See the Glossary for more terms.
Related SOP: Investigator-Initiated Clinical Trial Planning and Implementation Awards
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 or U01) 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 R01 and U01 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.
Apply for an investigator-initiated clinical trial implementation R01 if you propose a clinical trial that is not high risk, which we define as follows:
If either of these circumstances is the not case, your trial is high risk, and you must apply for a clinical trial implementation U01.
(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 for an R34, R01, or U01 application, 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 March 29, 2013
Last Reviewed September 16, 2014