Huron IRB - Checklist of Information to Attach

Document Upload Guidelines

Each study SmartForm 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)

• Ohio State-specific Huron protocol template and associated appendices
• 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:
  • Ohio State-specific consent templates
  • Non-English consent documents
  • HHS-approved consent document
  • For non-written consent, a script of the information provided orally to the participants
• Recruitment materials: 
  • Advertisements (final copy of  printed, audio, and video ads)
  • Announcements, flyers, posters, letters/emails, bulletin board tear-offs, internet postings, and telephone scripts
  • Non-English versions of recruitment materials
• Other Attachments: 
  • Data collection forms, participant materials, participant diaries, and/or other instruments
  • Data safety monitoring plans
  • Data sharing plans
  • Eligibility questionnaires and evaluation instruments
  • Materials associated with protocol appendices (i.e., radiation calculator results)
  • Non-English versions of participant materials 
  • Participant newsletters, instruction sheets, study-specific appointment reminder cards, drug/device information
  • Surveys, questionnaires, interview/focus group guides
  • Conflict of interest committee determinations for each financial interest related to the research
  • Completed Department of Energy checklist

Multi-site Study 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 (e.g., data collection forms, surveys, interview guides, debriefing scripts)