Research Catalog

Title

Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections / Vera Mihajlovic-Madzarevic.

Author

Mihajlovic-Madzarevic, Vera

Publication

Hoboken, N.J. : John Wiley, c2010.

Items in the Library & Off-site

Details

Description

xxi, 246 p. : ill.; 25 cm.

Summary

"The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards." "This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals."--BOOK JACKET.

Subjects

• Guideline Adherence > standards
• Drugs > Testing > Auditing
• Medical audit
• Clinical Trials as Topic > standards
• Management Audit
• Quality Control

Bibliography (note)

• Includes bibliographical references and index.

Contents

• Chapter 1. Good Clinical Practice and Therapeutic Product Development -- 1.1. Good Clinical Practice in Clinical Research -- 1.1.1. Definition -- 1.1.2. GCP Compliance -- 1.1.3. GCP Objectives -- 1.1.4. Principles of ICH GCP -- Clinical Trial Conduct -- Risk Assessment -- Subject's Rights and Safety -- Background Information -- Clinical Trial Protocol -- Ethics Review and Approval -- Medical Care of Trial Subject -- Qualifications of Clinical Trial Personnel -- Informed Consent Process -- Data Management -- Patient Confidentiality -- Investigational Product Manufacturing, Handling, and Storage -- Quality Assurance -- 1.1.5. GCP Applicability -- 1.2. Role of the Sponsor of a Clinical Investigation -- 1.2.1. GCP: Responsibilities of a Sponsor of a Clinical Trial -- 1.2.2. Essential Documents for the Clinical Trial -- Retention of the Essential Documents for the Clinical Trial -- Archiving of the Essential Documents for the Clinical Trial After Discontinuation of Development -- Notification -- Transfer of Data Ownership -- Records Retention -- 1.2.3. Investigator Selection -- Investigator's Qualifications -- Resources at the Investigator's Site -- Protocol and Investigator's Brochure -- Agreement with the Investigator/Institution -- 1.2.4. Allocation of Responsibilities -- 1.2.5. Compensation to Subjects and Investigators -- Compensation to Subjects for Trial-Related Injuries -- Other types of Compensation to Trial Subjects -- 1.2.6. Financing -- 1.2.7. Notification/Submission to Regulatory Authorities -- 1.2.8. Confirmation of Review by IRB/IEC -- 1.2.9. Information on Investigational Products -- 1.2.10. Manufacturing, Packaging, Labelling, and Coding Investigational Products -- Characterization, Manufacturing, and Labeling of the Investigational Product -- Storage Conditions -- Packaging of the Investigational Product -- Coding and Decoding of the Investigational Product -- Investigational Product Changes and Bioequivalence Studies -- 1.2.11. Supplying and Handling Investigational Products -- Supply -- Investigational Product Records -- 1.2.12. Record Access -- Verification of Patient Consent to Record Access -- 1.2.13. Safety Information -- Safety Issues -- Communication of Safety Issues -- 1.2.14. Adverse Drug Reaction Reporting -- Serious Unexpected Adverse Drug Reactions -- SAE Reporting Compliance -- Safety Updates and Periodic Reports -- 1.2.15. Monitoring -- Purposes -- Selection and Qualifications of Monitors -- Monitoring Strategies -- Monitor's Responsibilities -- Monitoring Procedures -- Monitoring Report -- 1.2.16. Audit -- Purposes -- Selection and Qualifications of Auditors -- Auditing Procedures -- Site Selection Criteria for Inspection -- Reporting of Findings -- Audit Certificate -- 1.2.17. Noncompliance -- 1.2.18. Premature Termination or Suspension of a Trial -- 1.2.19. Clinical Trial/Study Reports -- 1.2.20. Multicenter Trials -- 1.3. Role of the Institutional Review Board/Independent Ethics Committee (IRB/IEC) -- 1.3.1. Responsibilities -- Document Gathering -- Review of Documentation -- 1.3.2. Considerations for Review -- 1.3.3. Additional Information to be Provided to Subjects -- Nontherapeutic Trials -- Emergency Situations -- Payment to Study Subjects -- Payment Information in the Consent Form -- Composition, Functions, and Operations -- IRB/IEC Standard Operating Procedures -- Records -- 1.4. Roles and Responsibilities of the Clinical Trial Investigator -- 1.4.1. Investigator's Qualifications and Agreements -- 1.4.2. Adequate Resources -- 1.4.3. Medical Care of Trial Subjects -- 1.4.4. Communication with IRB/IEC -- 1.4.5. Compliance with Protocol -- 1.4.6. Investigational Product(s) -- 1.4.7. Randomization Procedures and Unblinding -- 1.4.8. Informed Consent of Trial Subjects -- 