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Foreword; Preface; Contents; Part I: Laws, Standards and Guidelines; 1: The Road toßExcellence: AßCase Study ofßtheßApplication ofßGMP, ISO 9001 andßtheßEFQM Excellence Model inßaßNuclear Medicine Department; 1.1 Introduction toßQuality andßExcellence; 1.2 Quality Definitions andßStandards inßQuality Management; 1.2.1 Quality Definitions; 1.2.1.1 Quality; 1.2.1.2 Quality inßHealth Care; 1.2.1.3 Quality Management; 1.2.2 Standards andßModels; 1.2.2.1 Good Manufacturing Practice (GMP) (De Vos etßal. 2005); 1.2.2.2 Good Clinical Practice (GCP).
1.2.2.3 ISO 9000 Family ofßQuality Management Systems Standards andßISO 90011.2.2.4 EFQM Excellence Model; 1.3 Quality Management at NMMI inßUMCG; 1.3.1 The Evolving Role ofßtheßQuality Management System; 1.3.2 What Has ISO 9001 Brought?; 1.3.3 How EFQM Brought NMMI Further AlongßtheßRoad toßExcellence; References; Internet Sources; 2: Good Clinical Practices inß(Nuclear) Research; 2.1 Origin ofßtheßGCP Regulations; 2.1.1 Nuremberg Code; 2.1.2 Declaration ofßHelsinki ; 2.1.3 The Development ofßtheßGood Clinical Practice Guideline.
2.1.4 Conducting aßClinical Study inßCompliance withßGCP2.1.4.1 Phases; 2.2 The Independent Ethics Committee (IEC) or Institutional Review Board (IRB); 2.2.1 Necessary Documents; 2.2.2 Approval ofßaßStudy Proposal; 2.2.3 Content ofßanßIEC Approval Letter; 2.2.4 Progress Reporting; 2.2.5 Composition andßFunctioning ofßanßIndependent Ethics Committee; 2.3 The Investigator; 2.3.1 Qualifications ofßanßInvestigator; 2.3.2 Facilities Needed toßQualify forßaßGCP Study; 2.3.3 Emergency Care; 2.3.4 Communicating withßtheßIEC/IRB.
2.3.5 Is Compliance toßtheßStudy Protocol Required According toßICH GCP?2.3.6 Investigational Medicinal Product; 2.3.6.1 What Is Required forßInvestigational Medicinal Products (IMPs)?; 2.3.6.2 Should theßInvestigator Comply withßtheßRandomization Procedure andßUnder Which Circumstances Should theßInvestigator Break theßStudy Code inßaßDouble-Blind Study?; 2.3.7 Informed Consent Procedure; 2.3.8 Nontherapeutic Trials; 2.3.8.1 Informed Consent forßLegally Restraint Subjects; 2.3.9 Records andßReporting Requirements; 2.3.9.1 Progress Reporting; 2.3.10 Safety Reporting.
2.3.10.1 Annual Safety Reporting2.3.10.2 Premature Temporarily or Final Stop ofßtheßStudy; 2.4 The Sponsor; 2.4.1 Delegation toßaßContract Research Organization (CRO)?; 2.4.2 Arrangements forßTrial Management, Data Handling, andßRecord Keeping; 2.4.3 Investigational Medicinal Products (IMPs) andßtheßTasks ofßtheßSponsor; 2.4.4 What Should theßSponsor Do toßEnsure Direct Access inßtheßMedical Files ofßtheßSubjects?; 2.4.5 Which Safety Information ofßtheßIMP Should BeßMade Available byßtheßSponsor?; 2.4.6 Reporting ofßAdverse Drug Reactions; 2.4.6.1 Adverse Event (AE).
1.2.2.3 ISO 9000 Family ofßQuality Management Systems Standards andßISO 90011.2.2.4 EFQM Excellence Model; 1.3 Quality Management at NMMI inßUMCG; 1.3.1 The Evolving Role ofßtheßQuality Management System; 1.3.2 What Has ISO 9001 Brought?; 1.3.3 How EFQM Brought NMMI Further AlongßtheßRoad toßExcellence; References; Internet Sources; 2: Good Clinical Practices inß(Nuclear) Research; 2.1 Origin ofßtheßGCP Regulations; 2.1.1 Nuremberg Code; 2.1.2 Declaration ofßHelsinki ; 2.1.3 The Development ofßtheßGood Clinical Practice Guideline.
2.1.4 Conducting aßClinical Study inßCompliance withßGCP2.1.4.1 Phases; 2.2 The Independent Ethics Committee (IEC) or Institutional Review Board (IRB); 2.2.1 Necessary Documents; 2.2.2 Approval ofßaßStudy Proposal; 2.2.3 Content ofßanßIEC Approval Letter; 2.2.4 Progress Reporting; 2.2.5 Composition andßFunctioning ofßanßIndependent Ethics Committee; 2.3 The Investigator; 2.3.1 Qualifications ofßanßInvestigator; 2.3.2 Facilities Needed toßQualify forßaßGCP Study; 2.3.3 Emergency Care; 2.3.4 Communicating withßtheßIEC/IRB.
2.3.5 Is Compliance toßtheßStudy Protocol Required According toßICH GCP?2.3.6 Investigational Medicinal Product; 2.3.6.1 What Is Required forßInvestigational Medicinal Products (IMPs)?; 2.3.6.2 Should theßInvestigator Comply withßtheßRandomization Procedure andßUnder Which Circumstances Should theßInvestigator Break theßStudy Code inßaßDouble-Blind Study?; 2.3.7 Informed Consent Procedure; 2.3.8 Nontherapeutic Trials; 2.3.8.1 Informed Consent forßLegally Restraint Subjects; 2.3.9 Records andßReporting Requirements; 2.3.9.1 Progress Reporting; 2.3.10 Safety Reporting.
2.3.10.1 Annual Safety Reporting2.3.10.2 Premature Temporarily or Final Stop ofßtheßStudy; 2.4 The Sponsor; 2.4.1 Delegation toßaßContract Research Organization (CRO)?; 2.4.2 Arrangements forßTrial Management, Data Handling, andßRecord Keeping; 2.4.3 Investigational Medicinal Products (IMPs) andßtheßTasks ofßtheßSponsor; 2.4.4 What Should theßSponsor Do toßEnsure Direct Access inßtheßMedical Files ofßtheßSubjects?; 2.4.5 Which Safety Information ofßtheßIMP Should BeßMade Available byßtheßSponsor?; 2.4.6 Reporting ofßAdverse Drug Reactions; 2.4.6.1 Adverse Event (AE).