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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
- Page 94: SOP# MON-009.0CompanyEffective Date
- Page 98: SOP# MON-009.0CompanyEffective Date
- Page 102: SOP# MON-009.0CompanyEffective Date
- Page 106: SOP# MON-009.0CompanyEffective Date
- Page 110: SOP# MON-009.0CompanyEffective Date
- Page 114: SOP# MON-010.0CompanyEffective Date
- Page 118: SOP# MON-010.0CompanyEffective Date
- Page 122: CompanyStandard Operating Procedure
- Page 126: SOP# MON-011.0CompanyEffective Date
- Page 130: CompanyStandard Operating Procedure
- Page 134: SOP# MON-012.0CompanyEffective Date
- Page 138: SOP# MON-012.0CompanyEffective Date
- Page 142: CompanyStandard Operating Procedure
- Page 148: SOP# SITE-001.0CompanyEffective Dat
- Page 152: CompanyStandard Operating Procedure
- Page 156: SOP# SITE-002.0CompanyEffective Dat
- Page 160: CompanyStandard Operating Procedure
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- Page 176: SOP# SITE-006.0CompanyEffective Dat
- Page 180: CompanyStandard Operating Procedure
- Page 184: SOP# SITE-007.0CompanyEffective Dat
- Page 188: SOP# SITE-008.0CompanyEffective Dat
- Page 192: SOP# SITE-008.0CompanyEffective Dat
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SOP# SITE-009.0CompanyEffective Dat
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SOP# SITE-009.0CompanyEffective Dat
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SOP# SITE-009.0CompanyEffective Dat
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SOP# SITE-010.0CompanyEffective Dat
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SOP# SITE-010.0CompanyEffective Dat
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SOP# SITE-011.0CompanyEffective Dat
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SOP# SITE-011.0CompanyEffective Dat
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SOP# SITE-012.0CompanyEffective Dat
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SOP# SITE-013.0CompanyEffective Dat
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SOP# SITE-013.0CompanyEffective Dat
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CompanyStandard Operating Procedure
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SOP# SITE-014.0F. Records Retention
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CompanyStandard Operating Procedure
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SOP# IRB-001.0CompanyEffective Date
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SOP# IRB-002.0CompanyEffective Date
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SOP# IRB-002.0E. IRB SecretaryCompa
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SOP# IRB-002.0CompanyEffective Date
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SOP# IRB-003.0CompanyEffective Date
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SOP# IRB-003.0F. VotingCompanyEffec
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CompanyStandard Operating Procedure
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SOP# IRB-004.0CompanyEffective Date
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SOP# IRB-005.0CompanyEffective Date
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SOP# IRB-005.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# IRB-006.0CompanyEffective Date
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SOP# IRB-006.0CompanyEffective Date
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SOP# IRB-007.0CompanyEffective Date
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CompanyStandard Operating Procedure
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SOP# IRB-008.0CompanyEffective Date
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SOP# IRB-009.0CompanyEffective Date
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SOP# IRB-009.0CompanyEffective Date
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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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CompanyInitial Submission Form (con
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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