Оглавление
P. Michael Dubinsky. The Fundamentals of Clinical Research
Table of Contents
List of Tables
List of Illustrations
Guide
Pages
The Fundamentals of Clinical Research. A Universal Guide for Implementing Good Clinical Practice
Preface. Goal
Scope of this Book
How to Use this Book
Opinion of the Authors
About the Authors
About the Authors
1 History
GCP Key Point
1.1 Introduction
1.2 Objectives
1.3 Chronology
1.4 The Emergence of the ICH and Its Guidelines
1.5 Summary
Knowledge Check Questions
References
2 Regulatory Environment
GCP Key Point
2.1 Introduction
2.2 Objective
2.3 Regulatory Matrix
2.4 Laws, Regulations, and Policies
2.5 Guidelines and Guidance Materials
2.6 Regulatory/Competent Authority Organizations
2.7 Academic Medical Centers (AMCs)
2.8 Professional Organizations
2.9 Summary
Knowledge Check Questions
References
3 GCP in Context
GCP Key Point
3.1 Introduction
3.2 Objectives
3.2.1 Discovery
3.2.2 1.4 Pre‐Clinical Studies
3.2.3 Clinical Studies
3.2.4 Manufacturing the Investigational Drug Product
3.2.5 Common Properties of GXPs
3.3 Summary
Knowledge Check Questions
Reference
4 The Intersection of GCP and Regulation
GCP Key Point
4.1 Introduction
4.2 Objectives
4.3 The Principles of ICH E6(R2)
4.4 The Definition of GCP Embodies the Full Spectrum of Trial Activity – The Definition of GCP Reads. 4.4.1 Good Clinical Practice (GCP)
4.5 Glossary
4.6 Combining Key Elements
4.7 Being Linked to an Organization That Is Respected and Authoritative
4.8 Standard Operating Procedures
4.9 Efficiency of Developing and Updating Materials
4.10 Value Added Practices and Principles are Adopted
4.11 Summary
Knowledge Check Questions
Reference
5 Regulatory Affairs
GCP Key Point
5.1 Introduction
5.2 Objectives of the Chapter
5.3 Regulatory Affairs
5.4 Interacting with Regulatory/Competent Authorities
5.5 Communicating with Regulatory/Competent Authorities and Others
5.6 Meetings – When and How They fit‐GCP
5.7 Applications
5.8 Summary
Knowledge Check Questions
References
6 GCP Definition and Principles
GCP Key Point
6.1 Introduction
6.2 Objectives
6.3 The Definition of Good Clinical Practice
6.4 Good Clinical Practice Principles
6.5 Summary
Knowledge Check Questions
Reference
7 Players Roles and Responsibilities Overview
GCP Key Point
7.1 Introduction
7.2 Objectives
7.2.1 Main Players Involved in the Conduct of a Clinical Trial
7.2.1.1 The Sponsor
7.2.1.2 The Investigator
7.2.1.3 The Subject/Trial Subject
7.2.1.4 The IRB/IEC
7.2.1.5 The Regulatory Authority
7.2.2 How the Main Players Interact
7.3 Summary
Knowledge Check Questions
Reference
8 IRB/IEC Roles and Responsibilities
GCP Key Point
8.1 Introduction
8.2 Objectives
8.3 Responsibilities of the IRB/IEC
8.3.1 Documents
8.4 Composition, Functions, and Operations
8.5 Procedures
8.6 Records
8.7 Noncompliance by IRB/IECs – Areas of Risk
8.8 Summary
Knowledge Check Questions
References
9 Investigator and Sponsor Roles and Responsibilities
GCP Key Point
9.1 Introduction
9.2 Objectives
9.2.1 Definitions
9.2.2 Sponsor and Investigator Responsibilities in the Context of the Clinical Trial Process
9.2.2.1 Before the Clinical Phase of the Trial Commences. 9.2.2.1.1 The Sponsor
9.2.2.1.2 The Investigator
9.2.2.1.3 The Sponsor
9.2.2.2 During the Clinical Conduct of the Trial. 9.2.2.2.1 The Investigator
9.2.2.2.2 The Sponsor
9.2.2.3 After Completion or Termination of the Trial. 9.2.2.3.1 The Investigator
9.2.2.3.2 The Sponsor
9.2.2.3.3 The Sponsor and Investigator
9.3 Summary
Knowledge Check Questions
References
10 The Research Volunteer
GCP Key Point
10.1 Introduction
10.2 Objectives
10.2.1 The Definition and Role of Trial Subject
10.2.2 Voluntary Responsibilities of a Trial Subject
