Nonclinical study contracting and monitoring : a practical guide /

Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample rep...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Salminen, William F., Fowler, Joe M., Greenhaw, James
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Amsterdam ; Boston : Elsevier Science, 2013.
Temas:
Medical laboratories.
Clinical Laboratory Techniques > standards
Contract Services > organization & administration
Evaluation Studies as Topic
Laboratories > organization & administration
Laboratories > standards
Medical Laboratory Science > standards
Laboratories
M�edecine > Laboratoires.
MEDICAL > Instruments & Supplies.
Medical laboratories
Internet Resources.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover; Nonclinical Study Contracting and Monitoring: A Practical Guide; Copyright; Contents; List of Contributors; Chapter 1
  • Introduction; Key Points; GLPS AND NONCLINICAL STUDIES; CROS AND NONCLINICAL STUDIES; STUDY DIRECTORS; EXAMPLES OF STUDY ISSUES; CONCLUSION; Chapter 2
  • Good Laboratory Practices; Key Points; US FDA (21 CFR PART 58) AND OECD GLPS; SUBPART A
  • GENERAL PROVISIONS; SUBPART B
  • ORGANIZATION AND PERSONNEL; SUBPART C
  • FACILITIES; SUBPART D
  • EQUIPMENT; SUBPART E
  • TESTING FACILITIES OPERATION; SUBPART F
  • TEST AND CONTROL ARTICLES.
  • SUBPART G
  • PROTOCOL FOR AND CONDUCT OF A NONCLINICAL LABORATORY STUDYSUBPART J
  • RECORDS AND REPORTS; GLP FACILITY INSPECTIONS; GLP AUDITING CHECKLIST; Chapter 3
  • Study Design; Key Points; GENERAL STUDY DESIGN ISSUES; STUDY DESIGN CHECKLIST; Chapter 4
  • Animal Welfare; Key Points; THE "GUIDE"; REGULATIONS ESTABLISHED BY THE USDA UNDER THE AWA; POTENTIAL CONFLICTS BETWEEN THE ANIMAL WELFARE REQUIREMENTS, GLPS, AND OTHER STUDY REQUIREMENTS; ANIMAL WELFARE CHECKLIST; Chapter 5
  • Laboratory Selection; Key Points; CONTACTING AND PRELIMINARY SCREENING OF A NEW LABORATORY.
  • VISITING AND AUDITING A NEW LABORATORYLABORATORY SELECTION CHECKLIST; Chapter 6
  • Project Proposal; Key Points; DETAILED STUDY OUTLINE; PRICE NEGOTIATION; DETAILED STUDY OUTLINE TEMPLATE; Chapter 7
  • Contracts and Business Ethics; CONFIDENTIALITY; Key Points; CONTRACTS; MAINTAINING CONFIDENTIALITY DURING THE STUDY; BUSINESS ETHICS; EXAMPLE OF A CONFIDENTIAL DISCLOSURE AGREEMENT; Chapter 8
  • Study Protocol Preparation, Review, and Approval; Key Points; WRITING THE FIRST DRAFT; REVIEWING THE DRAFT PROTOCOL; FINALIZING THE PROTOCOL; CHANGING THE FINALIZED PROTOCOL; PROTOCOL CHECKLIST.
  • Chapter 9
  • Test ArticleTEST AND CONTROL ARTICLE SYNTHESIS AND SOURCING; Key Points; TEST AND CONTROL ARTICLE CHARACTERIZATION; MIXTURES OF TEST ARTICLES; TEST ARTICLE AND MIXTURE RECEIPT, STORAGE, AND TRACKING; ADDITIONAL CONSIDERATIONS; Chapter 10
  • Study Start Through End of In-Life; TEST ARTICLE AND FORMULATIONS; Key Points; ACQUIRING ANIMALS; PRE-STUDY MEETING; FIRST DAY OF DOSING; PROTOCOL DEVIATIONS AND AMENDMENTS; STUDY UPDATES, DATA AUDITING, AND GLP COMPLIANCE; NECROPSY; Chapter 11
  • Study Communication and Data Management; Key Points; HANDLING ISSUES THAT MAY ARISE; DATA MANAGEMENT.
  • STUDY REPORTS AND ARCHIVINGCOMMUNICATING STUDY RESULTS; STUDY AUDIT TEMPLATE; Chapter 12
  • A Study Director's Perspective on Study Monitor-Study Director Interactions; ESTABLISHING THE WORKING RELATIONSHIP; Key Points; SETTING YOUR EXPECTATIONS; THE STUDY DIRECTOR'S EXPECTATIONS OF YOU; PRE-PROTOCOL COMMUNICATIONS; PROTOCOL DEVELOPMENT; THE PRE-STUDY MEETING; VISITING THE LABORATORY; STUDY UPDATES; STUDY ISSUES AND THE UNEXPECTED; REPORTING; CONCLUSIONS; Chapter 13
  • Draft Report; Key Points; SETTING EXPECTATIONS; RECEIVING THE DRAFT REPORT; SENDING COMMENTS TO THE LABORATORY; SUMMARY.
  • Chapter 14
  • Final Report, Study Close-Out, and Conclusions.

Ejemplares similares