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Standard Operating Procedure Table of Contents
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Purpose
This SOP describes the clinical trial planning and implementation grant process for investigator-initiated clinical trials.
Procedure
Applicants -- R34 Process
Applicants -- U01 Process
- NIAID R34 recipients may apply for a U01. Read the Clinical Trial Implementation (U01) Cooperative Agreement Guide notice for details.
- Speak with the appropriate NIAID division point of contact identified in the Guide notice. That person can answer your questions and refer you to the appropriate program officer.
- For grant applications with budgets that exceed $500,000 in direct costs in any year of the grant, request preapproval to submit an U01 application from the NIAID program officer.
- Review the list of information you will need to provide the program officer at Requesting Permission to Submit a Clinical Trial Planning (R34) or Implementation (U01) Grant Application. Before you prepare anything, call the program officer for help with the process.
- Send NIAID your written request for preapproval at least ten weeks before the receipt date.
- The program officer sends your request through an internal NIAID approval process.
- Within six weeks, you will receive a letter signed by the relevant division director or designee informing you whether your request has been approved.
- If NIAID approves your request, you may apply.
- Prepare your application using the PHS 398. Follow the Clinical Trial Implementation (U01) Cooperative Agreement Guide notice for additional instructions.
- Send your application in time for CSR to receive it on or before the Standard NIH Receipt Date.
- NIAID special emphasis panel members will peer review your application. Contact the scientific review officer for questions during review and contact the program officer after review.
- If successful, you will receive an award about four months after NIH receives your application.
- If you're unable to complete a trial within
the performance period of your award, read the NIAID
Policy for Extension of Investigator-Initiated Clinical Trials Guide notice.
Contact the program officer listed in this notice to see if
NIAID will consider extending your award.
Program Division Staff and Management
Divisions preapprove submission requests based on Institute priorities and available resources.
R34 Preapproval Process
- The program officer completes Sections A, B, E, and F of the Request Form to Accept a Clinical Trial Planning (R34) or Implementation (U01) Grant Application and emails it to the division director.
- The division director completes Section C of the form. He or she has authority to accept R34 grant applications.
- After the approval is complete, a program staff member prepares a letter for the division director's signature.
- The program officer sends the applicant the signed letter stating whether the project was approved.
U01 Preapproval Process -- Applications with Budgets over $500,000
For an application with a budget over $500,000 in direct costs in any one year, the applicant requests preapproval to submit a U01 application from the NIAID program officer.
Contacts
Patricia Haggerty, Ph.D.
Division of Extramural Activities
301-451-2615
Email: haggertp@nih.gov
Martin Gutierrez
Division of AIDS
301-451-2703
Email: mgutierrez@niaid.nih.gov Josiah Wedgwood, M.D., Ph.D.
Division of Allergy, Immunology, and Transplantation
301-496-7104
Email: jwedgwood@niaid.nih.gov
Shy Shorer, M.D.
Division of Microbiology and Infectious Diseases
301-451-3025
Email: shorers@niaid.nih.gov
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
Request Form to Accept a Clinical Trial Planning (R34) or Implementation (U01) Grant
Human Subjects Research Requirements SOP and other Human Subjects SOPs
Investigator-Initiated Clinical Trials Resources main page
Trans
NIAID Clinical Research Toolkit
Program announcements
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