Sop Template for Study Initiation Visit - DOC - DOC by uyp17535


Sop Template for Study Initiation Visit document sample

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									 Good Clinical Practices SOP and                Document Control
 Template Manual                                Doc. No.: APP 034        Rev. No.: 0
                                                Date:                    Page 1 of 2


The purpose of the Site Initiation Visit is to clarify the applicable regulations and
requirements of the protocol and carefully review the actual process of implementing the
protocol at the investigational site. The Site Initiation Visit is conducted by the Sponsor
representative(s). This checklist is intended to serve as a tool for facilitating areas of
discussion, and these items should be addressed during the Site Initiation Visit.

 Investigator’s Regulatory Document File
        Signed FDA Form 1572
        Curriculum vitae for Investigator(s)
        Signed protocol and any amendments
        Investigator’s Brochure or package inserts
        IRB address and membership list (or assurance number)
        IRB approval for protocol, any amendments, and informed consent
        IRB correspondence
        General correspondence
        Study personnel signature list
        Laboratory certificate of accreditation
        Current laboratory reference ranges for all protocol-required tests
        Approval of advertisements
 Discuss In Study Overview
          Rationale for the test article development
          Background and purpose of the study
          Current finding, Investigator’s Brochure (113)
          Test article pharmacology, toxicology, and pharmacokinetics
 Discuss Good Clinical Practices and Regulatory Compliance
          Investigator obligations
          Informed consent procedures
          IRB reporting requirements
          Sponsor reporting requirements
          Study record storage requirements
          Hazmat Certification Requirements
 Review Protocol in detail
          Inclusion/exclusion criteria
          Procedures for enrolling participants
          Study treatment procedures/test article administration
          Procedures for participant withdrawals and how-to-handle lost-to-follow-up
          Special tests and procedures
Good Clinical Practices SOP and            Document Control
Template Manual                            Doc. No.: APP 034      Rev. No.: 0
                                           Date:                  Page 2 of 2

Review Adverse Event reporting
        Potential reactions
        Management of untoward effects
        Adverse event reporting requirements and procedures
        Serious adverse event reporting requirements and procedures
Review Case Report Forms (CRF)
        Instructions for completing each CRF data fields
        Typical problems and types of errors
        Correction procedures
        Submission procedures
Confirm Sponsor Preferences
        ND vs. not done vs. NA
        Blank space vs. slash
        UNK vs. unknown
        Abbreviations acceptable?
Review Laboratory Issues (when applicable)
        Procedures for ordering lab tests
        Procedures for handling specimens
        How to order supplies
        Tour of laboratory facilities
Inspect Test Article Control
        Receipt
        Storage requirements
        Accountability
        Labeling and packaging
        Dispensation procedures
        Return of test article/clinical supplies procedures
        Reordering procedures
        Decoding/breaking the blind procedures (if applicable)
Review Study Schedule
        Enrollment targets
        Monitoring schedule
        Case Reporting Form (CRF) submission deadlines
Discuss Budget Issues (if applicable)
Discuss FDA inspections and audits
Address Questions and Concerns

_______________________________________        _______________
Signature                                      Date

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