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)” or PAR-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.