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)

Document Locations

Protocol

(Basic Information page)

• Investigator protocol
• Complete sponsor protocol
• Site supplement to sponsor protocol
• HHS (Department of Health and Human Services) protocol

Funding information

(Funding Sources page, with each source)

• Grant applications

Drug details

(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

Device Details

(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

Recruitment and Consent Details

(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

All Other Relevant Documents

(Study-Related Documents page)

• Consent document templates for use by participating sites
• Recruitment materials templates for use by participating sites
• Other supporting documents needed by participating sites
   

Article ID: 93
Created: February 13, 2025
Last Updated: February 13, 2025

Online URL: https://ohiostateresearch.knowledgebase.co/article/huron-irb-checklist-of-information-to-attach-93.html