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SOP# MON-008.0CompanyEffective Date: DD/MMM/YYICH Guidelines for Good Clinical Practice (E6) section 5.1 – Quality Assurance/QualityControlV. AttachmentsAttachment A – CRF Review FormAttachment B – Data Clarification FormMON-008.0.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-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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