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		Search Text: Home/Grants and Training/< Back ToPolicies, Procedures, and Guidelines/IND/IDE authorization timing requirement for PAR-18-406 and PAR-18-407

IND/IDE authorization timing requirement for PAR-18-406 and PAR-18-407
                                    
                                                                                                    
                                                                                                    
                                                                                                    Are you in the process of applying for an NHLBI single or multi-site clinical trials grant?

If so, we want to inform you that there has been a change regarding when investigators must obtain their Investigational New Drug (IND) authorization or Investigational Device Exemption (IDE) approval.

Applicants applying to PAR-18-406, "Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)” orPAR-18-407"Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)” must now obtain and provide all necessary regulatory approvals to NHLBI**before** the initial award will be made.

Thus, instead of obtaining **IND authorization or IDE approval during the initial phase of the award (UG3 or R61, respectively), applicants must now have those approvals in place****before****awards are made.**

This change is effective with the **June 13, 2018** application due date.

Read more about these changes here:

https://grants.nih.gov/grants/guide/notice-files/NOT-HL-18-625.html
	https://grants.nih.gov/grants/guide/notice-files/NOT-HL-18-626.html Back To Top Link
  

        

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