Completed before IRB Review

• Branch or Section Review
• Institute Scientific Review
• Statistical Review (if required by institute)
• Pre-IRB Review by IRB Staff

     Completed Concurrent with IRB Review

• Ethics Review for financial conflict of interest (DEC Review)
• Resource Utilization Review (PRIA form)
• FDA Review
• Radiation Safety Committee or Radioactive Drug Research Committee Review
• Review by Collaborating Sites (Collaborating Site IRB Approval Documentation)
• Review by Recombinant DNA Advisory Committee and/or Institutional Biosafety Committee

     IRB Review Process

• Expedited or Full Board IRB Review
• IRB Actions
• Response to IRB Stipulations
• Final Sign Off

     Completed After IRB Review

• Office of Protocol Services Review
• Director, Clinical Center Review

      Submission Types

• Initial Review
• Continuing Review
• Amendment
• Problem Reports

  - Serious Adverse Event

  - Protocol Deviation

  - Unanticipated Problem

  - Investigator non-compliance

• Study Closure
• Others