See the Glossary for more terms.
Some links will work for NIAID staff only.
This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
To support investigator-initiated clinical trials through planning grants (R34), implementation grants (R01), or implementation cooperative agreements (U01) through a defined policy and process.
To apply for an award to support an investigator-initiated clinical trial, applicants must go through the following process.
Applicants apply for one of these awards:
If you need support to get ready for the launch of an IICT, such as planning, designing, and preparing the documentation necessary for implementing an IICT, consider applying first for a Clinical Trial Planning Grant (R34). An R34 is not a prerequisite for either the R01 or U01.
All those application types will benefit from prior consultation with program staff, as described below.
*For NIAID's definition of high and non-high risk, see R01 Process for Applicants and PIs and U01 Process for Applicants and PIs below.
You are strongly encouraged to request a prior consultation with NIAID staff at least 10 weeks before the application due date.
The program officer will give you a letter signed by the NIAID division director that summarizes the prior consultation discussion. Attach the letter as a PDF file in the PHS 398 Cover Letter File of your grant application package. Include the name of the program officer who handled your request.
The time frames listed below are minimums; start the process as soon as possible. See the Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications.
Last Updated February 18, 2015
Last Reviewed September 16, 2014