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Dear Collegues,
Would appreciate input on submission of the Transfer of obligations/Responsibilities (TORO) to IND, for a Phase 1 Study – Scenario and Question, below.
Scenario: signed/finalized TORO of the study is yet to be submitted to US IND; and during the course of the study one of the probe drugs for one of the multiple study arms, is switched to a new probe; meanwhile some arms (unaffected by probe change) of the study completed the enrollment (with no pending study procedures and no further enrollment in these arms). The study has an updated name (with the new probe).
Question - If the signed TORO with the original study name is yet to be submitted to the IND, should the TORO with the revised study name be submitted to IND or the original TORO will suffice? If the original TORO can be submitted should there be a Note-to-File with it?
Thank you