1.4.9. Records and Reports -- 1.4.10. Progress Reports -- Safety Reporting -- 1.4.11. Premature Termination or Suspension of a Trial -- 1.5. Clinical Trial Protocol and Protocol Amendments -- 1.5.1. Contents of Trial Protocol -- 1.5.2. Investigator's Brochure -- Introduction -- General Considerations -- Contents of the Investigator's Brochure -- Chapter 2. Therapeutic Products Clinical Development in the United States -- 2.1. Drug Discovery -- 2.2. Preclinical Development -- 2.2.1. In Vitro Testing -- 2.2.2. In Vivo Testing (Animal Testing) -- 2.3. Clinical Development -- 2.4. FDA Considerations for Drug Development -- 2.4.1. Pre-IND Meeting -- 2.4.2. End of Phase II Meeting -- 2.4.3. Pre-NDA Meeting -- 2.5. Phase IV, Postmarketing Surveillance and GCP -- 2.6. Quality Assurance in Clinical Research -- 2.7. FDA Inspectional Background and Data -- 2.7.1. The FDA and GCP -- 2.7.2. FDA: Responsibilities of the Sponsor (Subpart D 21 CFR 312.50 to 21 CFR 312.58) -- 2.7.3. FDA: Responsibilities of the Investigator - (Subpart D 21 CFR 312.50 to 21 CFR 312.58) -- Investigator Recordkeeping and Record Retention -- Investigator Reports -- Assurance of IRB Review -- Inspection of Investigator's Records and Reports -- Handling of Controlled Substances -- Disqualification of a Clinical Investigator -- 2.7.4. FDA: Responsibilities of the Institutional Review Board (21 CFR Part 56) -- Circumstances in Which IRB Review is Required -- Exemptions from IRB Requirement -- Waiver of IRB Requirement -- IRB Membership -- IRB Functions and Operations -- IRB Review of Research -- Expedited Review Procedures for Certain Kinds of Research Involving No More than Minimal Risk and for Minor Changes in Approved Research -- Criteria for IRB Approval of Research -- Review by Institution -- Suspension or Termination of IRB Approval of Research -- Cooperative Research -- IRB Records -- Lesser Administrative Actions for Noncompliance -- Disqualification of an IRB or an Institution -- Public Disclosure of Information Regarding Revocation -- Reinstatement of an IRB or an Institution -- Actions Alternative or Additional to Disqualification -- 2.8. FDA Bioresearch Monitoring Program -- 2.8.1. Clinical Trials Inspectional Background -- 2.8.2. Program Objectives -- 2.8.3. Types of Inspections Performed by the FDA -- Routine Inspections -- Directed (for Cause) Inspections -- Classification of Inspections -- 2.8.4. Who is Inspected? -- 2.8.5. Implementation of the FDA's Application Integrity Policy -- 2.8.6. BIMO Inspections for Clinical Trials -- 2.8.7. The FDA and International GCP Inspections -- Criteria for International Sites Selection for Inspection -- Chapter 3. The Inspection Preparation -- 3.1. Conduct of an Internal GCP Inspection: Quality Assurance Inspection -- 3.2. Steps to Prepare for the Internal QA Inspection -- 3.2.1. Inspection of the Trial Master File (TMF) -- 3.2.2. Inspection of an Investigator Site -- 3.2.3. Inspection of the Contract Research Organization (CRO) -- 3.2.4. Inspection of Clinical Laboratories -- 3.3. The GCP Quality Assurance Unit -- 3.3.1. Scope of an Internal GCP Inspection -- 3.3.2. Outcome of an Internal Inspection -- 3.4. Steps to Prepare for the Regulatory Inspection -- 3.5. Clinical Investigator Inspections Preparation -- 3.6. What to do When an Investigator Site FDA Inspection in Announced -- 3.7. Sponsor's Inspection Preparation -- 3.8. What to do When Sponsors FDA Inspector Arrive Unannounced -- 3.9. The Institutional Review Board Inspections Preparation -- 3.9.1. Central IRBs -- 3.10. What to do When an IRB FDA Inspection is Announced -- 3.11. The Investigator Site Inspection -- 3.11.1. Objective of an FDA Investigator Site Inspection -- 3.11.2. Dynamics of a Clinical Investigator's Inspection (Scope) -- 3.12. Investigator's Responsibilities -- 3.13. Types of Clinical Investigator Site Inspections -- 3.14. Inspectional Procedures --
