Polaris

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CompanyInitial Submission Form (continued)Document Checklist (Please attach these documents.)ProtocolCurriculum vitae for Principal InvestigatorCopy of medical license for Principal InvestigatorForm FDA 1762, if applicableDraft consent form (dated _______; version ________)Investigator’s Brochure or package insertPatient diaries (if applicable)Copies of advertisements and all subject recruiting materials (if applicable)Initial Sub.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 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 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
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