A Practical Guide to Quality Management in Clinical Trial Research

by Ogg; Graham

• ISBN13: 9780849397226
• ISBN10: 0849397227
• eBook ISBN(s): 9781040061633
• Format: Hardcover
• Copyright: 2005-11-01
• Publisher: CRC Press
• More Book Details

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 useful on a daily basis.The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.

Table of Contents

Chapter 1 In the Beginning There was GLP	1	(20)
Staff Perception of QA	2	(1)
Qualities of a Quality Professional	3	(1)
Training the Quality Professional	4	(1)
Regulatory Requirements	5	(3)
A Workable Quality System (Pseudo-GLP)	8	(2)
Application of GLP Principles to Phase-I Clinical Trials	10	(1)
Archive Considerations	11	(1)
SOP Contents and Design	12	(1)
Laboratory Method Operating Procedures (MOPs)	13	(1)
Preambles for SOPs	13	(1)
Purpose	14	(1)
Scope	14	(1)
Responsibility	14	(1)
Achieving the Purpose of SOPs	14	(2)
The Details: The Procedure	14	(1)
History of Revision	15	(1)
Document Control Functions	15	(1)
SOP Progression	16	(1)
Building a Quality Assurance System	16	(3)
How Can You Set Up Such a System?	16	(6)
Inspection	18	(1)
Audits	18	(1)
External Audits	19	(1)
Quality Control within Quality Assurance	19	(2)
Chapter 2 Before GCP	21	(38)
External Suppliers	21	(1)
Staffing Issues: Meeting the Needs	22	(2)
Company Needs	22	(1)
SOPs and Training	23	(1)
Sponsor Needs	23	(1)
Clinical Staff Needs	24	(1)
Quality System Evolution	24	(1)
Clinical Equipment	25	(1)
Ethical Permission to Carry Out a Study	25	(1)
Clinical Protocol Audits	26	(3)
General Considerations	27	(1)
Study Objectives	27	(1)
Drug Treatment	27	(1)
Assessments	27	(1)
Adverse Events	28	(1)
Withdrawals	28	(1)
Analysis of Results	28	(1)
Monitoring of Trial	28	(1)
Consent Procedure	28	(1)
Ethics Review	28	(1)
Declaration of Helsinki	28	(1)
Reports	29	(1)
Control of Test Substances	29	(1)
Volunteer Issues	30	(1)
After GCP	31	(2)
Problems with Nomenclature and Pan-European Consensus	33	(1)
Test Substances: Controls and Comparators	34	(1)
Investigational Medicinal Products (IMP) and Good Manufacturing Practice (GMP)	34	(3)
Other GMP Considerations	37	(11)
Temperature for Shipping	37	(1)
Quarantine for IMPs	37	(1)
Expiration Date Problems	37	(1)
Labels	38	(2)
Customer Complaints about IMPs	40	(8)
Support Services: What Standard?	48	(3)
Ethics Committees (IRB) and GCP	51	(1)
SOPs in the Clinical Area	52	(1)
Planned SOP Deviations	52	(1)
Data Protection Act (1988, U.K.) and Freedom of Information Act (2000, U.K.)	52	(1)
Information Security	53	(1)
Standardized Reports: Regulatory Submissions	54	(1)
Archived Data Disposal	55	(1)
Organization's Policy on Fraud	56	(3)
Chapter 3 Training in the Regulated Environment	59	(16)
Training of Laboratory Staff	60	(1)
Scientific Staff	60	(1)
Laboratory-Based Non-scientific Staff	61	(1)
Training in Data Management	61	(1)
Training of QA Staff	62	(2)
Documentation	62	(1)
Training Areas Identified	63	(1)
Training Period	64	(1)
Supervision	64	(1)
Ongoing Training	64	(1)
Training for Archivists	64	(2)
Methods	64	(1)
Implementation	65	(1)
Training of Medical, Nursing, and Technical Staff	66	(1)
Training for Medical Staff	67	(1)
Different Training (Learning) Methods for Different Areas?	68	(1)
Assessment of Training Effectiveness — How?	69	(3)
QA Inspection Points	72	(3)
Chapter 4 Computing in the Regulated Environment	75	(28)
Before 21 CFR Part 11	75	(2)
IT Systems in Organizations	77	(3)
Validation of Computing Systems	80	(3)
Quality Planning	81	(1)
System Requirements	81	(1)
Design, Construction, and Coding	81	(1)
Testing the System	81	(1)
Installation, Operation, and Support	81	(1)
Maintenance and Software Changes	82	(1)
Retirement	82	(1)
Validation: QA Notes	82	(1)
After 21 CFR Part 11	83	(1)
21 CFR 11 — Key Elements	83	(1)
Electronic Records and Signatures	83	(1)
Electronic Signatures	84	(3)
Risk Assessment Considerations	85	(2)
Assistance with Validation and Risk Assessment	87	(1)
Electronic SOPs (E-SOPs) vs. Paper SOPs	88	(1)
