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A NIAID Approach to Sponsor Responsibilities under 21CFR 312.32 (b)

Thursday, November 07, 2013 — Poster Session II

12:00 p.m. – 2:00 p.m.

FAES Academic Center (Upper-Level Terrace)




  • Karen Sweeney
  • Barry Eagel
  • Marc Teitelbaum
  • Debbi Hissey
  • Kelly Cahill


Problem Statement: Effective September 2011, changes to 21CFR312.32 increased sponsor safety oversight requirements. The CSO had limited safety oversight in reviewing safety data except through Serious Adverse Event (SAE) Reports, as they occurred, and reconciliation of SAEs for Investigational New Drug (IND) Annual Reports. Solution: NIAID and the CSO implemented a new process requiring active sponsor safety surveillance assessments in an effort to comply with the changes to 21CFR312.32. The process initially applied to NIAID sponsored IND studies approved on or after September 1, 2011 and included a formal agreement with Principal Investigators (PI) through a Safety Review and Communications Plan (SRCP) or transferring the sponsor’s responsibility for conducting periodic safety surveillance assessments to the PI through a Transfer of Regulatory Obligations (TORO).

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