Polaris

SOP# IRB-005.0CompanyEffective Date: DD/MMM/YYthis case, the IRB Chairperson will send a letter to the Principal Investigator notifyinghim or her that:1. The IRB has suspended subject accrual and no new subjects can be enrolled;2. Whether or not the IRB will allow the research to continue for those subjects whoare already enrolled; and3. The Investigator must submit a Progress Report within 30 days. Failure to do sowill result in withdrawal of the approval and notification to the sponsor andregulatory agencies of the withdrawal.H. IRB Notification of Study TerminationWhen the last subject enrolled in the study has completed his/her last study-relatedassessment, the Investigator must notify the IRB about the study termination usingthe IRB Notification of Study Termination Form (Attachment E).The IRB Chairperson or Secretary will notify the rest of the IRB concerning studyterminations at the next convened meeting. Study terminations may be reviewed andpresented to the Board on an expedited basis. The IRB Chairperson will complete theIRB Study Termination Acknowledgement and send it to the Investigator todocument this notification (Attachment F).IV. References21 CFR 56.108 – IRB Functions and Operations21 CFR 56.109 – IRB Review of Research21 CFR 56.111 – Criteria for IRB Approval of Research45 CFR 46.109 – IRB Review of Research45 CFR 46.111 – Criteria for IRB Approval of ResearchICH Guidelines for Good Clinical Practice (E6) section 3.1 – ResponsibilitiesICH Guidelines for Good Clinical Practice (E6) section 4.9 – Records and ReportsICH Guidelines for Good Clinical Practice (E6) section 4.10 – Progress ReportsICH Guidelines for Good Clinical Practice (E6) section 4.12 – Premature Termination orSuspension of a TrialV. AttachmentsAttachment A – Initial Submission FormAttachment B – Reviewer’s ChecklistAttachment C – IRB Review Results FormAttachment D – IRB Progress Report FormAttachment E – IRB Notification of Study TerminationAttachment F – IRB Study Termination AcknowledgementIRB-005.0.doc© 2004 by CRC Press LLC