Investigator-Initiated Clinical Trial Resources

Table of Contents

• Is Your Research Covered By NIAID's Policy?
• Learn More About the Process
• Request Preapproval
• Prepare Your Application
• If You Need an Extension After Award
• NIAID Division Clinical Web Sites
• Resources for NIAID Staff

Is Your Research Covered By NIAID's Policy?

If you plan an investigator-initiated clinical trial, you must go through NIAID's process for the following awards:

• Clinical trial planning grant (R34)—for investigators who need a planning phase.
• Milestone-driven implementation R01-- for investigators who are ready to begin a clinical trial that is not high-risk.
• Implementation cooperative agreement (U01)—for investigators who are ready to begin a high-risk clinical trial.

For NIAID's definition of risk, see How do I determine whether to apply for an R01 implementation grant or U01 implementation cooperative agreement?

An R34 is not a prerequisite for either the R01 or U01.

Learn More About the Process

• Get instructions at Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.
• Find answers at Investigator-Initiated Clinical Trials Questions and Answers.
• For NIAID's policy on investigator-initiated clinical trials, read the NIAID Policy: Investigator-Initiated Clinical Trials Guide notice.
• See the program announcements:
  • PAR-10-184, NIAID Clinical Trial Implementation Grant (R01)
  • PAR-10-185, NIAID Clinical Trial Planning Grant (R34)
  • PAR-11-234, NIAID Clinical Trial Implementation Cooperative Agreement (U01)

Request Preapproval

You must have our preapproval before you apply.

• Use Requesting Permission to Submit a Clinical Trial Planning (R34) or Implementation (R01 or U01) Application to prepare for and make your request.
• See the Preapproval Deadlines for Investigator-Initiated Clinical Trial Applications.
• Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.
• Include documentation of Institute preapproval with your application.

Prepare Your Application

In addition to the resources noted above, we have the following help for writing your application.

• All About Grants Tutorials
  • NIAID Human Subjects Application and Grant Handbook. Includes IRB and assurance information.
  • Checklists for Planning and Writing a Human Subjects Grant Application
  • Strategy for NIH Funding. Advice on how to plan and write an application and manage a grant.
• NIAID Clinical Terms of Award
  • Guidance on using the Terms
• Trans NIAID Clinical Research Toolkit
• Human Subjects Warning for Applications
• Sample Letter to Document Training in the Protection of Human Subjects

For more information, see NIAID Human Subjects Resources, including SOPs and questions and answers. Also learn more about Grant Application and Peer Review.

If You Need an Extension After Award

If you can't complete a clinical trial by the end of the award, you may be able to apply for an extension. For NIAID's policy on extending an investigator-initiated clinical trial, read the January 30, 2007, Guide notice and see the following pages:

• Investigator-Initiated Clinical Trial Administrative Extensions SOP
• Investigator-Initiated Clinical Trial Administrative Extensions questions and answers

NIAID Division Clinical Web Sites

• Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedure Documents
• Division of Microbiology and Infectious Diseases (DMID) Office of Clinical Research Affairs

Resources for NIAID Staff

• Request Form to Accept an Investigator-Initiated Clinical Trial Application

For more information, see NIAID Human Subjects Resources.