?
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.
Do NIAID's clinical terms of award apply to my administrative extension?
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.
Questions on Applying
How do I apply for an administrative extension?
Follow these steps:
- Review the Investigator-Intiated Clinical Trial
Administrative Extensions SOP for the information to discuss with the
NIAID contact listed in the Guide notice.
- Telephone or email the NIAID contact listed in the NIAID
Policy for Extension of Investigator-Initiated Clinical Trials NIH
Guide notice, not your program officer, to discuss your potential candidacy.
- Follow the instructions in the Guide notice,
and wait for NIAID to notify you. If
you are a candidate for an extension award, you will
receive an invitation to submit the application.
- See the questions below for further details.
What information may NIAID request to help determine whether I am a candidate?
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 grant ends:
- 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.
Then contact the person in the Guide notice, who will determine what you need
to send in based on the circumstances of your extension.
Do I need to prepare a letter of intent?
No.
How do I know if I am a candidate for an administrative 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.
What is the timeframe for a response from NIAID regarding approval to submit my application?
NIAID’s goal is to respond to you within eight weeks after you
contact the person listed in the Guide notice.
How much time can I request for an administrative extension?
You can receive up to three years of support.
How much money can I request for an administrative extension?
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.
When can I submit my administrative extension package?
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.
Should I indicate on the face page of my administrative extension application that human subjects are involved?
Yes. Check the human subjects box on the face page.
How do I prepare and submit my administrative extension application package?
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.
Where should I send my administrative extension application package if NIAID invites me to submit one?
Send your package to
the Grants Management Program, NIAID. For details, read the NIAID
Policy for Extension of Investigator-Initiated Clinical Trials Guide notice.
What notice should I indicate on the face page?
NOT-AI-07-012: NIAID Policy for Extension of Investigator-Initiated Clinical Trials.
Can I submit a revised administrative extension application package?
No. Except under exceptional circumstances, we will not extend a clinical trial more than once.
Do I need permission to submit an administrative extension application?
Yes. Only investigators who receive an official invitation letter from NIAID are allowed to submit administrative extension application packages.
Should I submit an administrative extension package electronically?
No. Submit an abbreviated PHS
398 paper application.
NIAID Approval and Review Questions
How does the NIAID process for evaluating administrative extension packages differ from peer review?
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.
Who will peer review the administrative extension applications?
Administrative extension applications do not undergo peer review.
If I am not an NIAID grantee, how can I renew my clinical trial grant?
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?
What if my question wasn't answered here or if I'd like to suggest a question?
Email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.
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