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Coeus Premium - IRB Protocol

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 bulletProtocol Documents

Coeus Document Type Uploaded Document
Study Description
  • Application to Use Human Research Subjects (FUTUR: Non-Exempt Protocol Application Form)
  • Exemption Request – Category 1
  • Exemption Request – Category 2 & 3b
  • Exemption Request – Category  4
  • Exemption Request – Category 6b
Continuing Review Application Continuing Review Form
Consent Documents
  • Research Participant Consent Form (Participant & Parental)
  • Sample Assent Form
  • Assent Scripts
  • Authorization for Research or Use of Protected Health Information for Research Purposes
  • Information Sheet
Appendices
  • Appendix A – Data Repositories
  • Appendix B – Deception Form
  • Appendix C – Use of Devices in Research
  • Appendix D – Use of Drugs or Biologics in Research
  • Appendix E – Storage, Collection, and Use of Biological Materials (Repository)
  • Appendix F – Children in Research
  • Appendix G – International Research
  • Appendix H – Pregnant Women/Fetuses /Neonates
  • Appendix I  - Prisoners
  • Appendix J1 – Waiver or Alteration of Consent
  • Appendix J2 – Waiver of Documentation of Signed Consent
  • Appendix K – Request for IRB Waiver of HIPAA Authorization
  • Certification of Compliance with HIPAA Privacy Rule for Research Involving Decedent’s Information Only
  • Activities Preparatory to Research – Request for Waiver of Authorization

Recruitment Materials

(INVESTIGATOR GENERATED)

  •  
    • Advertisements
    • Flyers
    • Letters
    • Scripts
    • Emails

Correspondences

(INVESTIGATOR GENERATED)

  • All Email Communications
  • All Written Communications

Study Instruments/Surveys/Questionnaires

(INVESTIGATOR GENERATED)

  • Study Instruments
  • Surveys
  • Questionnaires
Other Documents
  • Unanticipated Problems Form (INTERIM ONLY)
  • Protocol Amendment (INTERIM ONLY)
  • Grant Proposal

 

 bulletIRB Admin Documents

Coeus Document Type Uploaded Document
IRB Consent Documents
IRB Acknowledgements
IRB Correspondences
IRB Other