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Clinical Research Compliance Manual: An Administrative Guide, Second Edition Clinical Research Compliance Manual: An Administrative Guide, Second Edition

Clinical Research Compliance Manual: An Administrative Guide, Second Edition

By Lawrence W. Vernaglia
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Overview

For anyone receiving or applying for clinical research funding, Clinical Research Compliance Manual: An Administrative Guide covers today's most crucial topics, including:

  • Human subject protections
  • Institutional Review Board regulations and requirements
  • Conflicts of interest
  • Scientific misconduct
  • Reimbursement issues
  • And much more!

Clinical Research Compliance Manual helps you establish best practices and carry out all administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent developments:

  • Covers the major clinical research issues - with chapters written by experts in the field
  • Provides legal explanations of the major regulatory issues in an easy-to-understand format
  • Includes summaries of federal regulatory agencies, analysis of major cases, flow-charts, checklists, and footnotes to compliance program development, auditing and monitoring

Clinical Research Compliance Manual has been updated to include:

  • A new chapter “GDPR Compliance Considerations”
  • Revised sections on federal grants administration
  • Updated research misconduct case studies
  • New information on the final revisions of the Common Rule
  • Analysis of artificial intelligence innovations
  • And much more!

Previous Edition: Clinical Research Compliance Manual: An Administrative Guide, ISBN 9780735569669

