Important announcement concerning Temple Health and Keystone First. Our provider agreement with Keystone First, is scheduled to end on July 31st. Learn about your options to continue receiving care at Temple Health.
Breadcrumb
IRB Forms and SOP
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- 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
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000-999 SOPS
- 000-019 GENERAL
- 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
- 050-059 REVIEW PROCESS
- 060-069 PERIODIC TASKS
- 070-079 RECORDS
- 090-099 INVESTIGATOR
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Statement of Compliance
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000-099 SOP
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100-199 GENERAL DOCUMENTS
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200-299 FORMS
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300-399 WORKSHEETS
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400-499 CHECKLISTS
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500-599 TEMPLATES
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600-699 DATABASES
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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
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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
- 500-509 GENERAL TEMPLATES
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Statement of Compliance
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000-099 SOP
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100-199 GENERAL DOCUMENTS
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200-299 FORMS
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300-399 WORKSHEETS
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400-499 CHECKLISTS
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500-599 TEMPLATES
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600-699 DATABASES
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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
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