Huron IRB - Checklist of Information to Attach

Document Upload Guidelines

Each study form has specific places to attach files. Some sections provide templates you can download and use, like the protocol template.

Before You Upload:

File names will appear on your IRB approval letter exactly as you write them
Make sure to upload each document type in its correct section (see locations below)

(Basic Information page)

(Funding Sources page, with each source)

(Drugs page, with each drug, or on main Drugs page if not specific to one drug)

Package insert
Investigator brochure
Verification of each IND number (one of these):
- Sponsor protocol with the IND number
- Communication from the FDA or sponsor with the IND number

(Devices page, with each device, or on main Devices page if not specific to one device)

Product labeling/device instructions
Investigator brochure
Verification of each IDE or HDE number (one of these):
- Sponsor protocol with the IDE / HDE number
- Communication from the FDA or sponsor with the IDE / HDE number

(Local Site Documents page)

Consent documents:
- Consent forms
- HHS-approved consent document
- For non-written consent, a script of the information provided orally to the subjects
All material to be seen or heard by subjects, such as:
- Evaluation instruments and surveys
- Advertisements, including printed, audio, and video
- Recruitment materials and scripts
Foreign-language versions of materials for subjects
Supporting document and other attachments:
- Conflict of Interest Committee's determination for each financial interest related to the research
- Completed checklist of meeting Department of Energy requirements

(Study-Related Documents page)