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Initial SubIRB MemberMinutes TemplateMonitor LogPatient MasterPhone RptProgress RptResponsibilitiesReview CklistReview ResultsSAESafety RptSig SheetSt Term AckSt Term NoticeTraining PlanTraining RecordTraining RequestTraining VerificationTrip Rpt EvaluationTrip Rpt InitTrip Rpt InterimTrip Rpt TerminationInitial Submission FormIRB Membership RosterIRB Meeting Minutes TemplateMonitoring LogMaster Subject LogTelephone Contact ReportIRB Progress Report FormStudy Responsibilities FormReviewer’s ChecklistIRB Review Results FormSerious Adverse ExperiencesSafety Information FormStudy Site Personnel Signature SheetIRB Study Termination AcknowledgementIRB Notification of Study Termination FormTraining Plan FormTraining Record FormStaff Training Request FormStaff Training Verification FormSite Evaluation Visit Trip ReportStudy Initiation Visit Trip ReportPeriodic Site Visit Trip ReportStudy Termination Visit Trip Report© 2004 by CRC Press LLC
Page 2: HANDBOOK OFSOPs FOR GOODCLINICAL PR
Page 10: About PolarisClinical Research Cons
Page 14: Table of ContentsMON-001.0MON-002.0
Page 20: CompanyStandard Operating Procedure
Page 24: SOP# MON-001.0CompanyEffective Date
Page 32: SOP# MON-002.0F. Retention of Train
Page 44: SOP# MON-004.0D. Template Consent F
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SOP# MON-007.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# MON-011.02. On-Site Destructio
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SOP# SITE-001.0CompanyEffective Dat
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SOP# SITE-014.0F. Records Retention
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SOP# IRB-001.0CompanyEffective Date
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SOP# IRB-002.0E. IRB SecretaryCompa
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SOP# IRB-003.0F. VotingCompanyEffec
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CompanyAdvertisement Review Checkli
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CompanyBiological Samples Inventory
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CompanyData Clarification FormCompo
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CompanyStudy Subject Investigationa
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CompanyInvestigational Drug Shippin
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CompanyDrug Return FormDrug name: S
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CompanyScreening and Enrollment Log
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CompanyInformed ConsentExpedited Re
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CompanySubject Information and Cons
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CompanyStudy Initiation Document Tr
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CompanyInitial Submission FormStudy
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CompanyInitial Submission Form (con
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CompanyIRB MEETING MINUTES TEMPLATE
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CompanyAMENDMENTSPrincipal Investig
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CompanyMonitoring LogProtocol #: In
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SubjectnumberSubject Name and Addre
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CompanyIRB Progress Report FormProt
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CompanyStudy Responsibilities FormP
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CompanyReviewer’s ChecklistProtoc
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CompanyIRB Review Results FormPropo
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Code INTENSITY as:1 = Mild2 = Moder
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CompanySerious Adverse Subject Init
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CompanySafety Information FormProto
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CompanyStudy Signature Sheet (contd
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CompanyIRB Notification of Study Te
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CompanyTraining Plan FormEmployee:S
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CompanyEmployeeProject-specific tra
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CompanyStaff Training Request FormE
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CompanySite Evaluation Visit Trip R
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CompanyOverall Assessment (continue
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CompanyMEETING CONTENTINDICATE WHIC
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CompanyPeriodic Site Visit Trip Rep
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CompanySERIOUS ADVERSE EXPERIENCESS
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CompanyStudy Termination Visit Trip
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CompanyStudy Drug (continued)Yes No
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CompanyMeeting with InvestigatorDid
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