A Practical Guide to Quality Management in Clinical Trial Research
In: A Practical Guide to Quality Management in Clinical Trial Research; (2005-11-01)
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Zugriff:
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 Problem 1 Definitions of Biometrics Problem 2 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? A 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 End Note Information Resources and Acronyms Index
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A Practical Guide to Quality Management in Clinical Trial Research
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Autor/in / Beteiligte Person: | Ogg, Graham |
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Quelle: | A Practical Guide to Quality Management in Clinical Trial Research; (2005-11-01) |
Veröffentlichung: | CRC Press, 2005 |
Medientyp: | unknown |
DOI: | 10.1201/9781420036367 |
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