IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office.

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IRB 7.2 IRB MEMBER TRAININGPresented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research OfficeLOCATING CHECKLISTSSeveral worksheets and checklists are provided in the system to guide your review process and document your decisions. Worksheets are for the reviewer's benefit only.Checklists must be completed and attached when submitting your review comments to document your decisions.To locate the worksheets and checklists:Click IRB then IRB library in upper left corner.Click the Worksheets or Checklists tab.Click a link to open or save the document.IRB 7 NAVIGATIONMY INBOXUNDERSTANDING YOUR INBOXYour RoleIn My InboxNot In My InboxStateExplanationIRBcommitteemember oroccasionalreviewerNon-committee ReviewYou have been designated as the reviewer for this exempt or expedited study. You must submit your final review before the IRB decision can be communicated to the study team. If you request clarifications, the study comes back to you to finish the review after the clarifications are made.Studiesassigned tootherreviewersCommittee ReviewYou may be part of the committee that will review this study. If so, review the study details in advance. You can request clarifications. Record your notes and recommendations in the system before the meeting as described in Preparing Comments for a Meeting.Studiesassigned toothercommitteesTHE STUDY WORKSPACEIRB MEETING AGENDASLOCATING MEETING AGENDA ITEMSAs a committee member, you can get a meeting agenda listing the studies and other submissions to be reviewed in an upcoming meeting. You can get the agenda in two forms:As a web page with links to the studiesAs a printable documentACCESSING AGENDA FROM E-MAILTo access the meeting workspace web page containing links to the studies, click the link next to Link.To open or save the printable document, click the link next to Description.Note: The most up-to-date agenda is in the web page format.NAVIGATING TO THE AGENDAClick IRB and then IRB Meetings in the upper left corner.Click the name of the meeting to view.The meeting workspace displays the list of agenda items in the center of the page.IRB COMMITTEE MEETING AGENDACHECKLISTS AND WORKSHEETSLOCATING CHECKLISTSSeveral worksheets and checklists are provided in the system to guide your review process and document your decisions. Worksheets are for the reviewer's benefit only.Checklists must be completed and attached when submitting your review comments to document your decisions.To locate the worksheets and checklists:Click IRB then IRB library in upper left corner.Click the Worksheets or Checklists tab.Click a link to open or save the document.KEY CHECKLISTS AND WORKSHEETSTopicChecklists (use and attach)Worksheets (for reviewer's use)Approval CriteriaCriteria for Approval and Additional Considerations (HRP-314)Additional Federal Criteria (HRP-318)Type of ReviewPre-Review (HRP-308)Review of Information Items (HRP-321)Scientific or Scholarly Review (HRP-320)Level of ReviewHuman Research (HRP-310)Engagement (HRP-311)Exemption (HRP-312)Expedited (HRP-313)KEY CHECKLISTS AND WORKSHEETSTopicChecklists (use and attach)Worksheets (for reviewer's use)Consent /recruitmentWaiver or Alteration of Consent (HRP-410)Waiver of Written Documentation ofConsent (HRP-411)Waiver of Consent for Emergency Research (HRP-419)HIPAA Waiver of Authorization (HRP-441)Short Form of Consent (HRP-317)Advertisements (HRP-315)Payments (HRP-316)Special PopulationsPregnant Women (HRP-412)Non-Viable Neonates (HRP-413)Neonates of Uncertain Viability (HRP-414)Prisoners (HRP-415)Children (HRP-416)Cognitively Impaired Adults (HRP-417)KEY CHECKLISTS AND WORKSHEETSTopicChecklists (use and attach)Worksheets (for reviewer's use)Devices/DrugsNon-Significant Risk Device (FDA) (HRP-418)Drugs (HRP-306)Devices (HRP-307)Criteria for HUD Approval andAdditional Considerations (HRP-323)Emergency Use (HRP-322)Type of ReviewHIPAA Waiver of Authorization (HRP-441)Additional Federal Criteria (HRP-318)HIPAA Authorization (HRP-330)THE NEW STUDY APPLICATIONTitle as listed in protocolAbbreviated title for easy identificationSummary of studySelect PI from a list of IRB7 usersDisclosures should be consistent with disclosures in DPSUnless prior permission is granted, answer should be NoSponsors protocol should be uploaded here. For investigator-initiated research, use the protocol template to develop protocolA list of known funding sources/sponsors will be available. Contact the HSRO if a new source needs to be added. Upload grant application or draft CTA as appropriateStandard study teams may be associated with a PI. Please review to ensure that the study team members listed here are accurateAnswer yes only if the UM PI is responsible for the conduct of this study at external sitesUsed for branchingUsed for branchingList drugs, combinations, etc., to be studied Investigator Brochures should be included here as wellList as appropriateUpload IND letter or other correspondence from the FDA*This page will only appear if yes is selected in question 2 on the Study Scope pageCheck yes if appropriate*This page will only appear if yes is selected in question 3 on the Study Scope pageList devices to be studied Any documentation, instructions, etc. associated with the use of the device would be uploaded here as wellCheck appropriate radio buttonList as appropriateUpload IDE letter or other correspondence from the FDAUpload ICF and other documents to be used during consent processUpload advertisements, flyers, patient letters and other documents to be used for recruitmentUpload any other documents not already includedNOTE: Clicking Finish does not submit the study. The PI must log in and click on the submit study link. NOTE: Only the PI may submit the study.THE MODIFICATION/ CONTINUING REVIEW FORMSelect type of submissionNOTE: This question will not appear if Continuing Review is selected aboveNumbers reported here must be consistent with prior reports and, if applicable, VelosIndicate current state of the studyIf a COI was disclosed at initial submission, or there are no COIs, select NoSelect all that applyExamples: enrollment summaries, summaries of AEs not requiring immediate reporting, summaries of deviations not requiring immediate reporting, DSMB reports, grant progress reports, sponsor letters re: enrollment, etc.Indicate current state of studyIndicate whether PI intends to notify subjectsList any changes that are UM-specificStudy-wide modifications that are described in a sponsors amendment do not need to be included here. Study teams may simply state Refer to sponsors summary of changes (or other appropriate document)NOTE: Clicking Finish does not submit the continuing review/modification. The PI must log in and click on the submit link. NOTE: Only the PI may submit the continuing review/modification.THE REPORTABLE NEW INFORMATION FORMWhen viewing items in your Inbox or on the IRB Workspace, RNI Short Title will show up under the Name columnList date study team became aware of the RNIRNI includes unanticipated problems, newly identified risks, adverse events (unexpected and probably related), deviations and violations, audit or monitoring results, etc.RNIs do not include expected or unrelated AEs, IND Safety Reports, Translations, Sponsor Letters without impact on risks, etc.Summary of RNISelect Yes or No based on PIs review of the RNIYou will be able to list as many studies as are affected. (E.g. PI is involved in multiple studies involving the same drug.)Upload documents as appropriateCOMPLETING YOUR REVIEWTO COMPLETE A DESIGNATED (OR NON-COMMITTEE) REVIEW:Click Submit Designated ReviewIf true, check the box to indicate that you do not have a conflicting interestAnswer the relevant questions, paying special attention to each required question marked with a red asterisk (*).(Optional) Add comments and attach documents related to the reviewTO COMPLETE A COMMITTEE REVIEW:Click Submit Committee ReviewAnswer the relevant questions, paying special attention to each required question marked with a red asterisk (*).(Optional) Add notes and attach documents related to the committee's review.Click OK.THANK YOU!Joey Casanova, CIP Associate Director for Educational Initiatives jcasanova@med.miami.edu305-243-9232

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