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Clinical Trial Inspections_How to Prevent a Bad Outcome by lhh12385


									Table of Contents
Introduction                                                                                    3

Integrated Compliance Tool                                                                      5

Linked Inspections                                                                         11

FDA Inspections                                                                            17

Inspection Closure                                                                         25

FAQs                                                                                       29

Conclusion                                                                                 33

Appendices are on the CD (located in the back of this report)
Appendix A: Guidance for Industry “E6 Good Clinical Practice: Consolidated Guidance”
Appendix B: “Guidance for Institutional Review Boards and Clinical Investigators” information
Appendix C: “Guidance for Industry Computerized Systems Used in Clinical Investigations”
Appendix D: “Concept Paper: Quality in FDA-Regulated Clinical Research: Background to
HSP/BIMO Workshop”
Appendix E: Compliance Program 7348.811: Clinical investigator
Appendix F: Compliance Program 7348.810: Sponsors, Contract Research Organization and
Appendix G: Compliance Program 7348.809: Institutional Review Board
Appendix H: Investigations Operations Manual

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