10.2.2.1 Voluntary Responsibilities for Protection of Rights, Safety, and Well‐being
10.2.2.1.1 Prior to Volunteering for a Clinical Trial
10.2.2.1.2 Volunteering to Participate in the Trial
10.2.2.1.3 Participating in the Trial
10.2.2.2 Voluntary Responsibilities for Data Integrity
10.2.2.3 Voluntary Responsibilities for Trial Compliance
10.2.3 Quality by Design Considerations to Facilitate Subject Compliance with Trial Requirements
10.3 Summary
Knowledge Check Questions
Reference
11 Regulatory Authority – Roles and Responsibilities
GCP Key Point
11.1 Introduction
11.2 Objectives
11.3 Definition and Overview
11.4 Trial Approval – Submission of Applications
11.5 Communication, Reporting, and Oversight
11.6 Inspections and Oversight
11.7 Summary
Knowledge Check Questions
12 Individual Clinical Trial Overview
GCP Key Point
12.1 Introduction
12.2 Objectives
12.2.1 Trial Management
12.2.1.1 Defining Trial Initiation and Subject Enrollment
12.2.1.2 Trial Activities
12.2.1.2.1 Pre‐Study
12.2.1.2.2 On‐Study
12.2.1.2.3 End‐Study
12.2.2 Risk and Quality Management
12.2.3 Resourcing and Outsourcing
12.2.4 Investigational Product
12.2.4.1 Investigator’s Brochure
12.2.4.2 Clinical Supplies
12.2.5 Clinical Trial Protocol and Amendments
12.2.6 Human Subject Protection
12.2.7 IRB/EC and Regulatory Authority Communication
12.2.8 Data Collection and Data Management
12.2.9 Safety, Pharmacokinetics, and Pharmacodynamics Laboratory Testing
12.2.10 Safety Monitoring and Reporting
12.2.11 Trial Monitoring
12.2.11.1 Investigator/Institution Selection
12.2.11.2 Investigator/Institution Initiation
12.2.11.3 Interim Monitoring
12.2.11.4 Investigator/Institution Close‐out
12.2.12 Statistics and Data Analysis
12.2.13 Clinical Study Report
12.2.14 Essential Documents
12.2.15 Study Closeout
12.2.16 Consequences of Inadequate Trial Conduct
12.3 Summary
Knowledge Check Questions
Reference
13 Risk Assessment and Quality Management
GCP Key Point
13.1 Introduction
13.2 Objectives
13.3 Risk Assessment
13.3.1 Risk Identification and Evaluation
13.3.2 Risk Documentation
13.3.3 Risk Management
13.4 Summary
Knowledge Check Questions
Reference
14 Trial Management; Start‐up, On‐Study, and Close‐Out
GCP Key Point
14.1 Introduction
14.2 Objectives
14.2.1 Definition and Objectives of Trial Management
14.2.2 The Infrastructure for Trial Management
14.2.2.1 Overview of Functional Areas Involved in a Trial
14.2.2.2 Functions of the Sponsor
14.2.2.3 Functions of the Investigator
14.2.2.4 Qualifications and Role of the Study Lead
14.2.2.4.1 Tools for Trial Management
14.2.2.5 Overview of Trial Management Activities
14.2.2.5.1 Trial Initiation Activities
14.2.2.5.2 The Trial Initiation Process
14.2.2.5.3 On‐study Activities
14.2.2.5.4 The On‐study Process
14.2.2.5.5 End‐study and Study Closeout Activities
14.2.2.6 The Study Close‐Out Process. 14.2.2.6.1 Purpose of Study Closeout
14.2.2.6.2 Timing of Study Closeout
14.2.2.6.3 Study Closeout Checklist
14.2.2.6.4 Archiving Essential Documents
14.2.3 Typical Issues in Trial Management
14.3 Summary
Knowledge Check Questions
Reference
15 Trial Resourcing and Outsourcing
GCP Key Point
15.1 Introduction
15.2 Objectives
15.2.1 General Considerations for Resourcing and Outsourcing Trial Activities
15.2.2 Sponsor Responsibilities for Resourcing a Clinical Trial
15.2.3 Investigator Responsibilities for Resourcing a Clinical Trial
15.2.4 Processes for CRO Selection
15.2.5 Processes for CRO Contracting
15.2.6 Processes for CRO Management
15.2.7 Quality by Design Considerations for Resourcing and Outsourcing
15.3 Summary
Knowledge Check Questions
Reference
16 The Investigator's Brochure
