See the Glossary for more terms.
Related SOP: Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP
Use this document to:
For timing of your prior consultation request, see the Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications.
For general information on investigator-initiated clinical trial planning (R34) and implementation (R01, U01, or U44) awards, go to Investigator-Initiated Clinical Trial Resources.
Go to the next steps to determine readiness and risk.
To be ready to undertake a clinical trial, you must have ready all documentation you would have prepared during an R34 clinical trial planning grant.
See the lists of documentation to prepare for the prior consultation in the implementation award sections of the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.
If you are not ready to implement a clinical trial, go to step 4 to request prior consultation from NIAID for an R34 clinical trial planning grant.
Choose which award type to apply for based on level of risk. The Clinical Trial Implementation Cooperative Agreement (U01) supports high-risk clinical trials as described in the funding opportunity announcement.
For studies that are not high risk, applicants may apply for the Clinical Trial Implementation Grant (R01) or Investigator-Initiated Extended Clinical Trial (R01).
The SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) award encourages high-risk clinical studies, though applicants may also propose studies that are not considered high risk.
(NIAID may determine that substantial staff involvement is necessary for other reasons and ask you to apply for a U01.)
Before contacting a program officer, do the following:
After you have a prior consultation with NIAID program staff, submit the following to the NIAID program officer in five pages or less:
For more information, see our Investigator-Initiated Clinical Trial Resources.
Last Updated September 25, 2015
Last Reviewed September 25, 2015