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IND & IDE Support

ITHS › Investigators › Forms & Templates › IND & IDE Support

IND & IDE Support

IDE Templates & Forms

IDE Templates and Forms

For more information and guidance, see “IDE Development.” External LinkFDA Forms66 kBStudy Protocol for a medical device study32 kBIDE Submission22 kBIDE Cover Letter110 kBAll IDE Templates

IND Templates & Forms

IND Templates and Forms

For more information and guidance, see “IND Development.”

Initial Submission

External LinkFDA Forms22 kBRequest for IND Waiver 26 kBRequest for Pre-IND Meeting17 kBPre-IND Briefing Packet82 kBStudy Protocol for a drug study42 kBIND Submission22 kBIND Cover Letter

Protocol Amendments

23 kBIND Protocol Amendment Cover Letter – New Investigator23 kBIND Protocol Amendment Cover Letter – New Protocol or Change in Protocol897 kBFDA Form 1572105 kBFDA Form 1572 FAQs – final guidance

Safety Reports

External LinkIND Safety Report – MedWatch Form FDA 3500A23 kBIND Safety Report Cover Letter

Annual Reports

41 kBIND Annual Report22 kBIND Annual Report Cover Letter

Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.