IRB Forms and SOP

• Statement of Compliance
• 000-099 SOP
• 100-199 GENERAL DOCUMENTS
• 200-299 FORMS
• 300-399 WORKSHEETS
• 400-499 CHECKLISTS
• 500-599 TEMPLATES
• 600-699 DATABASES
• 800-899 sIRB DOCUMENTS

All .docx files unless otherwise indicated

000-999 SOPS

• 000-019 GENERAL
  • HRP-001 SOP - Definitions
  • HRP-012 - SOP - Observation of Consent Process
  • HRP-013 - SOP - LARs, Children, and Guardians
• 020-029 MANAGEMENT OF INCOMING INFORMATION
  • HRP-020 - SOP - Incoming Items
  • HRP-021 - SOP - Pre-Review
  • HRP-023 - SOP - Emergency Use, Compassionate Use, Indiv Patient Expanded Access
  • HRP-024 - SOP - New Information
  • HRP-025 - SOP - Investigations
  • HRP-026 - SOP - Suspension or Termination Issued Outside of Convened IRB
  • HRP-026 - SOP - Suspension or Termination
  • HRP-027 - SOP - Emergency Use and Device Compassionate Use Post-Review
• 030-039 NON-COMMITTEE-REVIEW
  • HRP-030 - SOP - Designated Reviewers
  • HRP-031 - SOP - Non-Committee Review Preparation
  • HRP-032 - SOP - Non-Committee Review Conduct
• 050-059 REVIEW PROCESS
  • HRP-050 - SOP - Conflicting Interests of IRB Members
  • HRP-051 - SOP - Consultation
  • HRP-052 - SOP - Post-Review
  • HRP-054 - SOP - Institutional Conflicts of Interests
  • HRP-055 - SOP - Financial Conflicts of Interests
• 060-069 PERIODIC TASKS
  • HRP-060 - SOP - Annual Evaluations of the HRPP
  • HRP-061 - SOP - Monthly Evaluations of the HRPP
  • HRP-062 - SOP - Daily Tasks
  • HRP-063 - SOP - Expiration of IRB Approval
  • HRP-064 - SOP - NIH GDS Institutional Certification
• 070-079 RECORDS
  • HRP-070 - SOP - IRB Records
  • HRP-071 - SOP - Standard Operating Procedures
  • HRP-072 - SOP - IRB Records Retention
• 090-099 INVESTIGATOR
  • HRP-090 - SOP - Informed Consent Process for Research
  • HRP-091 - SOP - Written Documentation of Consent

• Statement of Compliance

• 000-099 SOP

• 100-199 GENERAL DOCUMENTS

• 200-299 FORMS

• 300-399 WORKSHEETS

• 400-499 CHECKLISTS

• 500-599 TEMPLATES

• 600-699 DATABASES

• 800-899 sIRB DOCUMENTS

100-199 GENERAL DOCUMENTS

• HRP-100 - Huron HRPP Toolkit Table of Contents
• HRP-101 - HUMAN RESEARCH PROTECTION PROGRAM PLAN
• HRP-102 - Flowcharts.pdf
• HRP-102 - Flowcharts.vsd
• HRP-103 - INVESTIGATOR MANUAL
• HRP-103p - INVESTIGATOR MANUAL - pSite
• HRP-104 - BROCHURE - Should I Take Part in Research

HRP-200-299 FORMS

• HRP-202 - FORM - IRB Member Information
• HRP-211 - FORM - Basic Study Information
• HRP-212 - FORM - Continuing Review
• HRP-213 - FORM - Modification
• HRP-214 - FORM - Reportable New Information

