A Practical Guide to Quality Management in Clinical Trial Research: 1st Edition (Hardback) book cover

A Practical Guide to Quality Management in Clinical Trial Research

1st Edition

By Graham Ogg

CRC Press

232 pages | 5 B/W Illus.

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Hardback: 9780849397226
pub: 2005-11-01
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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.


"…provides the reader with a pragmatic approach to the principles governing accepted methodologies within the working environment and provides some useful examples of these interpretational differences across industry."


"…provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations."

--Anticancer Research

Table of Contents


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


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 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


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


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


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


Other Quality Systems: A Brief History

Quality Control vs. Quality Assurance


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?


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?


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


Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology