ࡱ> tws Ybjbj 4x5#jj8$x$" $ $ $ $ $ $ $$2&(p-$-$4B$$$!!sY9SR!#X$0$!,T).T)!T)!-$-$$T)j : 91Ů Institutional Review Board (IRB) POST- IRB APPROVAL SUBMISSION REQUIREMENTS Federal regulations require ongoing study oversight by an IRB. Below is a summary of events requiring submission to the IRB after initial approval. Note: if 91Ů is acting as coordinating site or holds an IND/IDE for the study, additional reporting is required. Contact the IRB Office at 977-7744 or  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu with questions. Type of EventWhen to SubmitForm to UseReference LinksSERIOUS ADVERSE EVENTS (SAEs) OR UNANTICIPATED PROBLEMS (UPs)Internal SAE involving a death or a life-threatening experienceSubmit within 3 days of the eventSAEs or SAE/UPs: SAE Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Serious_Adverse_Event.doc"SAE Form for paper Internal UPs: Report Form in eIRB; External UPs: Amendment in eIRB; All UPs: HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol for paper HYPERLINK "http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.doc"Guidelines for Reporting Events Related to Subject Safety HYPERLINK "http://www.slu.edu/Documents/research/IRB/Instructions_4_completing_SAE.doc"Instructions for completing the SAE formOther Internal SAEs; Unanticipated Problems External UPs only require reporting if changes to the protocol are required (see Changes to Protocol section, below)Submit within 7 calendar days SAFETY ALERTS, PARTICIPANT COMPLAINTS, AUDITS, DSM REPORTS, PROTOCOL VIOLATIONS, PROTOCOL DEVIATIONS, PARTICIPANT BECOMES PRISONER/WARDSafety Alert or other information that suggests a change to a risk or benefit of the research (not deemed to be a UP)Submit within 10 working days Report Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocols HYPERLINK "http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.doc"Guidelines for Reporting Events Related to Subject Safety Serious subject complaints or those that investigators cannot resolve; data security incidents/loss of confidentialityNotify IRB in time to resolve; report form within 7 daysCall/e-mail to IRB followed by Report Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsAudit Notifications/Reports and Monitoring Reports (if report contains PV, also report as PV) ** Notify IRB prior to federal audits taking place **Audits within 10 working days; monitor reports within 30 daysReport Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocols Data Safety & Monitoring (DSM) ReportsSubmit within 10 working days of receiptAmendment Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsProtocol Violation (PV) or Protocol Deviation (PD) ** Urgent PDs can be approved by IRB via e-mail prior to official paperwork being submitted. This should be done if implementing procedures for subject safety prior to receiving IRB approval. **PD before implementing PV within 7 calendar days of becoming knownReport Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsParticipant becomes a prisoner or ward of the state during participation in the studyNotify IRB before continuing participationReport Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsCHANGES TO PROTOCOL, FINAL DSMB CHARTERS, UPDATED IBsChanges to IRB-approved Protocol, Personnel, Consents, Recruitment Materials, Questionnaires, etc; Updated Investigators Brochure (IB); Final Versions of DSMB Charter (if part of protocol) ** Amendments relating to subject safety should be submitted promptly. If new procedures must be implemented on urgent basis for subject safety, also see PD section, above. **Submit promptly. If external UP, within 7 days. Do not implement changes prior to IRB approval unless for subject safety (see PD). Amendment in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form  HYPERLINK "http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.doc"Guidelines for Reporting Events Related to Subject SafetyCONTINUING REVIEWSContinuing Reviews (CR) are required by federal regulations no less than once annually. ** Be aware of expiration date and IRB deadlines. As a courtesy, the IRB will send reminder notifications, but the PI is ultimately responsible for submitting the CR form. **  Submit at least 4-6 weeks before IRB approval expires.  Continuing Review Form in eIRB;  HYPERLINK "http://www.slu.edu/Documents/research/IRB/Continuing_Review_Form.doc" Continuing Review Form for paper protocols  NOTICE OF STUDY CLOSUREFor non-exempt protocols, submit when study is completed or will discontinue. See Reference LinkFinal Report in eIRBHYPERLINK "http://www.slu.edu/Documents/research/IRB/Study_Closure_Guidance.doc" \t "_blank"Closure of Human Research StudiesRECORD RETENTIONResearch records for studies involving human subjects must be retained for at least 3 years (6 years if HIPAA applies) after the completion of the study (closure of study). This is a federal requirement. Note: study sponsors may have additional requirements.     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