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CompanySummary of SAEsSubjectInitialsSubjectNumberSAEOutcome of theSAESummary of GCP ViolationsSubjectInitialsSubjectNumberGCP ViolationIf you have any questions concerning the information in this report, please contact me at (phonenumber) ___________________.Principal Investigator (print) Investigator’s Signature DateSt Term Notice.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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Page 374: CompanyIRB Membership RosterMultipl
Page 378: CompanyRecommendations (number the
Page 382: CompanyThe meeting adjourned at --:
Page 386: CompanyMaster Subject LogProtocol #
Page 390: 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 428: CompanyTraining Plan FormEmployee:S
Page 432: CompanyEmployeeProject-specific tra
Page 436: CompanyStaff Training Request FormE
Page 440: CompanySite Evaluation Visit Trip R
Page 444: CompanyOverall Assessment (continue
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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