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CompanyScreening and Enrollment LogProtocol #: Investigator/Site #:Investigator:Sponsor:SiteAddress:Study Title:SubjectInitialsDate ofBirthDateScreenedIf Enrolled,Subject No.If Not Enrolled, Give ReasonEnrollment.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 290: SOP# IRB-006.0CompanyEffective Date
Page 298: CompanyStandard Operating Procedure
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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 344: CompanyScreening and Enrollment Log
Page 348: CompanyInformed ConsentExpedited Re
Page 352: CompanySubject Information and Cons
Page 356: CompanyStudy Initiation Document Tr
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
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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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