Quality in nuclear medicine / Andor W.J.M. Glaudemans, Jitze Medema, Annie K. van Zanten, Rudi A.J.O. Dierckx, editors ; C.T.B. (Kees) Ahaus, guest editor.
Contributor(s): Dierckx, Rudi A. J. O., editor literario
| Glaudemans, Andor W. J. M., editor literario | Medema, Jitze,, editor literario | Zanten, Annie K. van,, editor literario
Material type: 
E-bookPublisher: Switzerland : Springer International Publishing, 2016Description: 1 recurso en línea.ISBN: 3319335316; 9783319335315.Subject: Medicina nuclearOnline resources: Acceso a este recurso digital (usuarios Universidad Europea de Madrid)
| Item type | Current library | Collection | Call number | Status | Date due | Barcode | Item holds | |
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LIBRO-E NO PRÉSTAMO
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Madrid Digital Acceso Electrónico (UEM) | Ciencias de la Salud | R895 .Q355 2016 EB (Browse shelf(Opens below)) | Acceso electrónico | eBook.20022495 |
Foreword; Preface; Contents; Part I: Laws, Standards and Guidelines; 1: The Road to€Excellence: A€Case Study of€the€Application of€GMP, ISO 9001 and€the€EFQM Excellence Model in€a€Nuclear Medicine Department; 1.1 Introduction to€Quality and€Excellence; 1.2 Quality Definitions and€Standards in€Quality Management; 1.2.1 Quality Definitions; 1.2.1.1 Quality; 1.2.1.2 Quality in€Health Care; 1.2.1.3 Quality Management; 1.2.2 Standards and€Models; 1.2.2.1 Good Manufacturing Practice (GMP) (De Vos et€al. 2005); 1.2.2.2 Good Clinical Practice (GCP).
1.2.2.3 ISO 9000 Family of€Quality Management Systems Standards and€ISO 90011.2.2.4 EFQM Excellence Model; 1.3 Quality Management at NMMI in€UMCG; 1.3.1 The Evolving Role of€the€Quality Management System; 1.3.2 What Has ISO 9001 Brought?; 1.3.3 How EFQM Brought NMMI Further Along€the€Road to€Excellence; References; Internet Sources; 2: Good Clinical Practices in€(Nuclear) Research; 2.1 Origin of€the€GCP Regulations; 2.1.1 Nuremberg Code; 2.1.2 Declaration of€Helsinki ; 2.1.3 The Development of€the€Good Clinical Practice Guideline.
2.1.4 Conducting a€Clinical Study in€Compliance with€GCP2.1.4.1 Phases; 2.2 The Independent Ethics Committee (IEC) or Institutional Review Board (IRB); 2.2.1 Necessary Documents; 2.2.2 Approval of€a€Study Proposal; 2.2.3 Content of€an€IEC Approval Letter; 2.2.4 Progress Reporting; 2.2.5 Composition and€Functioning of€an€Independent Ethics Committee; 2.3 The Investigator; 2.3.1 Qualifications of€an€Investigator; 2.3.2 Facilities Needed to€Qualify for€a€GCP Study; 2.3.3 Emergency Care; 2.3.4 Communicating with€the€IEC/IRB.
2.3.10.1 Annual Safety Reporting2.3.10.2 Premature Temporarily or Final Stop of€the€Study; 2.4 The Sponsor; 2.4.1 Delegation to€a€Contract Research Organization (CRO)?; 2.4.2 Arrangements for€Trial Management, Data Handling, and€Record Keeping; 2.4.3 Investigational Medicinal Products (IMPs) and€the€Tasks of€the€Sponsor; 2.4.4 What Should the€Sponsor Do to€Ensure Direct Access in€the€Medical Files of€the€Subjects?; 2.4.5 Which Safety Information of€the€IMP Should Be€Made Available by€the€Sponsor?; 2.4.6 Reporting of€Adverse Drug Reactions; 2.4.6.1 Adverse Event (AE).
2.3.5 Is Compliance to€the€Study Protocol Required According to€ICH GCP?2.3.6 Investigational Medicinal Product; 2.3.6.1 What Is Required for€Investigational Medicinal Products (IMPs)?; 2.3.6.2 Should the€Investigator Comply with€the€Randomization Procedure and€Under Which Circumstances Should the€Investigator Break the€Study Code in€a€Double-Blind Study?; 2.3.7 Informed Consent Procedure; 2.3.8 Nontherapeutic Trials; 2.3.8.1 Informed Consent for€Legally Restraint Subjects; 2.3.9 Records and€Reporting Requirements; 2.3.9.1 Progress Reporting; 2.3.10 Safety Reporting.
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