Checklist of Required Process Steps

							                       CHECKLIST OF REQUIRED PROCESS STEPS

   Consultation Process (if applicable)
         PI/CRA submits consultation request
         Program Coordinator puts request in queue
         Analyst pulls consult request from queue
         Analyst provides PI/CRA w/consultation
         Analyst sends PI/CRA educational/guidance materials via e-mail

   New Full-Review Application Process
         PI/CRA submits new application materials
         Program Coordinator reviews for submission standards
                Submission Standards met?
            If Yes:        Program Coordinator puts application materials in queue to review
            If No:        Program Coordinator sends submission standards memo highlighting
                           what’s missing to PI/CRA; process starts over
         Analyst pulls application materials
         Analyst reviews application materials
                IRB Review Acceptance Standards met?
            If Yes:        Program Coordinator sends PI/CRA IRB meeting invite
            If No:        Application materials sent back to PI/CRA and consultation scheduled if
                           appropriate; process starts over
                               Consultation takes place if appropriate
         IRB Member reviews documents on E-review
                If clarification is needed, IRB Member contacts PI/CRA
         Attend IRB Meeting
                Study receives final approval?
            If Yes:        Letter & Study docs prepared and sent to PI/CRA
            If No:        Study approved with contingencies and letter sent to PI/CRA
                           PI/CRA makes changes in response and sends back to the analyst
                               Study receives final approval?
                                    If Yes:    Letter & Study docs prepared and sent to PI/CRA
                                    If No:    IRB Chair may refer study back to full IRB for review
         Final Study Approval




Checklist of Required Process Steps                                                       7/16/2012
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