Investigator-Initiated Clinical Trial Planning and Implementation Grants

Purpose

This SOP describes the clinical trial planning and implementation grant process for investigator-initiated clinical trials.

Procedure

Applicants -- R34 Process

• Read the Clinical Trial Planning (R34) Grants Guide notice for details. Also read Requesting Permission to Submit a Clinical Trial Planning (R34) or Implementation (U01) Grant Application.
• 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.
• Request approval to submit an R34 application from the 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, prepare your application using the electronic application package.
  • To find it, go to the Guide notice, PAR-06-384, NIAID Clinical Trial Planning Grants, then click the "Apply for Grant Electronically" button to reach the download page.
  • Follow the package's instructions.
• 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.

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.

• 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.
• The division director forwards the request form to the email group NIAID DivDir with a copy to NIAID Inv. Init. ClinTrials for approval. This information must be sent to NIAID DivDir at least one week before the request is to be discussed.
• After members of NIAID DivDir make a decision, the group emails NIAID DAIDSFunding, NIAID DAITFunding, or NIAID DMIDFunding with a copy to NIAID Inv. Init. ClinTrials. 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.

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

• NIAID Clinical Trial Planning (R34) Grants
• NIAID Clinical Trial Implementation (U01) Cooperative Agreement