Attend Sponsor Investigator Meeting

As defined by the Food & Drug Administration (FDA), a sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction an investigational drug or device is administered, dispensed, or used.  This individual submits and maintains the required IND (Investigational New Drug) Application or IDE (Investigational Device Exemption) Application and is responsible for complying with the FDA’s regulatory obligations for both the sponsor and the investigator roles.  The FDA specifies that this term does not include any person other than an individual, and as such, Indiana University will not submit or hold an IND or IDE application on behalf of its faculty or staff.  

To ensure that IU Sponsor-Investigators are aware of the expanded regulatory requirements, IU requires that all new sponsor-investigators attend an educational session with IU HRPP and Indiana CTSI representatives to review the additional responsibilities.  

• • This meeting must occur within 30 days of IRB initial approval.  
    • • An abbreviated process may be conducted if the sponsor-investigator has attended this session within the previous three years.
      • Other reasons for an abbreviated process are outlined in the IU HRPP Policy: Research Personnel Responsibilities.  
  • The sponsor-investigator’s study team and/or regulatory support staff are also encouraged to attend.  
  • Indiana CTSI and IU HRPP staff are available to answer additional questions related to the sponsor-investigator role prior to, and following, the required session.