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Clinical Research Compliance Manual: An Administrative Guide by Lawrence W. Vernaglia ,Patricia Brent Clinical Research Compliance Manual: An Administrative Guide by Lawrence W. Vernaglia ,Patricia Brent

Clinical Research Compliance Manual: An Administrative Guide, Third Edition

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Overview

Clinical Research Compliance Manual: An Administrative Guide, Third Edition

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, flowcharts, checklists, and footnotes to compliance program development, auditing and monitoring

Clinical Research Compliance Manual has been updated to include:

  • Discussion on the revised Common Rule
  • Analysis of enforcement of the May 25, 2018 GDPR
  • New information on HHS’s updated informed consent in human subject research regulations commonly referred to as the “2018 Rules”
  • Updated sections on NIH Supported Clinical Research, including a discussion of recent changes made to the Bayh-Dole Act of 1980
  • Revised sections on the categorization of medical devices as it pertains to reimbursement

And much more!

Previous Edition: Clinical Research Compliance Manual: An Administrative Guide, Second Edition, ISBN 9781543806724

Pages 776
Last Updated 11/18/2019
Update Frequency Annually
Product Line Wolters Kluwer Legal & Regulatory U.S.
ISBN 9781543817553
SKU 10081365-7777
Publish Frequency Annually
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
  • Exhibit 2-1 Registering an IRB and Obtaining an FWA: What to do in What Order

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 Data Elements for Interventional Trials
  • Exhibit 4-2 Quick Guide 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
  • NIH 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
  • Exhibit 9-1 Research Misconduct Policy Checklist
  • Exhibit 9-2 Sample Research Misconduct Policy
  • Exhibit 9-3 Sample Research Integrity Officer’s Responsibilities Policy

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

About The Experts
Volumes