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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# MON-002.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# MON-003.0CompanyEffective Date
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SOP# MON-004.0CompanyEffective Date
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SOP# MON-004.0CompanyEffective Date
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SOP# MON-005.0CompanyEffective Date
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SOP# MON-005.0CompanyEffective Date
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SOP# MON-006.0CompanyEffective Date
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SOP# MON-006.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# MON-007.0CompanyEffective Date
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SOP# MON-007.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# MON-008.0CompanyEffective Date
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SOP# MON-008.0CompanyEffective Date
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SOP# MON-009.0CompanyEffective Date
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SOP# MON-009.0CompanyEffective Date
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SOP# MON-009.0CompanyEffective Date
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SOP# MON-009.0CompanyEffective Date
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SOP# MON-009.0CompanyEffective Date
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SOP# MON-009.0CompanyEffective Date
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SOP# MON-010.0CompanyEffective Date
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SOP# MON-010.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# MON-011.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# MON-012.0CompanyEffective Date
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SOP# MON-012.0CompanyEffective Date
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CompanyStandard Operating Procedure
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CompanyStandard Operating Procedure
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SOP# SITE-001.0CompanyEffective Dat
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SOP# SITE-002.0CompanyEffective Dat
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SOP# SITE-002.0F. Retention of Trai
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SOP# SITE-003.0CompanyEffective Dat
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SOP# SITE-004.0CompanyEffective Dat
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SOP# SITE-005.0CompanyEffective Dat
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SOP# SITE-006.0CompanyEffective Dat
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SOP# SITE-006.0CompanyEffective Dat
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SOP# SITE-007.0CompanyEffective Dat
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CompanyStandard Operating Procedure
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SOP# SITE-008.0CompanyEffective Dat
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CompanyStandard Operating Procedure
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SOP# SITE-009.0CompanyEffective Dat
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SOP# SITE-009.0CompanyEffective Dat
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CompanyStandard Operating Procedure
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SOP# SITE-010.0CompanyEffective Dat
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CompanyStandard Operating Procedure
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SOP# SITE-011.0CompanyEffective Dat
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CompanyStandard Operating Procedure
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CompanyStandard Operating Procedure
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SOP# SITE-013.0CompanyEffective Dat
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SOP# SITE-013.0E. Sponsor ContactsC
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SOP# SITE-014.0CompanyEffective Dat
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SOP# SITE-014.0V. AttachmentsNoneCo
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SOP# IRB-001.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# IRB-002.0CompanyEffective Date
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SOP# IRB-002.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# IRB-003.0CompanyEffective Date
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SOP# IRB-003.0CompanyEffective Date
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SOP# IRB-004.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# IRB-005.0CompanyEffective Date
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SOP# IRB-005.0CompanyEffective Date
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SOP# IRB-006.0CompanyEffective Date
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SOP# IRB-006.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# IRB-007.0CompanyEffective Date
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SOP# IRB-008.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# IRB-009.0CompanyEffective Date
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SOP# IRB-009.0CompanyEffective Date
- 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 358: CompanyStudy Initiation Document Tr
- Page 362: CompanyInitial Submission Form (con
- Page 366: CompanyInitial Submission Form (con
- Page 370: 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
- 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
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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