| Description |
1 online resource (214 pages) : illustrations |
| Contents |
IN THE BEGINNING THERE WAS GLP <BR>Staff Perception of QA <BR>Qualities of a Quality Professional <BR>Training the Quality Professional <BR>Regulatory Requirements<BR>A Workable Quality System (Pseudo-GLP)<BR>Application of GLP Principles to Phase-I Clinical Trials <BR>Archive Considerations <BR>SOP and Design <BR>Laboratory Method Operating Procedures (MOPs) <BR>Preambles for SOPs <BR>Achieving the Purpose of SOP<BR>Building a Quality Assurance System<BR>Quality Control within Quality Assurance <BR><BR>BEFORE GCP<BR>External Suppliers<BR>Staffing Issues: Meeting the Needs<BR>Quality System Evolution <BR>Clinical Equipment<BR>Ethical Permission to Carry Out a Study <BR>Clinical Protocol Audits<BR>Control of Test Substances <BR>Volunteer Issues <BR>After GCP<BR>Problems with Nomenclature and Pan-European Consensus <BR>Test Substances: Controls and Comparators<BR>Investigational Medicinal Products (IMP) and Good Manufacturing Practice (GMP) <BR>Other GMP Considerations<BR>Support Services: What Standard? <BR>Ethics Committees (IRB) and GCP <BR>SOPs in the Clinical Area <BR>Planned SOP Deviations<BR>Data Protection Act (1988, U.K.) and Freedom of Information Act<BR>(2000, U.K.)<BR>Information Security<BR>Standardized Reports: Regulatory Submissions<BR>Archived Data Disposal<BR>Organization's Policy on Fraud<BR><BR>TRAINING IN THE REGULATED ENVIRONMENT<BR>Training of Laboratory Staff<BR>Laboratory-Based Nonscientific Staff <BR>Training in Data Management<BR>Training of QA Staff <BR>Training for Archivists <BR>Training of Medical, Nursing, and Technical Staff <BR>Training for Medical Staff<BR>Different Training (Learning) Methods for Different Areas? <BR>Assessment of Training Effectiveness -- How? <BR>QA Inspection Points <BR><BR>COMPUTING IN THE REGULATED ENVIRONMENT<BR>Before 21 CFR Part 11 <BR>IT Systems in Organizations<BR>Validation of Computing Systems <BR>After 21 CFR Part 11 <BR>21 CFR 11 -- Key Elements <BR>Electronic Records and Signatures<BR>Electronic Signatures <BR>Assistance with Validation and Risk Assessment<BR>Electronic SOPs (E-SOPs) vs. Paper SOPs<BR>E-Archives <BR>Server Backup Considerations<BR>A Suggested Tape Backup/Archive Routine (With 22 Tapes for an Annual System) <BR>E-Mail in the Regulated Environment <BR>E-Mail Security<BR>E-Transfer of Documents and Signatures <BR>Digital Signatures in Documents <BR>QA and User Authentication to Computer Systems <BR>Problem 1 <BR>Definitions of Biometrics <BR>Problem 2 <BR>IT Security Considerations<BR>Internal Security<BR>External Security <BR><BR>QA ACTIVITY <BR>When Do You Carry Out an Inspection?<BR>How Often Do You Inspect? <BR>What Records Should QA Keep? <BR>Checklist of Various Items in a Clinical Inspection <BR>Clinical Inspection Procedure<BR>Long-Term Projects: Data Review Procedures<BR>Archive Inspection<BR>Personal Research Projects (Non-GxP)<BR>CVs and Training Records <BR>Job Descriptions <BR>Carrying Out External Audits <BR>Approval Process Smooth QA Operations<BR>Quality Metrics<BR>QA Reporting <BR>Report Audit Procedures<BR>QA Record Keeping<BR><BR>BEYOND COMPLIANCE <BR>Other Quality Systems: A Brief History <BR>Quality Control vs. Quality Assurance<BR><BR>BUSINESS IMPROVEMENT <BR>Managing Quality<BR>Responsibilities: QA and Management<BR>Protocols, Contracts, and Quality <BR>Total Quality Management<BR>System Inspection: A Change in Viewpoint<BR>Medics and Management <BR>IT to the Rescue?<BR>e-Archives<BR>The IT Infrastructure Option: The Works<BR>Problems with Electronic Systems<BR>Asset Management: Staff <BR>The QP: An Asset or Liability?<BR>Business Continuity<BR>Possible Business Continuity Plan<BR>So You Think You Have a Good Quality System?<BR>How Does the Baldridge System Work? <BR><BR>A SUMMARY<BR>Defining Your QA Person<BR>Defining Your Quality System<BR>Academic Studies<BR>Sponsor Audit Preparation <BR>The Site Master File/Dossier <BR>Auditor/Inspector Interview<BR>U.K. GCP Regulatory Inspections<BR>Developing Your Systems <BR>End Note <BR><BR>Information Resources and Acronyms<BR>Index |
| Summary |
Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is use |
| Bibliography |
Includes bibliographical references (pages 193-206) and index |
| Notes |
English |
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Print version record |
| Subject |
Clinical trials -- Quality control
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Biomedical Research -- standards
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Clinical Trials -- standards
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Research Design -- standards
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Total Quality Management -- methods
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MEDICAL -- Laboratory Medicine.
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| Form |
Electronic book
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| ISBN |
9781420036367 |
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142003636X |
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0429129181 |
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9780429129186 |
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1280653906 |
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9781280653902 |
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9786610653904 |
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6610653909 |
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