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Standard Operating Procedure Table of Contents
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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
a program staff member listed in the January
30, 2007, Guide notice 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:
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
- The NIAID division contact 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 division contact listed below.
Program Division Contacts
- Use your internal divisional process
and consult DEA OD to determine whether the clinical trial meets the Eligibility Criteria.
- If the clinical trial is eligible, use your internal divisional process to determine whether the trial fits the Candidacy Criteria for an administrative extension.
- If so,
invite the PI to submit an application. Use the sample
type 4 acceptance form letter, and copy the DEA OD, Budget, and GMP contacts listed below.
- After receiving the application, ensure that it meets Internal Programmatic Evaluation (IPE) Criteria. Prepare documentation of the
evaluation's outcome and submit it to your management and DEA OD.
- If the outcome of the programmatic evaluation is favorable, prepare a clinical extension nomination package.
- If the outcome of the NIAID-level consideration is favorable, prepare a special issue worksheet. Provide the special issue worksheet and nomination package to Council for approval. Include the following:
- Budget level and time period of up to three years.
- First five pages of the extension application. If the budget page
is not in the first five pages, provide all pages through the budget
page.
- Identify the grant by using the type 4, not the original, grant number.
Note: Council must discuss type 4s, not review them en bloc.
Grants Management Staff
- After the contact person listed under Principal Investigators receives the application, provide copies to the appropriate grants division coordinator, who will perform an initial administrative review.
- Keep the original application in the official GMP grant file. Then provide copies of the application, along with a list of any missing information or materials, to the division contact listed below, the grants management coordinator, the grants management specialist, and DEA OD.
- Review Council's recommendations to determine if the outcome of the internal programmatic evaluation is favorable. If so, send a copy of the application to CSR and enter any necessary information into the Council Action and Approval Program.
- If Council recommends the application for funding, work with the program division contact and program officer and use standard procedures for Method to Extend Research In Time (MERIT) extensions to make the award.
Contacts
Applicants with questions should contact the appropriate person listed below.
Send general inquiries concerning extension of clinical trials to:
Anna Ramsey-Ewing, arewing@niaid.nih.gov, 301-435-8536
For inquiries about programmatic issues contact:
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
For inquiries about grants management issues contact:
Laura Eisenman, leisenman@niaid.nih.gov, 301-402-5541
If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.
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 |