Publish Date 11/15/2018
Publish Frequency Updated annually
Product Line Wolters Kluwer Legal & Regulatory U.S.
ISBN 9781543806724
SKU 10070282-7777
Product Line Wolters Kluwer Legal & Regulatory U.S.
SKU 000000000010048339
Table of Contents
  • 1. OVERVIEW OF CLINICAL RESEARCH: ITS PRINCIPLES, PROCESSES, AND REGULATORY ENVIRONMENT
    • Background of the Clinical Research Process
    • Overview of Clinical Trials
    • The Role of the Food and Drug Administration in Clinical Trials
    • Obtaining FDA Approval for a Proposed New Drug
    • New Biologicals
    • Investigational and New Medical Devices
    • Informed Consent
    • Privacy and Confidentiality of Research Records and Information
    • Conflicts of Interest in Clinical Research
    • Reimbursement Issues Related to Clinical Trials
    • Anti-Kickback Fraud and Abuse Implications of Clinical Trials
    • Intellectual Property Issues in Clinical Research
    • Protecting Research Materials, Research Results, and Inventions: A University Perspective
    • International Regulation and Global Ethics in Clinical Research
  • 2. HUMAN SUBJECT PROTECTIONS IN CLINICAL RESEARCH
    • Historical Overview of Human Subject Protection in Clinical Research
    • FDA Human Subject Protection Regulations and Their Distinctions from HHS Regulations
    • Detailed Analysis of the Common Rule and OHRP Regulations for the Protection of Human Subjects
    • Additional Protections for Vulnerable Populations
    • Detailed Analysis of FDA Regulations for the Protection of Human Subjects
    • Compliance with Human Subject Protection Regulations
    • Guidance on Human Subject Protections
  • 3. INFORMED CONSENT IN FEDERALLY REGULATED RESEARCH
    • The Federal Requirements for Consent in Clinical Research
    • Federal Documentation Requirements for Consent in Clinical Research
    • Special Populations Recognized in Federal Clinical Research Regulations on Consent
    • Clinical Trials Consent Provisions and the FDA
    • State Laws on Consent in Clinical Research
    • The Effect of Regulatory Guidance on Consent in Clinical Research
    • Consent Litigation and Clinical Research
    • Emerging Issues in Clinical Research and Consent
    • Avoiding Consent Litigation in Clinical Research
  • 4. INSTITUTIONAL REVIEW BOARDS: THEIR ROLE AND RESPONSIBILITIES IN CLINICAL RESEARCH PROGRAMS
    • The History of the IRB System
    • Regulatory Structure of IRBs—OHRP
    • Registration of IRBs—OHRP
    • Criteria for Approval of Research—OHRP
    • Conduct of IRB Review—OHRP
    • Unanticipated Problems, Adverse Event Reporting, and Protocol Deviation/Violation—OHRP
    • FDA-Specific IRB Regulations
    • Criteria for IRB Approval of Research—FDA
    • Adverse Event Reporting—FDA
    • Registration of IRBs—FDA
    • Registration of Clinical Trials—FDA
    • Alternative (Independent) IRBs
    • Data Monitoring Committees
    • Protection of Vulnerable Human Subjects
    • Legal and Ethical Challenges Facing IRBs
    • Lessons Learned from the Johns Hopkins Experience
    • Exhibit 4-1 Categories of IRM Membership
    • Exhibit 4-2 Guidance for Institutional Review Boards and Clinical Investigators
    • Exhibit 4-3 IRB Reviewer Checklist: Children as Research Subjects
    • Exhibit 4-4 IRB Reviewer Checklist: Prisoners as Research Subjects
    • Exhibit 4-5 IRB Reviewer Checklist: Pregnant Women, Fetuses, and Newborns as Research Subjects
    • Exhibit 4-6 Data Elements for Interventional Trials
    • Exhibit 4-7 Quickguide to Facilitated Review
  • 5. OVERVIEW OF FEDERAL GRANTS ADMINISTRATION
    • What Are Federal Grants?
    • Sources of Law and Policy for Federal Grants
    • Overview of Key Provisions of the Uniform Guidance
  • 6. ADMINISTRATION OF NIH-SUPPORTED CLINICAL RESEARCH
    • Select Pre-Award Requirements
    • Select Post-Award Requirements
    • After-Award Requirements
    • Administrative Requirements for State, Local, and Tribal Governments
    • Monitoring, Enforcement, and Disputes
  • 7. KEY GRANTS MANAGEMENT AND ACCOUNTING ISSUES
    • Financial Management Overview
    • Internal Controls
    • Allowable Costs
    • Budget or Project Changes
    • New Issues in NIH Grants Management
  • 8. CONFLICT OF INTEREST RULES FOR FEDERALLY REGULATED CLINICAL RESEARCH
    • The Impact of Conflict of Interests: Gelsinger and Vioxx
    • Defining the Terms and Players
    • Institutional Interests: The Bayh-Dole Act
    • Conflict of Interest Regulations and Guidelines
    • Enforcement: The Federal False Claims Act
    • Conclusion: Practically Speaking
    • Exhibit 8-1. Checklist to Avoid Conflict of Interest in Clinical Studies
  • 9. MISCONDUCT IN CLINICAL RESEARCH
    • The Role of the Office of Research Integrity
    • The Definition of Research Misconduct
    • The 2005 Final Rule
    • Role of Journal Editors and Peer Reviewers in Detecting and Preventing Research Misconduct
    • Proving a Finding of Research Misconduct
    • Selected Research Misconduct Case Summaries
  • 10. A PRACTICAL GUIDE TO GOOD CLINICAL PRACTICE STANDARDS
    • Good Clinical Practices Are Born
    • The Core of the Consolidated GCP Guidance
    • GCP Risk Areas
    • The Basics of Good Clinical Practices
    • Selected Areas of Compliance Risk
    • Developing a Plan for Improving Compliance with GCPs
    • Exhibit 10-1 Clinical Trial Documentation Checklist
    • Exhibit 10-2 GCP Checklist: Assessing the Health of Your Institution
  • 11. KEY CONCEPTS IN REIMBURSEMENT FOR CLINICAL TRIALS
    • Medical Research Issues Relevant for Reimbursement Considerations
    • Reimbursement Rules
    • Enforcement Activities
  • 12. BEST PRACTICES AND LEGAL PRINCIPLES IN CLINICAL RESEARCH COMPLIANCE
    • Key Steps for Effective Compliance
    • Developing an Educational and Training Program
    • Assisting Research Personnel in Responding to and Coordinating Internal or Independent Auditors with Compliance Reviews and Monitoring Activities
    • Continual Assessment of Training Programs
    • Identification and Assessment of Risks
    • Independent Monitoring of Clinical Research Billing
    • Draft Compliance Program Guidance for Recipients of Public Health Research Awards
    • Legal Issues Associated with Clinical Research Billing
    • Exhibit 12-1 Clinical Research Compliance Education Matrix
    • Exhibit 12-2 Clinical Research Billing Compliance Checklist
    • Exhibit 12-3 Clinical Research Billing Monitoring Protocol Instructions
    • Exhibit 12-4 Action Item Grid for Supplemental Compliance Program Guidance for Hospitals
  • 13. INTELLECTUAL PROPERTY ISSUES AND DATA EXCLUSIVITY IN CLINICAL RESEARCH
    • Exemption from Patent Infringement During Clinical Trials
    • Non-Patent Market Exclusivity
    • Hatch-Waxman Patent-Based Exclusivity: Orange Book Listings
    • Patent Reform Gives New Tools to Challenge Patents
    • Biosimilars
    • Patent Term Extensions for Regulatory Delay
    • Disclosure of Clinical Data
  • 14. PROTECTING RESEARCH MATERIALS, RESEARCH RESULTS, AND INVENTIONS: A UNIVERSITY’S PERSPECTIVE
    • Conditions of Patentability, Payment, and Commercialization
    • Confidentiality Agreements
    • Material Transfer Agreements for a Non-profit Institution
    • Useful Resources
    • Exhibit 14-1. Sample Confidentiality Agreements
    • Exhibit 14-2. Simple Letter Agreement (Standardized MTA)
    • Exhibit 14-3. Uniform Biological Material Transfer Agreement
    • Exhibit 14-4. Sample Invention-Report Disclosure Form
    • Exhibit 14-5. Sample License Agreement: Biological Materials for Licensee’s Internal Use
  • 15. RESEARCH PRIVACY ANDSECURITY
    • Federal Privacy Rules
    • State Privacy and Mandatory Disclosure Laws
    • Electronic Records and Signatures
    • Information Security and Human Research
    • Exhibit 15-1 HIPAA Authorization Exceptions for Research
    • Exhibit 15-2 Sample Data Use Agreement
    • Exhibit 15-3 Compliance Checklist for 21 C.F.R. Part 11: FDA Electronic Signature Mandates
  • 16. INTERNATIONAL REGULATION AND GLOBAL ETHICS IN CLINICAL RESEARCH
    • U.S. Federal Standards for Research in Foreign Countries
    • International Standards for Human Subject Protections and Clinical Research Ethics
    • Beyond Regulations: Ethics in Cross-Cultural Contexts
    • Concluding Considerations: Cultural Competence and Social Projection
  • 17. GDPR COMPLIANCE CONSIDERATIONS
    • Overview of GDPR Compliance
    • Status and Implementation
    • Personal Data and Processing
    • Territorial Scope of Application
    • Enforcement and Fines
    • Obligations for Controllers and Processors
    • Rights of Data Subjects
    • Transfer of Personal Data
  • Glossary
  • Table of Cases
  • Index
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