VCU faculty-held IND or IDE
VCU policy and procedures
- VCU policy: Reporting sponsor-investigator investigational new drug applications (IND) or investigational device exemptions (IDE)
- Submit your IND or IDE via the VCU FDA submission portal
- Read the VCU Faculty Held IND and IDE procedure handbook
VCU forms and checklists
IND applications
FDA regulations
FDA guidance and forms
- FDA website for investigators
- Guidance for industry - E6(R2) good clinical practice: Integrated addendum to ICH E6(R1)
- FDA IND forms
FDA expanded access guidance and forms
- Form FDA 3926
- Individual patient expanded access applications: Form FDA 3926 guidance for industry
- Charging for Investigational Drugs Under an IND — Questions and answers guidance for industry
IND general information
- IND flowchart
- Determination of IND exemption for marketed drugs
- Step-by-step guide to submitting an IND
- Sponsor and investigator responsibilities
- Timetable for submission of required reports
- Required amendments and reports
IND templates
- Concurrence of exemption
- Letter of authorization to refer to your IND
- IND amendment: change in protocol
- IND amendment: new protocol
- IND amendment: new investigator
- IND annual report
- IND final report
- IND withdrawal request
- IND inactivation request
IND education
On-demand investigational new drug application sponsor and investigator training modules are available through Talent@VCU at go.vcu.edu/talentatvcu.
How to access modules in Talent@VCU:
- Log in to Talent@VCU at go.vcu.edu/talentatvcu
- Search for the course name or expand the subject drop-down and check “Research”
- Request and launch
IDE applications
FDA regulations
FDA guidance and forms
- FDA device advice website
- FDA IDE website
- How to classify your device
- Guidance for industry - E6(R2) good clinical practice: Integrated addendum to ICH E6(R1)
- FDA IDE forms
IDE general information
- IDE flowchart
- Significant risk IDE sponsor and investigator responsibilities
- Non‐significant risk IDE sponsor and investigator responsibilities
IDE templates
IDE education
On-demand investigational device exemptions sponsor and investigator training modules are available through Talent@VCU.
How to access modules in Talent@VCU:
- Log in to Talent@VCU at go.vcu.edu/talentatvcu
- Search for the course name or expand the subject drop-down and check “Research”
- Request and launch
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