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SOP# MON-004.0CompanyEffective Date: DD/MMM/YYICH Guidelines for Good Clinical Practice (E6) section 1.37 – Legally AuthorizedRepresentativeICH Guidelines for Good Clinical Practice (E6) section 4.8 – Informed Consent of TrialSubjectsFDA Information Sheets – Continuing Review After Study Approval, January 2001FDA Information Sheets – Guide to Informed Consent, 1998 UpdateFDA Information Sheets – Recruiting Study Subjects, December 1999FDA Information Sheets – Screening Tests Prior to Study Enrollment, December 1999Belmont ReportDeclaration of HelsinkiV. AttachmentsNoneMON-004.0.doc© 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 18: Initial SubIRB MemberMinutes Templa
Page 22: SOP# MON-001.0CompanyEffective Date
Page 26: CompanyStandard Operating Procedure
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SOP# MON-009.0CompanyEffective 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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