Investigator-Initiated Applications for Clinical Trials (R01)

The Institute accepts investigator-initiated ap​plications for clinical trials using the R01 mechanism. Currently, two options are available:

PA-18-345 NIH Research Project Grant (Parent R01 Clinical Trial Required)
PAR-18-630 Investigator Initiated Extended Clinical Trial (R01)

Both R01 clinical trial application funding opportunity announcements feature:

Successful completion of advance planning for trial management and coordination is recommended for all multi-site or large-scale clinical trial applications to either funding opportunity announcement.

We strongly encourage advance discussion with NIGMS staff of all applications that involve clinical studies or clinical trials.  Clinical studies that do not meet the Revised NIH Definition of “Clinical Trial” should be submitted via the PAR-16-160 NIH Research Project Grant (Parent R01) funding opportunity announcement.  All clinical study and clinical trial applications above $500,000 direct costs in any one year are subject to NIH pre-submission requirements.