LEADER 05307nam 2200649 a 450 001 9910140166103321 005 20230725023056.0 010 $a0-470-92088-2 010 $a1-283-02484-5 010 $a9786613024848 010 $a0-470-57275-2 010 $a0-470-57274-4 035 $a(CKB)2580000000004818 035 $a(EBL)624561 035 $a(OCoLC)710972876 035 $a(SSID)ssj0000483390 035 $a(PQKBManifestationID)11337976 035 $a(PQKBTitleCode)TC0000483390 035 $a(PQKBWorkID)10529156 035 $a(PQKB)11068736 035 $a(MiAaPQ)EBC624561 035 $a(Au-PeEL)EBL624561 035 $a(CaPaEBR)ebr10452951 035 $a(CaONFJC)MIL302484 035 $a(EXLCZ)992580000000004818 100 $a20090707d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aClinical trials audit preparation$b[electronic resource] $ea guide for good clinical practice (GCP) inspections /$fVera Mihajlovic-Madzarevic 210 $aHoboken, N.J. $cJohn Wiley$d2010 215 $a1 online resource (270 p.) 300 $aDescription based upon print version of record. 311 $a0-470-24885-8 320 $aIncludes bibliographical references and index. 327 $aCLINICAL TRIALSAUDIT PREPARATION; CONTENTS; PREFACE; INTRODUCTION; Background History on Clinical Research Standards; GLOSSARY; CHAPTER 1 GOOD CLINICAL PRACTICE AND THERAPEUTIC PRODUCT DEVELOPMENT; 1.1 Good Clinical Practice in Clinical Research; 1.1.1 Definition; 1.1.2 GCP Compliance; 1.1.3 GCP Objectives; 1.1.4 Principles of ICH GCP; Clinical Trial Conduct; Risk Assessment; Subject's Rights and Safety; Background Information; Clinical Trial Protocol; Ethics Review and Approval; Medical Care of Trial Subject; Qualifications of Clinical Trial Personnel; Informed Consent Process 327 $aData ManagementPatient Confidentiality; Investigational Product Manufacturing, Handling, and Storage; Quality Assurance; 1.1.5 GCP Applicability; 1.2 Role of the Sponsor of a Clinical Investigation; 1.2.1 GCP: Responsibilities of a Sponsor of a Clinical Trial; 1.2.2 Essential Documents for the Clinical Trial; Retention of the Essential Documents for the Clinical Trial; Archiving of the Essential Documents for the Clinical Trial After Discontinuation of Development; Notification; Transfer of Data Ownership; Records Retention; 1.2.3 Investigator Selection; Investigator's Qualifications 327 $aResources at the Investigator's SiteProtocol and Investigator's Brochure; Agreement with the Investigator/Institution; 1.2.4 Allocation of Responsibilities; 1.2.5 Compensation to Subjects and Investigators; Compensation to Subjects for Trial-Related Injuries; Other types of Compensation to Trial Subjects; 1.2.6 Financing; 1.2.7 Notification/Submission to Regulatory Authorities; 1.2.8 Confirmation of Review by IRB/IEC; 1.2.9 Information on Investigational Products; 1.2.10 Manufacturing, Packaging, Labelling, and Coding Investigational Products 327 $aCharacterization, Manufacturing, and Labeling of the Investigational ProductStorage Conditions; Packaging of the Investigational Product; Coding and Decoding of the Investigational Product; Investigational Product Changes and Bioequivalence Studies; 1.2.11 Supplying and Handling Investigational Products; Supply; Investigational Product Records; 1.2.12 Record Access; Verification of Patient Consent to Record Access; 1.2.13 Safety Information; Safety Issues; Communication of Safety Issues; 1.2.14 Adverse Drug Reaction Reporting; Serious Unexpected Adverse Drug Reactions 327 $aSAE Reporting ComplianceSafety Updates and Periodic Reports; 1.2.15 Monitoring; Purposes; Selection and Qualifications of Monitors; Monitoring Strategies; Monitor's Responsibilities; Monitoring Procedures; Monitoring Report; 1.2.16 Audit; Selection and Qualifications of Auditors; Auditing Procedures; Site Selection Criteria for Inspection; Reporting of Findings; Audit Certificate; 1.2.17 Noncompliance; 1.2.18 Premature Termination or Suspension of a Trial; 1.2.19 Clinical Trial/Study Reports; 1.2.20 Multicenter Trials 327 $a1.3 Role of the Institutional Review Board/Independent Ethics Committee (IRB/IEC) 330 $aA must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investig 606 $aDrugs$xTesting$xAuditing 606 $aMedical audit 615 0$aDrugs$xTesting$xAuditing. 615 0$aMedical audit. 676 $a615.5/80724 700 $aMihajlovic-Madzarevic$b Vera$0971870 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910140166103321 996 $aClinical trials audit preparation$92209620 997 $aUNINA