New resources have been added to the Regulatory Services – Investigator-Initiated Trials page on the website. Please refer to these documents for guidance regarding Sponsor-Investigator responsibilities and assessment of IND/IDE determinations during development of Investigator-initiated trials. These include:
- Sponsor-Investigator IND Training slides
- Investigator Checklist for IND Exemption
- Investigator Checklist for IDE Exemption
Please reach out to CTO-Regulatory at email@example.com for questions or assistance.