Audit Prep Workshop 6.07,P&P.PPT

CALGB DATA AUDITPolicies and ProceduresSusan Tuttle, R.N.Audit Committee Vice-ChairCALGB Audit Preparation Workshop, November 2008CALGB Audit Committee For CALGB Participants Only Slide 3ÊÊÊÊÊÊRegulatory ComplianceIRB review/approval required before entryAnnual review at least every 12 months or <365 daysAll updates reviewed as required within 90 days of implementation/distributionCALGB Audit Committee For CALGB Participants Only Slide 5Regulatory ComplianceBroadcast SAEs submitted to IRB within 90 days of distribution UNLESS institution has policy/SOPs for handling differently than within 90 daysAction Letters acknowledged by IRB within 90 days of distributionAudit update and broadcast SAE list on web (resources → audit)CALGB Audit Committee For CALGB Participants Only Slide 6ÊÊÊÊRegulatory ComplianceParticipant notification accomplished as indicatedIRB informed of local AEs and appropriate reporting of serious Adverse Events reported to NCI via AdEERSCALGB Audit Committee For CALGB Participants Only Slide 7Regulatory ComplianceAdditional ReviewsCompanion studies Closed studies with patients still being followed – Expedited versus Full BoardCALGB Audit Committee For CALGB Participants Only Slide 8ÊÊÊÊRegulatory ComplianceSuspension of local enrollment due to new or modified risk information (i.e., 40302)The Central Office will indicate on update cover page when local suspension of enrollment is required ...