GCP Key Point
16.1 Introduction
16.2 Objectives
16.2.1 Definition of an Investigator's Brochure
16.2.2 Purpose of an Investigator's Brochure
16.2.3 Context for an Investigator's Brochure in a Clinical Trial and in Clinical Development
16.2.4 Contents of an Investigator's Brochure
16.2.4.1 Title Page
16.2.4.2 Sections Within the Investigator's Brochure
16.2.5 Process for Developing an Investigational Brochure
16.2.5.1 Defining Roles and Timelines
16.2.5.2 Investigator Brochure Structure and Content
16.2.5.3 Drafting, Reviewing, and Approving the Investigator's Brochure
16.2.6 Updating an Investigator's Brochure
16.2.7 Quality by Design Considerations for the Contents of an Investigator's Brochure
16.3 Summary
Knowledge Check Questions
Reference
17 The Investigational Product (Clinical Supplies)
GCP Key Point
17.1 Introduction
17.2 Objectives
17.3 Manufacturing and Labeling Requirements
17.4 IP Accountability and Management
17.5 Factors to Consider in the Overall Trial Risk‐Assessment
17.6 Summary
Knowledge Check Questions
References
18 The Clinical Trial Protocol and Amendments
GCP Key Point
18.1 Introduction
18.2 Objectives
18.2.1 Definition of a Protocol
18.2.2 Context for a Protocol in Clinical Development
18.2.3 Purpose of a Protocol in a Clinical Trial
18.2.4 Contents of a Protocol
18.2.4.1 General Information
18.2.4.2 Background Information
18.2.4.3 Trial Objectives and Purpose
18.2.4.4 Trial Design
18.2.4.5 Selection and Withdrawal of Subjects
18.2.4.6 Treatment of Subjects
18.2.4.7 Assessment of Safety and Efficacy
18.2.4.8 Medical Care of Trial Subjects
18.2.4.9 Statistics
18.2.4.10 Direct Access to Source Data/Documents
18.2.4.11 Quality Control and Quality Assurance
18.2.4.12 Ethics
18.2.4.13 Data Handling and Recordkeeping
18.2.4.14 Financing and Insurance
18.2.4.15 Publication Policy
18.2.4.16 Supplements
18.2.5 Process for Developing a Protocol
18.2.5.1 Defining Roles and Timelines
18.2.6 Protocol Structure and Content
18.2.6.1 Creating the Protocol Synopsis or Summary
18.2.6.2 Drafting, Reviewing, and Approving the Protocol
18.2.7 Changes to a Protocol
18.2.8 Implementing the Protocol or Protocol Amendment
18.2.9 Quality‐by‐Design Considerations for the Contents of a Protocol
18.2.9.1 Trial Design. 18.2.9.1.1 Trial Objectives, Endpoints, and Procedures
18.2.9.2 Sample Sizes
18.2.9.3 Randomization and Blinding
18.2.9.4 Interim Analyses
18.2.9.5 Investigational Products
18.2.9.6 Eligibility Criteria
18.2.9.7 Informed Consent
18.2.9.8 Safety Monitoring
18.2.10 Study Assessments
18.2.11 Subject’s Rights and Medical care
18.2.12 Protocol Feasibility and Potential for Protocol Deviations
18.3 Summary
Knowledge Check Questions
References
Appendix
Appendix A: Schedule of Activities
19 Informed Consent and Other Human Subject Protection
GCP Key Point
19.1 Introduction
19.2 Objectives
19.2.1 Key GCP Principles of Human Subjects Protection
19.2.2 Measures to Protect Human Subjects
19.2.3 General Responsibilities for Protection of Human Subjects
19.2.4 Ethics Review of Study Information
19.2.5 Informed Consent
19.2.5.1 The Process of Consenting
19.2.5.2 Situations for Informed Consent
19.2.5.2.1 No Legally Acceptable Representative is Required
19.2.5.2.2 The Subject is Represented by a Legally Accepted Representative
19.2.5.2.3 The Subject or their Legally Accepted Representative is Unable to Provide Consent Prior to Trial Participation
19.2.5.2.4 The Subject or Their Legally Accepted Representative Is Unable to Read
19.2.5.2.5 Vulnerable Populations
19.2.5.3 Minimum Elements of Consent
19.2.5.4 Developing Consent Information and Documents. 19.2.5.4.1 General
19.2.5.4.2 “E”
19.2.5.4.3 “L”
19.2.5.4.4 “F”
