IND Holder Responsibilities: The Role of the Sponsor-Investigator

Nov 8, 2018

02:00 PM - 03:00 PM

Pomerantz Family Pavilion, Braley Auditorium (01136 PFP)

720 Melrose Avenue, Iowa City, IA 52242

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The Principal Investigator becomes the sponsor-investigator of a project when they hold an Investigational New Drug (IND) application to the FDA.  This includes added responsibilities for record keeping and reporting, both to the FDA and to the IRB, beyond what a PI would normally do for research where the sponsor holds the IND. This session will focus on sponsor-investigator responsibilities AFTEr the IND is received:

  • An overview of the roles of the sponsor and the investigator as IND holder
  • A review of FDA regulations and UI IRB policies and procedures about PI oversight responsibilities. 
  • FDA warning letters (and how to avoid receiving one)

Researchers who may apply for a future IND and current sponsor-investigators are encouraged to attend this presentation for an orientation or a review of the roles and responsibilities of an IND-holder.

Please register at https://uiowa.qualtrics.com/jfe/form/SV_9SGBJdh2c4g1kjP. 

Individuals with disabilities are encouraged to attend all University of Iowa–sponsored events. If you are a person with a disability who requires a reasonable accommodation in order to participate in this program, please contact in advance at