E-Archives	89	(2)
Server Backup Considerations	91	(1)
A Suggested Tape Backup/Archive Routine (With 22 Tapes for an Annual System)	92	(1)
E-Mail in the Regulated Environment	93	(1)
E-Mail Security	94	(1)
E-Transfer of Documents and Signatures	95	(1)
Digital Signatures in Documents	96	(1)
QA and User Authentication to Computer Systems	97	(1)
Problem 1	98	(1)
Definitions of Biometrics	98	(2)
Identification or Verification	98	(1)
Biometric Testing (a Selection, Tables 4.1 and 4.1a)	98	(1)
Biometrics	99	(1)
Problem 2	100	(1)
IT Security Considerations	101	(1)
Internal Security	101	(1)
External Security	101	(2)
Chapter 5 QA Activity	103	(26)
When do You Carry Out an Inspection?	103	(1)
How Often do You Inspect?	104	(1)
What Records Should QA Keep?	105	(1)
Checklist of Various Items in a Clinical Inspection	105	(3)
Clinical Inspection Procedure	108	(8)
Long-Term Projects: Data Review Procedures	116	(1)
Archive Inspection	116	(1)
Personal Research Projects (Non-GxP)	117	(1)
CVs and Training Records	117	(1)
Job Descriptions	118	(1)
Carrying Out External Audits	119	(1)
Approval Process	120	(1)
Smooth QA Operations	120	(1)
Quality Metrics	121	(2)
QA Reporting	123	(2)
Report Audit Procedures	125	(2)
Assuming that the Audit is Satisfactory	126	(1)
Assuming that the Audit is Unsatisfactory	127	(1)
QA Record Keeping	127	(2)
Chapter 6 Beyond Compliance	129	(20)
Other Quality Systems: A Brief History	129	(7)
Quality Control vs. Quality Assurance	136	(13)
Definitions	137	(1)
Protocol and Study Plan Compliance Checks	137	(1)
Tables to Raw-Data Check	137	(1)
Summary Check	137	(1)
Consistency Checks	137	(1)
Typographic Errors	138	(1)
Organizational Units and Report QC	138	(1)
Example Rejection Criteria To Be Used by a Subsequent OU	138	(1)
Final QA Audit	139	(1)
Sampling for Quality	139	(3)
Sampling for QA	142	(1)
Summary Statistics in Tables	142	(3)
Sampling Pharmacokinetic Parameters	145	(1)
Process Identification and Inspection	146	(3)
Chapter 7 Business Improvement	149	(30)
Managing Quality	149	(1)
Responsibilities: QA and Management	150	(3)
Protocols, Contracts, and Quality	153	(1)
Total Quality Management	154	(1)
System Inspection: A Change in Viewpoint	155	(1)
Physicians and Management	155	(1)
IT to the Rescue?	156	(1)
e-Archives	157	(2)
The IT Infrastructure Option: The Works	159	(1)
Problems with Electronic Systems	159	(4)
Asset Management: Staff	163	(1)
The QP: An Asset or Liability?	164	(1)
Business Continuity	165	(1)
Possible Business Continuity Plan	166	(4)
Introduction	166	(1)
Facility Risks of Fire, Explosion, and Flood	166	(2)
Fire	166	(1)
Flood	166	(1)
Contingency Planning	166	(1)
Loss or Failure of Tape Backup System	166	(1)
Damaged and Wet Paper Records	166	(1)
Administration System (Financial)	167	(1)
Pharmacy Supplies	167	(1)
Quality Assurance	167	(1)
Clinical Offices	167	(1)
Data Processing	167	(1)
Service Disruption	168	(2)
Utilities	168	(1)
Denial of Access to Building or Organization	169	(1)
Human Risks	169	(1)
Loss of Data to Human Error	169	(1)
Loss of Data Due to Theft or Malicious Acts	169	(1)
Mission-Critical Equipment with Significantly Impacting Loss Value	170	(1)
Alternative Solutions in Place?	170	(1)
Cessation of Archive Partner's Trading	170	(1)
Determining Risks	170	(1)
So You Think You Have a Good Quality System?	170	(4)
Level 1: European Quality Award (EQA)	172	(1)
Level 2: Recognized for Excellence	173	(1)
Level 3: Committed to Excellence	173	(1)
How Does the Baldridge System Work?	174	(5)
Quality Costing	175	(4)
Chapter 8 A Summary	179	(14)
Defining Your QA Person	179	(1)
Essential Qualities	179	(1)
Useful Qualities	179	(1)
Bonus Qualities	180	(1)
Defining Your Quality System	180	(1)
Academic Studies	181	(2)
Sponsor Audit Preparation	183	(2)
The Site Master File/Dossier	185	(1)
Auditor/Inspector Interview	186	(2)
U.K. GCP Regulatory Inspections	188	(2)
Developing Your Systems	190	(2)
Business Improvement	190	(1)
Costs of Quality	191	(1)
End Note	192	(1)
Information Resources and Acronyms	193	(14)
Index	207