19.2.5.5 Documentation of Consent
19.2.6 Confidentiality of Subject Identity
19.2.6.1 Protection of Biological Specimens
19.2.7 Compensation to Subjects
19.2.7.1 Trial‐Related Injury
19.2.7.2 Time, Effort, and Expenses
19.2.8 Medical Care for Subjects
19.2.9 Subject Withdrawal from the Study
19.2.10 Summary of Study Records Related to Human Subject Protection
19.3 Summary
Knowledge Check Questions
Reference
20 Data Collection and Data Management
GCP Key Point
20.1 Introduction
20.2 Objectives
20.3 GCP Responsibilities for Data Quality
20.3.1 Investigator Responsibilities for Data Quality
20.3.2 Sponsor Responsibilities for Data Quality
20.4 Data Flow in a Clinical Trial
20.5 Source Data and Source Documents. 20.5.1 Definitions
20.5.2 Purpose
20.5.3 Creating Source Data and Documents
20.6 Development and Implementation of the Case Report Form (CRF) 20.6.1 Definition
20.6.2 CRF Design
20.6.3 CRF Content
20.6.4 CRF Development Process and Testing
20.6.4.1 Resources for CRF Development
20.6.4.2 Development Process
20.6.4.3 Amending the CRF
20.7 Database Development
20.8 Data Management Processes
20.8.1 Data Entry
20.8.2 Data Monitoring and Cleaning
20.8.3 Data Merging and Reconciliation
20.9 Database Lock
20.10 The Data Management Plan
20.11 Quality‐by‐Design Considerations Regarding Clinical Trial Data Collection and Management
20.12 Summary
Knowledge Check Questions
Reference
21 Safety Monitoring and Reporting
GCP Key Point
21.1 Introduction
21.2 Objectives
21.2.1 General Responsibilities for Safety Management
21.2.2 Key Concepts for Safety Management Before the Trial Commences
21.2.3 Key Concepts for Safety Management During the Trial
21.2.4 Key Concepts for Safety Management After Trial Completion
21.2.5 Safety Reporting Definitions
21.2.5.1 Adverse Event
21.2.5.2 Adverse Drug Reaction (ADR)
21.2.5.3 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
21.2.5.4 Unexpected Adverse Drug Reaction
21.2.5.5 Events Associated with a Placebo
21.2.5.6 Timeframes for Reporting Safety Events
21.2.6 Procedures for Safety Reporting
21.2.6.1 Investigator Requirements for Safety Reporting
21.2.6.2 Sponsor Requirements for Safety Reporting
21.2.6.3 IRB/IEC Requirements for Safety Reporting
21.2.6.4 Records of Safety Reporting
21.2.7 The Safety Management Plan
21.2.8 Quality by Design Considerations for the Monitoring and Reporting of Safety Events
21.3 Summary
Knowledge Check Questions
References
22 Monitoring Overview
GCP Key Point
22.1 Introduction
22.2 Objectives
22.2.1 Definition of Monitoring
22.2.2 Why: The Purpose of Monitoring
22.2.3 Who: Qualification and Role of a Monitor. 22.2.3.1 Monitor Selection
22.2.3.2 Monitor Training
22.2.3.3 Monitor Familiarity with the Study Information
22.2.3.4 Monitor’s Role
22.2.4 What: The Individual Site Monitoring Checklist
22.2.5 Scope: The Extent and Nature of Monitoring
