FCCC HRPP Toolkit

Statement of Compliance

• 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 Informationx
  • 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
• 040-049 COMMITTEE REVIEW
  • HRP-040 - SOP - IRB Meeting Preparation
  • HRP-041 - SOP - IRB Meeting Conduct
  • HRP-042 - SOP - IRB Meeting Attendance Monitoring
  • HRP-043 - SOP - IRB Meeting Minutes
  • HRP-044 - SOP - Not Otherwise Approvable Research
• 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
• 080-089 COMMITTEE MANAGEMENT
  • HRP-080 - SOP - IRB Formation
  • HRP-081 - SOP - IRB Removal
  • HRP-082 - SOP - IRB Membership Addition
  • HRP-083 - SOP - IRB Membership Removal
  • HRP-084 - SOP - IRB Meeting Scheduling and Notification
• 090-099 INVESTIGATOR
  • HRP-090 - SOP - Informed Consent Process for Research
  • HRP-091 - SOP - Written Documentation of Consent

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

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

HRP-500-599 TEMPLATES

• 501-509 GENERAL TEMPLATES
  • HRP-500 - TEMPLATE BROAD CONSENT DOCUMENT
  • HRP-501 - TEMPLATE MINUTES
  • HRP-502 - TEMPLATE CONSENT DOCUMENT
  • HRP-503 - TEMPLATE PROTOCOL
  • HRP-503a - TEMPLATE SBS PROTOCOL
  • 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
• 510-529 LETTERS - POST REVIEW
  • HRP-510 - LETTER - Approval
  • HRP-511 - LETTER - Closure
  • HRP-512 - LETTER - Mods Req to Secure Approval
  • HRP-513 - LETTER - NHR Determination
  • HRP-514 - LETTER - Exemption
  • HRP-515 - LETTER - Suspension or Termination
  • HRP-516 - LETTER - Deferral
  • HRP-517 - LETTER - Disapproval
  • HRP-518 - LETTER - Tabled
  • HRP-519 - LETTER - Information Item
  • HRP-520 - LETTER - External Report
  • HRP-521 - LETTER - SR NSR Device
  • HRP-522 - LETTER - Cert Prisoner Research
  • HRP-523 - LETTER - Not Otherwise Appro Research
  • HRP-524 - LETTER - Ack Personnel Update
  • HRP-526 - TEMPLATE LETTER - External Report to DOD
  • HRP-528 - LETTER - NIH GDS Institutional Certification
  • HRP-529 - LETTER - AAHRPP Notice of Information Item
• 530-539 LETTERS - REMINDERS
  • HRP-530 - LETTER - Continuing Review Reminder
  • HRP-531 - LETTER - Training Reminder
  • HRP-532 - LETTER - Conti Subj Expired Research
  • HRP-533 - LETTER - Expiration of IRB Approval
  • HRP-534 - LETTER - Investigator QI Assessment
  • HRP-535 - LETTER - Annual Reminder
• 540-549 LETTERS - IRB REVIEW
  • HRP-540 - LETTER - Designated Reviewer Materials
  • HRP-541 - LETTER - IRB Member Review Materials
• 550-559 LETTERS - FAILURE NOTIFICATIONS
  • HRP-550 - LETTER - Failure to Submit CR
  • HRP-551 - LETTER - Failure to Submit EU Report
  • HRP-553 - LETTER - Failure to Submit EU Protocol
  • HRP-554 - LETTER - Failure to Undergo Training
• 560-569 LETTERS - COMMITTEE MANAGEMENT
  • HRP-560 - LETTER - IRB Appointment
  • HRP-561 - LETTER - IRB Thank You
  • HRP-562 - LETTER - IRB Appreciation
• 570-579 LETTERS - EMERGENCY USE
  • HRP-570 - LETTER - Pre-Rev EU - Crit Met
  • HRP-571 - LETTER - Pre-Rev EU - Crit Not Met
  • HRP-572 - LETTER - Review of EU - Crit Met
  • HRP-573 - LETTER - Review of EU - Crit Not Met

600-699 DATABASES

• HRP-601 - DATABASE - IRB Roster.xlsx

HRP-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-830 - WORKSHEET - Communication and Responsibilities
• HRP-851 - LETTER - Invitation Decision
• HRP-857 - LETTER - Acknowledge External IRB
• HRP-859 - LETTER - Acknowledge External IRB Update
• HRP-861 - WORKBOOK - Institutional Profiles.xlsm
• HRP-870 - LETTER - Site Approval
• HRP-872 - LETTER - Site Modifications Requred to Secure Approval
• HRP-876 - LETTER - Site Deferral
• HRP-877 - LETTER - Site Disapproval
• HRP-879 - LETTER - Review of Site Information Item

HRP-900-999 OTHER DOCUMENTS

• HRP-900 - BROCHURE - Should I Take Part in Research.tu.docx 
• HRP-901 - Investigator Self-Assessment.docx 
• HRP-902 - Investigator Self-Assessment Instructions.docx 
• HRP-903 - Investigator Satisfaction Survey.pdf
• HRP-910 - Investigator Manual.tu.docx