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Guidance

Scientific Protocol

  Scientific Protocol Template (Word Document) Guideline for Scientific Protocol

Online IRB Protocol Application Initial Submission

  Not Human Research Application MUSC Guidance HRPP Section 3.1
  Exempt Application MUSC Guidance HRPP Section 3.2
  Expedited Application MUSC Guidance HRPP Section 3.3
  Full Board Application MUSC Guidance HRPP Section 3.4

Approved Applications

  Continuing Review MUSC Guidance HRPP Section 3.5
  Amendment MUSC Guidance HRPP Section 3.6
  Protocol Deviation  
  Adverse Event MUSC Guidance HRPP Section 4.7

Attachments

  Human Research Conflict of Interest Disclosure MUSC Guidance HRPP Section 1.6
  Cover Page for Updated Investigator Brochure  
  Investigational New Drug (IND) Information Sheet (Drug A) MUSC Guidance HRPP Section 4.1
MUSC Guidance HRPP Section 4.2
  Late Submission Approval (IRB I and II Only)  
  Marketed Drug(s) Only Information Sheet (Drug B) MUSC Guidance HRPP Section 4.1
MUSC Guidance HRPP Section 4.2
  Medical device (IDE) Information Sheet (Drug D) MUSC Guidance HRPP Section 4.3
MUSC Guidance HRPP Section 4.4
  Off-Campus Study Site Off-Campus Study Site Form Word Version MUSC Guidance HRPP Section 9.1
MUSC Guidance HRPP Section 9.2
  Oncology Group NCI Protocol Only Drug Information Sheet (Drug C) MUSC Guidance HRPP Section 4.1
MUSC Guidance HRPP Section 4.2
  PI Statement of Assurance/Signature Page MUSC Guidance HRPP Section 5.1
MUSC Guidance HRPP Section 5.2
MUSC Guidance HRPP Section 5.3
  Request for Expedited Review MUSC Guidance HRPP Section 3.3

Informed Consent

  Guidelines for Standard Informed Consent MUSC Guidance HRPP Section 6.1
MUSC Guidance HRPP Section 6.2
  Guidelines for Research Involving DNA  
  Guidelines and Consent for Tissue Collection - Autopsy  
  Guidelines and Consent for Tissue Collection - Excess Surgical/Diagnostic HRPP  
  Pregnancy Test Consent, Parent  
  Pregnancy Test Consent, Minor  
  Waiver of Signed Consent  
  Waiver of Consent  

HIPAA

  HIPAA Authorization  
  HIPAA Waiver of Authorization  
  HIPAA De-Identification Form  

IRB Reviewer Checklists

  IRB Reviewer Checklist for Full Board Initial Application MUSC Guidance HRPP Section 3.4
  IRB Reviewer Checklist for Expedited Initial Application MUSC Guidance HRPP Section 3.3
  IRB Reviewer Checklist for Continuing Review Full Board and Expedited Protocols MUSC Guidance HRPP Section 3.3
MUSC Guidance HRPP Section 3.5
  IRB Reviewer Checklist Informed Consent MUSC Guidance HRPP Section 6.1
MUSC Guidance HRPP Section 6.2
  Special Subject Populations Checklist - Children MUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.5
  Special Subject Populations Checklist - Cognitively Impaired or Persons Unable to Consent MUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.2
  Special Subject Populations Checklist - Pregnant Women, Fetuses, Neonates MUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.4
  Special Subject Populations Checklist - Prisoners MUSC Guidance HRPP Section 8.1
MUSC Guidance HRPP Section 8.3

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