Investigator-Initiated Applications for Clinical Trials (R01)

The Institute accepts investigator-initiated ap​plications for clinical trials using the R01 mechanism:

PA-19-055: NIH Research Project Grant (Parent R01 Clinical Trial Required)
PA-18-630: Investigator Initiated Extended Clinical Trial (R01) (NIGMS no longer participates​)

The R01 clinical trial application funding opportunity announcement features:

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-19-056 ​NIH Research Project Grant (Parent R01 Clinical Trial Not Al​lowed)​ 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.