300-399 WORKSHEETS

• HRP-301 - WORKSHEET - Review Materials
• HRP-302 - WORKSHEET - Approval Intervals
• HRP-303 - WORKSHEET - Communication of Review Results
• HRP-304 - WORKSHEET - IRB Composition
• HRP-305 - WORKSHEET - Quorum and Expertise
• HRP-306 - WORKSHEET - Drugs and Biologics
• HRP-307 - WORKSHEET - Devices
• HRP-308 - WORKSHEET - Pre-Review
• HRP-310 - WORKSHEET - Human Research Determination
• HRP-311 - WORKSHEET - Engagement Determination
• HRP-312 - WORKSHEET - Exemption Determination
• HRP-313 - WORKSHEET - Expedited Review
• HRP-314 - WORKSHEET - Criteria for Approval
• HRP-315 - WORKSHEET - Advertisements
• HRP-316 - WORKSHEET - Payments
• HRP-317 - WORKSHEET - Short Form of Consent Documentation
• HRP-318 - WORKSHEET - Additional Federal Agency Criteria
• HRP-319 - WORKSHEET - Limited IRB Review and Broad Consent
• HRP-320 - WORKSHEET - Scientific or Scholarly Review
• HRP-321 - WORKSHEET - Review of Information Items
• HRP-322 - WORKSHEET - Emergency Use
• HRP-323 - WORKSHEET - Criteria for Approval HUD
• HRP-324 - WORKSHEET - Contracts
• HRP-325 - WORKSHEET - Device Compassionate Use
• HRP-330 - WORKSHEET - HIPAA Authorization
• HRP-331 - WORKSHEET - FERPA Compliance
• HRP-332 - WORKSHEET - NIH GDS Institutional Certfication
• HRP-333 - WORKSHEET - Certificate of Confidentiality

400-499 CHECKLISTS

• HRP-401 - CHECKLIST - Pre-Review
• HRP-402 - CHECKLIST - Non-Committee Review
• HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process
• HRP-411 - CHECKLIST - Waiver of Written Documentation of Consent
• HRP-412 - CHECKLIST - Pregnant Women
• HRP-413 - CHECKLIST - Non-Viable Neonates
• HRP-414 - CHECKLIST - Neonates of Uncertain Viability
• HRP-415 - CHECKLIST - Prisoners
• HRP-416 - CHECKLIST - Children
• HRP-417 - CHECKLIST - Cognitively Impaired Adults
• HRP-418 - CHECKLIST - Non-Significant Risk Device
• HRP-430 - CHECKLIST - Investigator Quality Improvement Assessment
• HRP-431 - CHECKLIST - Minutes Quality Improvement Assessment
• HRP-441 - CHECKLIST - HIPAA Waiver of Authorization

• Statement of Compliance

• 000-099 SOP

• 100-199 GENERAL DOCUMENTS

• 200-299 FORMS

• 300-399 WORKSHEETS

• 400-499 CHECKLISTS

• 500-599 TEMPLATES

• 600-699 DATABASES

• 800-899 sIRB DOCUMENTS

HRP-500-599 TEMPLATE

• 500-509 GENERAL TEMPLATES
  • HRP-502 - TEMPLATE CONSENT DOCUMENT
  • HRP-503 - TEMPLATE PROTOCOL
  • HRP-503a - TEMPLATE SBS PROTOCOL
  • HRP-503b - TEMPLATE PROTOCOL - SECONDARY DATA AND SPECIMENS
  • HRP-503c - TEMPLATE PROTOCOL - SINGLE SITE SECONDARY RESEARCH
  • HRP-504 - TEMPLATE LETTER - School Permission to Conduct Research
  • HRP-505 - TEMPLATE SOP
  • HRP-506 - TEMPLATE CONSENT DOCUMENT - Emergency or Compassionate Device Use
  • HRP-507 - TEMPLATE CONSENT DOCUMENT - Short Form
  • HRP-508 - TEMPLATE SITE SUPPLEMENT TO SPONSOR PROTOCOL

• Statement of Compliance

• 000-099 SOP

• 100-199 GENERAL DOCUMENTS

• 200-299 FORMS

• 300-399 WORKSHEETS

• 400-499 CHECKLISTS

• 500-599 TEMPLATES

• 600-699 DATABASES

• 800-899 sIRB DOCUMENTS

600-699 DATABASES

800-899 sIRB DOCUMENTS

• HRP-801 - SOP - Establishing Authorization Agreements
• HRP-802 - SOP - Institutional Profile Management
• HRP-803 - SOP - Site Validation
• HRP-804 - SOP - Site Pre-Review
• HRP-805 - SOP - Site Updates
• HRP-811 - FORM - Basic Site Information
• HRP-812 - FORM - Site Continuing Review
• HRP-813 - FORM - Site Modification
• HRP-814 - FORM - Site Reportable New Information
• HRP-815 - FORM - Institutional Profile 
• HRP-817 - FORM - Reliance Request Form
• HRP-820 - WORKSHEET - Authorization Agreement Review
• HRP-830 - WORKSHEET - Communication and Responsibilities
• HRP-880 - GUIDANCE - Single IRB

Temple University Research IRB Forms