Forms and Processes

• Budget Template
• Training Grants - Restricted to UMN Fac/Staff/Students
• Proposals - Restricted to UMN Fac/Staff/Students
• Protocols
• Drug Studies
• Device Studies
• Pilot Studies
• Small (< 20 Subjects)
• Large (> 20 Subjects)
• Very Large (> 100 Subjects)
• Single site
• Multi-site
• Sponsor-investigator
• Inclusion/Exclusion form (individual subject)
• Inclusion/Exclusion tracker (everyone screened)
• Subject tracking spreadsheet
• Consent form & HIPAA tracking spreadsheets
• Drug accountability log
• Monitoring plan
• Monitoring worksheets (to document monitoring activities)
• Adverse event tracker
• Link to IRB AE reporting rules
• Link to IRB application
• Email link to request/schedule monitoring visit (for new and continuing studies)
• Tabs for regulatory binders (to help sites (know &) maintain required documents.
• Other essential documents (ICH E6) templates
• Case Report Form (CRF)
• Small (< 20 Subjects)
• Large (> 20 Subjects)
• Very Large (> 100 Subjects
• Visual based data collection
• Questionnaire only (CRF is source document)
• Records-based (data culled from subject medical records)