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CompanyStudy Responsibilities FormProtocolNumber:Study Title:InvestigatorName:Site Address:Sponsor:Staff Member’s Name(Please Print)DetermineIf SubjectMeetsEligibilityCriteriaIndicate which of the responsibilities below are assigned to each staff member.ObtainInformedConsentObtainMedicalHistoryPerformPhysicalExaminationsDispenseStudyDrugPerformDrugAccountabilityCollectAE/SAEData andFollow-UpEnterData inCRF orEDCSystemCorrectData inCRFsResponsibilities.doc© 2004 by CRC Press LLC
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HANDBOOK OFSOPs FOR GOODCLINICAL PR
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About PolarisClinical Research Cons
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Table of ContentsMON-001.0MON-002.0
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Initial SubIRB MemberMinutes Templa
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SOP# MON-001.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# SITE-001.0CompanyEffective Dat
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SOP# SITE-002.0F. Retention of Trai
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SOP# SITE-013.0E. Sponsor ContactsC
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SOP# SITE-014.0V. AttachmentsNoneCo
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SOP# IRB-001.0CompanyEffective Date
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CompanyProtocol Amendment FormProto
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CompanyCRF Review FormProtocol #: I
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CompanyDrug Dispensing LogDrug name
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CompanyClinical Trial Materials Dis
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CompanyInvestigational Product Rece
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CompanyScreening and Enrollment Log
Page 346: CompanyExpedited Review FormStudy I
Page 350: CompanySubject Information and Cons
Page 354: CompanySubject Information and Cons
Page 358: CompanyStudy Initiation Document Tr
Page 362: CompanyInitial Submission Form (con
Page 374: CompanyIRB Membership RosterMultipl
Page 378: CompanyRecommendations (number the
Page 382: CompanyThe meeting adjourned at --:
Page 386: CompanyMaster Subject LogProtocol #
Page 390: CompanyTelephone Contact ReportDate
Page 394: CompanyIRB Progress Report Form (co
Page 400: CompanyReviewer’s ChecklistProtoc
Page 404: CompanyIRB Review Results FormPropo
Page 408: Code INTENSITY as:1 = Mild2 = Moder
Page 412: CompanySerious Adverse Subject Init
Page 416: CompanySafety Information FormProto
Page 420: CompanyStudy Signature Sheet (contd
Page 424: CompanyIRB Notification of Study Te
Page 428: CompanyTraining Plan FormEmployee:S
Page 432: CompanyEmployeeProject-specific tra
Page 436: CompanyStaff Training Request FormE
Page 440: CompanySite Evaluation Visit Trip R
Page 444: 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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