Emergency Use of an Investigational Product forms are available in Microsoft Word Format. To download a form, click on the link provided in the form title.
Instructions for Emergency Use | |
Form | |
Application Forms/ Templates
(1) Cover Memo | ||
Form | Type of Review | |
Full Board/Expedited |
(2) Emergency Use | |
Form | |
(3) Investigator Statement of Compliance | |
Form | |
Investigator Agreement (IDE trials) - This form is supplied by the sponsor when an IDE is involved. |
(4) Informed Consent | |
Form | |
Emergency Use Consent Template | |
Completion Guidelines/Instruction Sheet | |
(5) HIPAA | |
Form | |
Emergency Use HIPAA Authorization Template | |
Completion Guidelines/ Instruction Sheet | |
Guidelines for Use of HIPAA forms |
(6) Investigational Product | |
Form | |
Resources and Guidelines/ Instruction Sheets
(1) Protocol Review/ Submission | |
(2) Informed Consent | |
Form | |