Investigator-Initiated Clinical Trials Resources

For more information, see Human Subjects.

This is the homepage for NIAID's R34 Clinical Trial Planning Grants, U01 Clinical Trial Implementation Cooperative Agreements, and Clinical Trial Administrative Extensions.

Apply electronically for an R34; use a paper PHS 398 to apply for a cooperative agreement or administrative extension.

R34 and U01 Resources for Investigators

• Guide notices with contact information:
  • NIAID Clinical Trial Planning (R34) Grants
  • NIAID Clinical Trial Implementation (U01) Cooperative Agreement
  • New NIAID Policy: Investigator-Initiated Clinical Trials
• Requesting Permission to Submit a Clinical Trial Planning (R34) or Implementation (U01) Grant Application
• Investigator-Initiated Clinical Trial Planning and Implementation Grants questions and answers
• Investigator-Initiated Clinical Trial Planning and Implementation Grants SOP

Administrative Extension Resources

• Investigator-Initiated Clinical Trial Administrative Extensions SOP
• Investigator-Initiated Clinical Trial Administrative Extensions questions and answers
• Guide notices with contact information:
  • NIAID Policy for Extension of Investigator-Initiated Clinical Trials

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

Other Clinical Resources for Investigators

• NIAID Human Subjects, Clinical Research
• Other Clinical Research Links
• Trans NIAID Clinical Research Toolkit

Resources for Staff

• Request Form to Accept a Clinical Trial Planning (R34) or Implementation (U01) Grant Application

For more information, see Human Subjects.