Sponsor-Investigator Training

Offered on an as-requested basis, this training is required for Principal Investigators who are also taking on the role of Sponsor for an FDA-regulated drug or device study per HRPP Policy 6.2.3.1. A sponsor is an individual who holds an IND (Investigational New Drug) or IDE (Investigational Device Exemption) and is responsible for the initiation, conduct, and overall oversight of the clinical trial. 

Sponsor-Investigator training is held upon request and is one 2-hour session. While this training is required for the PI serving as an Sponsor-Investigator, any member of the research team can attend at the PI’s discretion. 

Please contact us to schedule the Sponsor-Investigator Training. Note that training is required to be completed prior to IRB approval of research. We recommend that the training request be submitted to us at the same time as IRB submission to ensure completion prior to study approval. 

It is also recommended that all Sponsor-Investigators complete PI Training to gain a more fundamental understanding of the oversight responsibilities any Principal Investigator has. This is not required as a prerequisite for requesting Sponsor-Investigator training, only a recommendation. 

Additional Resources for Sponsor-Investigators

• Institutional Resources
  • HRRP Policy 12.1 Investigational New Drug (IND) Application
  • HRPP Policy 12.2 Investigational Device Exemption (IDE)
• FDA Resources  
  • Investigational New Drug Application
    • 21 CFR 312 Investigational New Drug Application Regulations
  • Investigational Device Exemption
    • 21 CFR 812 Investigational Device Exemptions Regulations
  • 21 CFR 50 Protection of Human Subjects Regulations
  • FDA Guidance Documents and Information Sheets: note that many of these documents are considered “drafts” by the FDA and contain “non-binding recommendations”. These guidance documents still can be used to guide investigators in complying with requirements despite their draft designation.
    • Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects
    • Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
    • Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring
    • Frequently Asked Questions Statement of Investigator on the Form FDA 1572
    • Significant Risk and Nonsignificant Risk Medical Device Studies
    • Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
    • Adverse Event Reporting to IRBs – Improving Human Subject Protection
    • Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND
  • BU CTSI and Duke CTSI collaborated on presenting training on IND and IDE submissions and are available for review. Please note that this training was presented in 2013 and 2014 and these slides may represent outdated information. 
    • Investigational New Drug Materials
      • IND Exemption, Preparation and Maintenance (2013)
      • IND Exemption, Preparation and Maintenance: Best Practices Workshop (2014)
      • IND Exemption: Case Scenarios (2014)
    • Investigational Device Exemption Materials
      • IDE Exemption, Preparation and Maintenance (2013)
      • IDE Preparation and Maintenance: Best Practices Workshop (2014)