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CompanyStudy Initiation Document Tracking Worksheet (continued)Other Study-Specific FormsDate Sent toInvestigatorDate Rec’d fromInvestigatorCommentsProtocol AmendmentSigned Amendment Signature PageRegulations (FDA, ICH)Case Report FormsStudy Procedures ManualRegulatory Documents BinderPharmacy ManualList Names of Investigator, Subinvestigators,and Study CoordinatorCV PresentMedical LicensePresentFinancialDisclosurePresentExp:Exp:Exp:Exp:Exp:Exp:Name of Lab Certifying Body Expiration date Lab NormalsInit Doc Track.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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Page 306: SOP# IRB-008.0CompanyEffective Date
Page 310: CompanyStandard Operating Procedure
Page 322: CompanyProtocol Amendment FormProto
Page 326: CompanyCRF Review FormProtocol #: I
Page 330: CompanyDrug Dispensing LogDrug name
Page 334: CompanyClinical Trial Materials Dis
Page 338: CompanyInvestigational Product Rece
Page 342: CompanyScreening and Enrollment Log
Page 346: CompanyExpedited Review FormStudy I
Page 350: CompanySubject Information and Cons
Page 354: CompanySubject Information and Cons
Page 360: CompanyInitial Submission FormStudy
Page 364: CompanyInitial Submission Form (con
Page 376: CompanyIRB MEETING MINUTES TEMPLATE
Page 380: CompanyAMENDMENTSPrincipal Investig
Page 384: CompanyMonitoring LogProtocol #: In
Page 388: SubjectnumberSubject Name and Addre
Page 392: CompanyIRB Progress Report FormProt
Page 396: CompanyStudy Responsibilities FormP
Page 400: CompanyReviewer’s ChecklistProtoc
Page 404: 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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