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BL
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| Record Number
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1020326
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| Doc. No
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b774696
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| Main Entry
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Rosenbaum, Deborah.
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| Title & Author
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Physician investigator handbook : : GCP tools and techniques /\ Deborah Rosenbaum, Fred Smith.
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| Edition Statement
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2nd ed.
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| Publication Statement
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Englewood, CO :: IHS Health Group,, ©2001.
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| Series Statement
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Practical clinical trials series
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| Page. NO
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1 online resource (x, 471 pages (loose-leaf)) :: illustrations
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| ISBN
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0429134215
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: 1420025937
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: 1574911244
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: 9780429134210
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: 9781420025934
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: 9781574911244
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1574911244
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Front Cover; Contents; Introduction; Chapter 1: Overview and Elements of Clinical Research; General Goals; Who Conducts Clinical Research?; The Drug Development Process; Phases of Clinical Research; Basic Elements of Clinical Research; Resources; Bibliography; Chapter 2: The Physician as Investigator; Qualifications of the Principal Investigator; The Investigative Staff; Subinvestigators; The Role of the Clinical Research Coordinator in Clinical Research; Support Staff: Administrative, Pharmacy, and Hospital; The Study Work Area; Investigator Responsibilities to the Institutional Review Board.
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Financial Disclosure by Clinical InvestigatorsElectronic Signature (21 CFR 11); The Institutional Review Board; Subject Informed Consent; Regulatory References; Contacts; Bibliography; Chapter 5: Investigational Agent Management; Investigational Drug Agents in a Clinical Trial; Packaging of Investigational Agent; Study Drug Labels; Receiving and Storing the Investigational Agent; Dispensing the Investigational Drug Agent; Instructions to Study Subjects; Study Drug Accountability; Code Breakers; Destruction of the Investigational Agent-Final Disposition; Common Questions; Regulatory References.
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Informed ConsentRecordkeeping Responsibilities; Supervisory Responsibilities; Bibliography; Chapter 3: Professional Interactions; The Institutional Review Board; Pharmacy; Laboratories and Medical Imaging; Emergency Room (ER) and Intensive Care Unit (ICU); Communication Strategies; Study Coordination; Preparing Hospital Staff; Bibliography; Chapter 4: FDA Regulations and Good Clinical Practice Guidelines; Code of Federal Regulations; ICH GCP Guideline; Responsibilities of the Investigator; Responsibilities of the Sponsor; Sponsor Investigator Status.
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The Planning Stage of a StudyStudy Commencement; Keeping Up with the Study; Study Termination; Regulatory Reference; Bibliography; Chapter 9: Monitoring of Clinical Trials; Site Monitoring Visits; Grant-Sponsored Visits (Audits and Inspections); Resolution of Problems Identified at Site Visits; Telephone Monitoring; Written Correspondence; Investigator's Meetings; Study Procedures Manual; Bibliography; Chapter 10: Interactions with the Study Subject; Subject Recruiting; Subject Screening; Subject Enrollment; Subject Retention; Bibliography; Chapter 11: Adverse Events and Drug Safety.
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| Abstract
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A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The chapters address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent managemen.
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| Subject
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Clinical trials-- Law and legislation-- United States.
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Clinical trials.
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Drugs-- Testing-- Law and legislation-- United States.
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| Subject
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Drugs-- Testing-- Standards.
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| Subject
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Clinical trials-- Law and legislation.
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Clinical trials.
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Drugs-- Testing-- Law and legislation.
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Drugs-- Testing-- Standards.
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| Subject
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MEDICAL-- Research.
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Clinical Trials as Topic-- standards.
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| Subject
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Clinical Trials as Topic-- methods.
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| Subject
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Physicians.
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| Subject
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United States.
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| Dewey Classification
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610/.72
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| LC Classification
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R853.C55R675 2001eb
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| NLM classification
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2002 N-629
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QV 771R813p 2001
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| Added Entry
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Smith, Fred, (Fred O.)
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