22.2.6 Strategy: On‐site and Centralized Monitoring
22.2.6.1 On‐site Review
22.2.6.2 Centralized Monitoring Checklist
22.2.6.3 Off‐site Review
22.2.7 When: The Timing of Monitoring
22.2.8 The Monitoring Plan
22.2.9 Reporting Monitoring Activities
22.3 Summary
Knowledge Check Questions
Reference
23 Investigator/Institution Selection
GCP Key Point
23.1 Introduction
23.2 Objectives
23.2.1 Who are Involved in Investigator Selection
23.2.2 What: Criteria for Qualifications and Fit
23.2.2.1 The Investigator/Institution Selection Checklist
23.2.3 How: Process for Investigator(S)/Institution(s) Selection
23.2.4 The Site Selection Visit. 23.2.4.1 The Selection Checklist
23.2.4.2 Preparing for the Visit
23.2.4.3 The Visit
23.2.4.4 The Selection Report
23.2.4.5 Follow‐up
23.2.5 Consequences of Poor Investigator(s)/Institution(s) Selection
23.3 Summary
Knowledge Check Questions
Reference
24 Investigator/Institution Initiation
GCP Key Point
24.1 Introduction
24.2 Objectives
24.2.1 Who are Involved in Investigator/Institution Initiation
24.2.2 What: Items that are Reviewed for Investigator/Institution Initiation
24.2.2.1 The Investigator/Institution Initiation Checklist
24.2.3 How: Process for Investigator(S)/Institution(s) Initiation
24.2.3.1 Central Investigators’ Training and Meetings
24.2.3.2 Individual Investigator/Institution Initiation
24.2.4 The Investigator/Institution Initiation Visit. 24.2.4.1 The Initiation Checklist
24.2.4.2 Preparing for the Visit
24.2.4.3 The Visit
24.2.4.4 The Initiation Report
24.2.4.5 Follow‐up
24.2.5 Consequences of Inadequate Investigator(s)/Institution(s) Initiation
24.3 Summary
Knowledge Check Questions
Reference
25 Investigator/Institution Interim Monitoring
GCP Key Point
25.1 Introduction
25.2 Objectives
25.2.1 Who are Involved in Investigator/Institution Interim Monitoring
25.2.2 What: Items that are Reviewed for Investigator/Institution Interim Monitoring
25.2.2.1 The Investigator/Institution Interim Monitoring Checklist
25.2.3 How: Process for Interim Monitoring
25.2.3.1 Centralized Interim Monitoring
25.2.3.2 Individual Investigator/Institution Interim Monitoring
25.2.4 The Investigator/Institution Interim Monitoring Visit. 25.2.4.1 The Interim Monitoring Visit Checklist
25.2.4.2 Preparing for the Visit
25.2.4.3 The Visit
25.2.4.4 The Interim Monitoring Visit Report
25.2.4.5 Follow‐up
25.2.5 Consequences of Inadequate Investigator(s)/Institution(s) Interim Monitoring
25.3 Summary
Knowledge Check Questions
Reference
26 Investigator/Institution Close‐out
GCP Key Point
26.1 Introduction
26.2 Objectives
26.2.1 The Purpose of Investigator/Institution Closeout
26.2.2 When Does Investigator/Institution Closeout Occur?
26.2.3 What: Items that are Reviewed for Investigator/Institution Closeout
26.2.3.1 The Investigator/Institution Closeout Checklist
26.2.4 How: Investigator/Institution Closeout Visit
