IND Confirmation that it’s OK to Proceed
IND_Confirmation that it's OK to Proceed _Letter_2019
File: IND_Confirmation-that-its-OK-to-Proceed-_Letter_2019.docxIND/IDE
Policy FDA Regulated Research Compliance Review
This policy describes the Oversight Program's performance of routine compliance reviews of clinical trials conducted under UW-Madison Investigator held INDs or IDEs to ensure compliance with applicable laws, regulations, policies and guidelines.
Policy_FDA Regulated Research Compliance Review_2019.11.15
Updated 11/18/2019
File: Policy_FDA-Regulated-Research-Compliance-Review_2019.11.15.pdfHandling External Inspections and Audits Policy
This policy requires UW-Madison faculty and staff to notify campus officials of FDA inspections and audits by other external agencies (e.g., National Institutes of Health).
Policy_Handling External Inspections and Audits Policy_2019.11.15
Updated 11/18/2019
File: Policy_Handling-External-Inspections-and-Audits-Policy_2019.11.15.pdfIDE Formal Progress Report
Investigational Device Exemption Formal Progress Report Template
File: IDE_Formal_Progress_Report-2018.docIDE Informal Progress Report
Investigational Device Exemption Informal Progress Report Template
File: IDE_Informal_Progress_Report-2018.docIDE Application Cover Letter
Investigational Device Exemption Application Cover Letter Template
File: IDE_Application-Cover_Letter_2018.docxIDE Application Template
Investigational Device Exemption Application Template
File: IDE_Application_Template_2018.docxPre-IND Briefing Packet Template
Pre-IND Briefing Packet Template
File: Pre-IND_Briefing_Packet-Template-2018.docxRequest for Pre-IND Meeting Template
Request for Pre-IND Briefing Meeting Template
File: Request_For_Pre-IND_Meeting-Template-2018.docxIND Exemption Letter Brief
Investigational New Drug IND Exemption Letter brief version
File: IND_Exemption_Letter-Brief-2018.docx