Practical Guide to Quality Management in Clinical Trial Research gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel.

Features:

• Provides examples of accessible methods for setting up a quality system that meets regulatory requirements
• Includes useful information for standards such as GLPs, GCPs, and GMPs
• Covers both 21 CFR Part 11 and the new EU Clinical Trials Directive 2001/20/EC
• Examines key areas that QA should consider during the inspection of electronic systems such as the use of biometric authentication
• Identifies important activities that should be monitored to ensure regulatory compliance
• Presents detailed explanations of how to prepare, update, and maintain SOPs
• Contains advice on the training and development of personnel

Contents

In the Beginning There Was GLP

• Staff Perception of QA
• Qualities of a Quality Professional
• Training the Quality Professional
• Regulatory Requirements
• A Workable Quality System (Pseudo-GLP)
• Application of GLP Principles to Phase-I Clinical Trials
• Archive Considerations
• SOP and Design
• Laboratory Method Operating Procedures (MOPs)
• Preambles for SOPs
• Achieving the Purpose of SOP
• Building a Quality Assurance System
• Quality Control within Quality Assurance

Before GCP

• External Suppliers
• Staffing Issues: Meeting the Needs
• Quality System Evolution
• Clinical Equipment
• Ethical Permission to Carry Out a Study
• Clinical Protocol Audits
• Control of Test Substances
• Volunteer Issues
• After GCP
• Problems with Nomenclature and Pan-European Consensus
• Test Substances: Controls and Comparators
• Investigational Medicinal Products (IMP) and Good Manufacturing Practice (GMP)
• Other GMP Considerations
• Support Services: What Standard?
• Ethics Committees (IRB) and GCP
• SOPs in the Clinical Area
• Planned SOP Deviations
• Data Protection Act (1988, U.K.) and Freedom of Information Act (2000, U.K.)
• Information Security
• Standardized Reports: Regulatory Submissions
• Archived Data Disposal
• Organization's Policy on Fraud

Training in the Regulated Environment

• Training of Laboratory Staff
• Laboratory-Based Nonscientific Staff
• Training in Data Management
• Training of QA Staff
• Training for Archivists
• Training of Medical, Nursing, and Technical Staff
• Training for Medical Staff
• Different Training (Learning) Methods for Different Areas?
• Assessment of Training Effectiveness - How?
• QA Inspection Points

Computing in the Regulated Environment

• Before 21 CFR Part 11
• IT Systems in Organizations
• Validation of Computing Systems
• After 21 CFR Part 11
• 21 CFR 11 - Key Elements
• Electronic Records and Signatures
• Electronic Signatures
• Assistance with Validation and Risk Assessment
• Electronic SOPs (E-SOPs) vs. Paper SOPs
• E-Archives
• Server Backup Considerations
• A Suggested Tape Backup/Archive Routine (With 22 Tapes for an Annual System)
• E-Mail in the Regulated Environment
• E-Mail Security
• E-Transfer of Documents and Signatures
• Digital Signatures in Documents
• QA and User Authentication to Computer Systems
• Definitions of Biometrics
• IT Security Considerations
• Internal Security
• External Security

QA Activity

• When Do You Carry Out an Inspection?
• How Often Do You Inspect?
• What Records Should QA Keep?
• Checklist of Various Items in a Clinical Inspection
• Clinical Inspection Procedure
• Long-Term Projects: Data Review Procedures
• Archive Inspection
• Personal Research Projects (Non-GxP)
• CVs and Training Records
• Job Descriptions
• Carrying Out External Audits
• Approval Process Smooth QA Operations
• Quality Metrics
• QA Reporting
• Report Audit Procedures
• QA Record Keeping

Beyond Compliance

• Other Quality Systems: A Brief History
• Quality Control vs. Quality Assurance

Business Improvement

• Managing Quality
• Responsibilities: QA and Management
• Protocols, Contracts, and Quality
• Total Quality Management
• System Inspection: A Change in Viewpoint
• Medics and Management
• IT to the Rescue?
• e-Archives
• The IT Infrastructure Option: The Works
• Problems with Electronic Systems
• Asset Management: Staff
• The QP: An Asset or Liability?
• Business Continuity
• Possible Business Continuity Plan
• So You Think You Have a Good Quality System?
• How Does the Baldridge System Work

Summary

• Defining Your QA Person
• Defining Your Quality System
• Academic Studies
• Sponsor Audit Preparation
• The Site Master File/Dossier
• Auditor/Inspector Interview
• U.K. GCP Regulatory Inspections
• Developing Your Systems

Index

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