26.2.4.1 The Closeout Visit Checklist
26.2.4.2 Preparing for the Visit
26.2.4.3 The Visit
26.2.4.4 The Investigator/Institution Closeout Visit Report
26.2.5 Follow‐up After Investigator/Institution Closeout
26.2.6 Consequences of Inadequate Investigator/Institution Closeout
26.3 Summary
Knowledge Check Questions
Reference
27 Study Design and Data Analysis
GCP Key Point
27.1 Introduction
27.2 Objectives
27.3 Clinical Trial Phases and Study Designs in Drug Development
27.3.1 Phase 1 to 3 Studies
27.3.2 Phase 4 Studies
27.4 GCP Considerations for Study Design and Analysis
27.4.1 Safety Considerations
27.4.2 Scientific Considerations
27.4.3 Data Integrity Considerations
27.5 Statistical Analysis Plan
27.6 Preparation of Study Data for Analysis
27.7 Analyzing and Reporting Study Data
27.8 Summary
Knowledge Check Questions
Comment and discuss:
References
28 The Clinical Study Report
GCP Key Point
28.1 Introduction
28.2 Objectives
28.2.1 Definition of a Clinical Study/Trial Report
28.2.2 Purpose of a Clinical Study/Trial Report
28.3 Context for a Clinical Study/Trial Report in a Clinical Trial and in Clinical Development
28.3.1 Types of Clinical Study/Trial Reports
28.3.2 Contents of a Clinical Study/Trial Report
28.3.2.1 Administrative
28.3.2.2 Study Conduct
28.3.2.3 Study Results
28.3.3 Process for Developing a Clinical Study/Trial Report
28.3.3.1 Defining Roles and Timelines
28.3.3.2 Clinical Study/Trial Report Structure and Content
28.3.3.3 Drafting, Reviewing, and Approving the Clinical Study/Trial Report
28.3.3.3.1 Developing the Clinical Study/Trial Report Synopsis
28.3.4 Typical Deficiencies in a Clinical Study/Trial Report
28.3.5 Changes to a Clinical Study/Trial Reports
28.3.6 Quality‐by‐Design Considerations for the Contents of a Clinical Study/Trial Report
28.4 Summary
Knowledge Check Questions
References
29 Essential Documents
GCP Key Point
29.1 Introduction
29.2 Objectives
29.2.1 Definition and Purpose
29.2.2 List of Essential Documents
29.2.3 Attributes of Essential Documents
29.2.4 Good Documentation Practices
29.2.4.1 ALCOAC Principles
29.2.4.2 Changes to Records
29.2.4.3 Certified Copies of Records
29.2.5 Structure and Location of Files. 29.2.5.1 All Trial Files
29.2.6 Sponsor Files
29.2.6.1 CRO Files
29.2.6.2 Investigator Files
29.2.7 Written Procedures Pertaining to Essential Documents
29.2.7.1 The Essential Documents File Index
29.2.7.2 Inventory of Essential Documents
29.2.7.3 Essential Documents Filing Plan
29.2.7.4 Quality Review of Files
29.2.8 Retention of and Continued Access to Essential Documents
29.2.8.1 Requirements for Retention
29.2.8.2 Retention Period
29.2.8.3 Access to Essential Documents
29.3 Summary
Knowledge Check Questions
Reference
30 Quality Systems in Clinical Research
GCP Key Point
30.1 Introduction
30.1.1 Objectives
30.1.2 Advent of Quality Systems in Clinical Research
