Buenas prácticas clínicas

P1: OTA/XYZ P2: ABC FM JWBS024-Madzarevic

April 1, 2010

14:43

Printer: Sheridan Books

CONTENTS
PREFACE
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xv

CHAPTER 1

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Good Clinical Practice in Clinical Research 2 1.1.1 Definition 2 1.1.2 GCP Compliance 2 1.1.3 GCP Objectives 2 1.1.4 Principles of ICH GCP 3 Clinical Trial Conduct 3 Risk Assessment 3 Subject’s Rights and Safety 3 Background Information3 Clinical Trial Protocol 3 Ethics Review and Approval 3 Medical Care of Trial Subject 4 Qualifications of Clinical Trial Personnel 4 Informed Consent Process 4 Data Management 4 Patient Confidentiality 4 Investigational Product Manufacturing, Handling, and Storage 4 Quality Assurance 4 1.1.5 GCP Applicability 5 Role of the Sponsor of a Clinical Investigation 6 1.2.1 GCP: Responsibilities of aSponsor of a Clinical Trial 6 1.2.2 Essential Documents for the Clinical Trial 9 Retention of the Essential Documents for the Clinical Trial 9 Archiving of the Essential Documents for the Clinical Trial After Discontinuation of Development 9 Notification 10 Transfer of Data Ownership 10 Records Retention 10 1.2.3 Investigator Selection 10 Investigator’s Qualifications 10 Resources at the Investigator’sSite 11 Protocol and Investigator’s Brochure 11 Agreement with the Investigator/Institution 11

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GOOD CLINICAL PRACTICE AND THERAPEUTIC PRODUCT DEVELOPMENT 1

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GLOSSARY

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INTRODUCTION xv Background History on Clinical Research Standards

P1: OTA/XYZ P2: ABC FM JWBS024-Madzarevic

April 1, 2010

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Printer: Sheridan Booksvi

CONTENTS

1.3

Allocation of Responsibilities 11 Compensation to Subjects and Investigators 12 Compensation to Subjects for Trial-Related Injuries 12 Other types of Compensation to Trial Subjects 12 1.2.6 Financing 12 1.2.7 Notification/Submission to Regulatory Authorities 13 1.2.8 Confirmation of Review by IRB/IEC 13 1.2.9 Information on Investigational Products 14 1.2.10Manufacturing, Packaging, Labelling, and Coding Investigational Products 14 Characterization, Manufacturing, and Labeling of the Investigational Product 14 Storage Conditions 14 Packaging of the Investigational Product 14 Coding and Decoding of the Investigational Product 14 Investigational Product Changes and Bioequivalence Studies 15 1.2.11 Supplying and Handling Investigational Products 15 Supply 15Investigational Product Records 15 1.2.12 Record Access 16 Verification of Patient Consent to Record Access 16 1.2.13 Safety Information 16 Safety Issues 16 Communication of Safety Issues 16 1.2.14 Adverse Drug Reaction Reporting 17 Serious Unexpected Adverse Drug Reactions 17 SAE Reporting Compliance 17 Safety Updates and Periodic Reports 17 1.2.15 Monitoring 17 Purposes 18 Selection and Qualifications ofMonitors 18 Monitoring Strategies 19 Monitor’s Responsibilities 19 Monitoring Procedures 21 Monitoring Report 21 1.2.16 Audit 21 Purposes 22 Selection and Qualifications of Auditors 22 Auditing Procedures 22 Site Selection Criteria for Inspection 22 Reporting of Findings 23 Audit Certificate 23 1.2.17 Noncompliance 23 1.2.18 Premature Termination or Suspension of a Trial 24 1.2.19 ClinicalTrial/Study Reports 24 1.2.20 Multicenter Trials 24 Role of the Institutional Review Board/Independent Ethics Committee (IRB/IEC) 25 1.3.1 Responsibilities 25 Document Gathering 25 Review of Documentation 26

1.2.4 1.2.5

P1: OTA/XYZ P2: ABC FM JWBS024-Madzarevic

April 1, 2010

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Printer: Sheridan Books

CONTENTS

vii

1.4

1.5

Considerations for Review 26 AdditionalInformation to be Provided To Subjects 26 Nontherapeutic Trials 26 Emergency Situations 26 Payment to Study Subjects 27 Payment Information in the Consent Form 27 Composition, Functions, and Operations 27 IRB/IEC Standard Operating Procedures 28 Records 29 Roles and Responsibilities of the Clinical Trial Investigator 29 1.4.1 Investigator’s Qualifications and Agreements 29 1.4.2 Adequate Resources 30 1.4.3...