Exemption Request (IRB policy #35)

•  Exemption Request

 

Medical Records Review

• Medical Records Research Application
• Medical Records Research Renewal Form

  

Clinical Trial

New Protocol Submission (IRB policy #20, #55, #80, #85)

• New Study Checklist
• New Study Application (The New Study Application form was updated on 3/3/09 to include tables which assist the IRB in evaluating the risks & benefits to the subjects.)
• Informed Consent (IRB policy #40, #115)
• Protocol Instructions
• Signature Page
• Investigators Responsibilites Checklist a tool for your use (IRB policy #50)

Continuing Review (IRB policy #30)

• Continuing Renewal Application
• Adverse Event Summary Sheet
• Unanticipated Problem Summary Sheet

Protocl Deviations & Unanticipated Events (IRB policy #70)

• Unanticipated Problem Report
• Unanticipated Problem Summary Sheet

Adverse Events (IRB policy #60)

• Adverse Event Report
• Adverse Event Summary Sheet

Protocol Amendment or Protocol Closure (IRB policy #65)

• Amendment Change Closure Form

 

 

HIPAA FORMS (IRB policy #105)

• De-Identification Application
• Limited Data Set Use Application
• Data Use Agreement
• Researcher Certification Statement

 

Summer Science Interns (for use by high-school Summer Science Interns and their Mentors ONLY)

• Summer Interns IRB form

 

IRB Review Forms (used by the IRB members during protocol review)

• Reviewer Worksheet (IRB policy #20, #30)
• Consent Checklist (IRB policy  #40)
• Exemption Categories (IRB policy #35)
• Expedited Review Criteria (IRB policy #25)
• Advertisement Review Form (IRB policy #55)