30.1.3 Quality Systems Building Blocks
30.1.3.1 Written Procedures
30.1.3.2 Change Control
30.1.3.3 Qualification of People, Supplies, Vendors
30.1.3.4 Training
30.1.3.5 Record Keeping Systems and Documentation
30.1.3.6 Corrective and Preventive Action (CAPA)
30.1.3.7 Management Involvement
30.1.3.8 Risk Assessment and Management
30.1.4 Quality Control vs. Quality Assurance
30.1.5 Quality Systems Approach
30.1.6 Summary
Knowledge Check Questions
References
31 Quality Responsibilities
GCP Key Point
31.1 Introduction
31.1.1 Objectives
31.1.2 Sponsor
31.1.3 Contract Research Organization (CRO)
31.1.4 Clinical Investigator (CI)
31.1.4.1 Follow the Investigational Plan
31.1.4.2 Avoid Protocol Deviations
31.1.4.3 Documentation
31.1.4.4 INV Product Accountability
31.1.4.5 Communication
31.1.4.6 Subject Protections
31.1.5 Institutional Review Board/Independent Ethics Committee (IRB/IEC)
31.1.6 Additional Quality Factors
31.1.6.1 Organizational Structure
31.1.6.2 Communication
31.1.6.3 Operational
31.1.6.3.1 Management Involvement
31.1.6.3.2 Change Management/Change Control
31.1.6.3.3 Training
31.1.6.3.4 Qualifications
31.1.6.3.5 Recordkeeping and Documentation
31.1.6.3.6 Corrective and Preventive Action (CAPA)
31.1.6.3.7 Written Procedures
31.1.6.3.8 QA
31.1.6.3.9 QC
31.1.6.3.10 Risk Assessment and Management
31.1.7 Summary
Knowledge Check Questions
Reference
32 Standard Operating Procedures
GCP Key Point
32.1 Introduction
32.1.1 Objectives
32.1.2 Expectations/Requirements for SOPs
32.1.3 SOPs as Part of a Document Control Program
32.1.3.1 Controlled Versus Uncontrolled Documents
32.1.4 The Value of SOPs
32.1.4.1 Avoids Differing Interpretation of Requirements
32.1.4.2 Personnel Turnover
32.1.4.3 Differing Processes
32.1.4.4 Answers are Available Even if Management Is Not
32.1.4.5 Organizational Transparency Is Improved
32.1.4.6 Knowledge Transfer Is Facilitated
32.1.5 Issues with SOPs and How to Avoid Them
32.1.6 Avoiding SOP Issues
32.1.7 System Development and Configuration
32.1.7.1 The Status of the Organization’s Regulated Activities
32.1.7.2 The Size of the Organization and the Functions that are Being Performed
32.1.7.3 Employee Experience and Qualifications
32.1.7.4 Compliance History
32.1.8 SOP Program Configuration
32.1.8.1 System Content
32.1.8.2 Change Control
32.1.9 Summary
Knowledge Check Questions
33 Quality Assurance Components
GCP Key Point
33.1 Introduction
33.2 Objectives
33.3 Audit Plans
33.4 Audit Implementation
33.5 Corrective and Preventive Action – CAPA
33.6 Summary
Knowledge Check Questions
34 Regulatory Authority Inspections
GCP Key Point
34.1 Introduction
34.2 Objectives
34.3 Scheduling and Conducting GCP Inspections
34.4 Inspection Readiness – Preparation, Hosting, and Follow‐up
34.5 Summary
Knowledge Check Questions
References for all Chapters
Index. a
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