• 3.14.1. The Investigator Site Documentation and Organization -- 3.14.2. The Sponsor's Role in the Investigator Site Audit -- 3.14.3. The Clinical Investigator Site Inspection Step by Step: The Day of the Inspection -- 3.15. FDA Audit Procedures for Investigative Sites -- 1.15.1. Authority and Administration -- 3.15.2. Inspecting the Protocol -- 3.15.3. Inspecting Subjects' Records -- 3.15.4. Inspecting Other Study Records -- 3.15.5. Inspecting the Consent of Human Subjects -- 3.15.6. Inspecting the Institutional Review Board Documentation -- 3.15.7. Inspecting the Sponsor's Documentation and Communications at the Investigator Site -- 3.15.8. Inspecting the Investigational Product (Test Article Accountability) -- 3.15.9. Inspecting the Records Retention Process -- 3.15.10. Inspecting Electronic Records and Signatures -- 3.15.11. Inspecting Device Studies -- 3.16. FDA Inspections of International Clinical Trial Sites -- 3.17. The Audit Report and Form 483 -- 3.17.1. The Exit Interview -- 3.17.2. What is Form 483? -- 3.17.3. Responding to a Form 483 -- 3.17.4. The Follow-up -- 3.17.5. Warning Letter -- 3.17.6. Regulatory Actions Against Clinical Investigators -- Notice of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE) (312, 70) -- What is a Disqualification of an Investigator? -- What is the Consent Agreement? -- 3.17.7. The Clinical Hold -- Issue of the Clinical Hold -- Scope of the Clinical Hold -- Meaning of the Clinical Hold -- Extent of the Clinical Hold -- Lift of the Clinical Hold -- 3.17.8. Reinstatement of Disqualified Investigators -- 3.17.9. Regulatory Action Against Companies or Persons (Not Investigators): Debarment -- Chapter 4. Analysis of Warning Letters -- 4.1. Analysis of Warning Letters Issued to Clinical Investigators -- 4.1.1. Most Common Findings of Investigator Site Inspections -- Findings Relating to Patient Information and Consent Form and Process -- Findings Relating to Investigator's Supervision of the Clinical Trial -- Findings Relating to Protocol Adherence -- Findings Relating to Records in Clinical Trials -- Findings Relating to the Investigational Product in Clinical Trials -- Findings Relating to the Reporting of Adverse Events -- Findings Relating to the Institutional Review Board's Approvals and Reporting -- Findings Relating to the Investigator Acting in a Dual Role of Sponsor-Investigator -- 4.2. An Analysis of Warning Letters Issued to Clinical Trial Sponsors -- 4.2.1. Most Common Sponsors of Clinical Investigations Findings -- Findings Relating to the Sponsor's Responsibilities to Ensure Proper Monitoring of a Clinical Trial -- Findings Relating to the Sponsor's Responsibilities for the Investigational Product -- Findings Relating to the Sponsor's Records of a Clinical Investigation -- Findings Relating to the Sponsor Obtaining an IND to Conduct a Study -- Findings Relating to the Sponsor's Responsibilities to Secure Agreements within Parties -- 4.3. Analysis of Warning Letters Issued to Institutional Review Boards -- 4.3.1. Most Common Institutional Review Board Findings -- Findings Relating to IRB Operational Procedures -- Findings Relating to IRB Initial and Continuing Review Process -- Findings Relating to IRB Recordkeeping and Retention -- Findings Relating to IRB Composition and Membership -- Findings Relating to IRB Review Process -- Findings Relating to IRB Review Process of Special Populations in Clinical Trials -- Administrative Actions to IRBs -- Reinstatement of a Disqualified IRB -- Conclusions on the Findings -- Chapter 5. Fraud and Misconduct in Clinical Research -- 5.1. What Type of Data is Falsified? -- 5.2. How is Data Falsified? -- 5.3. Why is Data Falsified? -- 5.4. Who Falsified the Data? -- 5.5. What Can be Done to Detect Fraud? -- 5.6. How do we Prevent Fraud? -- APPENDIX A. SOME ANSWERS TO THE MOST PROBLEMATIC QUESTIONS IN COMPLIANCE -- How Can an Investigator Site Demonstrate That the Proper Consent Process was Followed? -- How does One Demonstrate that a Subject Understood the Consent Information? -- How does One Demonstrate that all the Clinical Trial Procedures were Followed? -- How does One Demonstrate Principal Investigator Personal Involvement in the Supervision of Clinical Trial Activities? -- Why Follow Standard Operating Procedures in Clinical Trials? -- APPENDIX B. GUIDANCE FOR INDUSTRY---E6 GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDANCE -- Introduction -- APPENDIX C. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS -- A. Introduction -- B. Basic Principles for all Medical Research -- C. Additional Principles for Medical Research Combined with Medical Care -- APPENDIX D. NUREMBERG CODE -- APPENDIX E. THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH -- Part A. Boundaries Between Practice and Research -- Part B. Basic Ethical Principles -- Part C. Applications.

ISBN

• 9780470248850 (cloth)
• 0470248858 (cloth)

LCCN

2009027971

OCLC

• ocn423572734
• 423572734
• SCSB-8877475

Owning Institutions

Columbia University Libraries