Polaris

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CompanyOverall Assessment (continued) Yes No CommentSupport staff are available to study personnel if neededStudy staff agree to provide access to medical recordsDoes the site have any studies that may impact accrual?If yes, comment:Has the Investigator or any of the Subinvestigators ever beendisqualified from receiving investigational products?If yes, comment:Additional Comments/ObservationsSignature of person who conducted the visitDateTrip Rpt Evaluation.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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CompanyProtocol Amendment FormProto
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CompanyCRF Review FormProtocol #: I
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CompanyDrug Dispensing LogDrug name
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CompanyClinical Trial Materials Dis
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CompanyInvestigational Product Rece
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CompanyScreening and Enrollment Log
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CompanyExpedited Review FormStudy I
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CompanySubject Information and Cons
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CompanySubject Information and Cons
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CompanyStudy Initiation Document Tr
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CompanyInitial Submission Form (con
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CompanyIRB Membership RosterMultipl
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CompanyRecommendations (number the
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CompanyThe meeting adjourned at --:
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CompanyMaster Subject LogProtocol #
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CompanyTelephone Contact ReportDate
Page 394: CompanyIRB Progress Report Form (co
Page 398: CompanyStaff Member’s Name(Please
Page 402: CompanyReviewer’s Checklist (cont
Page 406: CompanySerious Adverse Subject Init
Page 418: CompanyStudy Site Personnel Signatu
Page 422: CompanyIRB Study Termination Acknow
Page 426: CompanySummary of SAEsSubjectInitia
Page 430: CompanyTraining Record FormEmployee
Page 434: CompanyEmployeeExternal programs (L
Page 438: CompanyStaff Training Verification
Page 442: CompanyPharmacyPharmacist name:Phar
Page 448: CompanyMEETING CONTENTINDICATE WHIC
Page 452: CompanyPeriodic Site Visit Trip Rep
Page 456: CompanySERIOUS ADVERSE EXPERIENCESS
Page 460: CompanyStudy Termination Visit Trip
Page 464: CompanyStudy Drug (continued)Yes No
Page 468: CompanyMeeting with InvestigatorDid
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