Good Clinical Practice: A Question & Answer Reference Guide 2024-2025

✍ Scribed by Donna W. Dorozinsky (editor)

• Publisher: Barnett International
• Year: 2024
• Tongue: English
• Leaves: 480
• Category: Library

✦ Table of Contents

Cover Page
Table of Contents
Introduction
Section 1: GCP Regulations, Standards, and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Study Sponsors and Investigator Site Monitoring
Section 4: Informed Consent
Section 5: Source Data/Documentation
Section 6: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 7: Institutional Review Boards and Ethics Committees
Section 8: Drug/Study Safety and Safety Reporting
Section 9: Quality Assurance & Auditing
Section 10: Regulatory Inspections
Section 11: Clinical Data Management
Section 12: Computerized Systems, Electronic Records, and e-Data Integrity
Section 13: Patient Recruitment and Clinical Trial Diversity
Section 14: Conflicts of Interest/Financial Disclosure
Section 15: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 16: Investigational Medicinal Product Management
Section 17: Fraud, Negligence, and Regulatory Non-Compliance
Section 18: The Trial Master File
Section 19: Risk Based Quality Management/Quality by Design
Section 20: Impact of World Events on Clinical Trial Management
Section 21: Decentralized Clinical Trials
Section 22: European Privacy and Data Protection/GDPR
Appendix: GCP Compliance Statistics and Trends
Index