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 | |