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Clinical Research Compliance Manual: An Administrative Guide

By Patricia Brent, 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 in compliance program development, auditing and monitoring

Clinical Research Compliance Manual has been updated to include:

  • A new chapter on "Protecting Research Materials, Research Results, and Inventions: A University's Perspective"
  • A new section on "Recent Proposed Changes to the Common Rule"
  • Updated discussion of federal-wide assurance (FWA)
  • OHRP's revision of its FAQs to be consistent with its Final Guidance on Engagement of Institutions in Human Subject Research
  • Recent OHRP guidance on when institutions are not engaged in human subject research
  • And much more!

 

 

Resources Highlight
Last Updated 10/13/2017
Update Frequency Updated annually
Product Line Wolters Kluwer Legal & Regulatory U.S.
ISBN 9780735569669
SKU 10045302-7777
Resources Highlight
Product Line Wolters Kluwer Legal & Regulatory U.S.
SKU 000000000010048339
Table of Contents
  • 1. OVERVIEW OF CLINICAL RESEARCH PRINCIPLES AND REGULATORY ENVIRONMENT
    • Background of Human Subject Protection and Sources of Ethical Guidance
    • 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
    • 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
    • Guidances on Human Subject Protections
    • Exhibit 2-1 Guidance on Engagement of Institutions in Human Subject Research
    • Exhibit 2-2 OHRP Correspondence, Jan. 13, 2009: Determining When Institutions Are Engaged in Research
    • Exhibit 2-3 Final Rule: Institutional Review Boards: Registration Requirements
    • Exhibit 2-4 Comparison of FDA and HHS/OHRP Human Subject Protection Regulations
    • Exhibit 2-5 Glossary of Terms for 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
    • Exhibit 3-1 71 Fed. Reg. 32,827-32,834 (June 7, 2006)
    • Exhibit 3-2 Office for Human Research Protections: Applicability of 45 C.F.R. Part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 C.F.R. §50.23(e)
  • 4. INSTITUTIONAL REVIEW BOARDS: THEIR ROLE AND RESPONSIBILITIES IN CLINICAL RESEARCH PROGRAMS
    • Regulatory Structure of IRBs
    • Registration of IRBs—HHS/OHRP
    • Criteria for Approval of Research—HHS/OHRP
    • Conduct of IRB Review—HHS/OHRP
    • Unanticipated Problems, Adverse Event Reporting, and Protocol Deviation/Violation—HHS/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 on Continuing Review
    • Exhibit 4-3 Examples of Adverse Events That DoNot Represent Unanticipated Problems and Do Not Need to Be Reported Under the HHS Regulations at 45 C.F.R. Part 46
    • Exhibit 4-4 Examples of Adverse Events That Represent Unanticipated Problems and Need to Be Reported Under the HHS Regulations at 45 C.F.R. Part 46
    • Exhibit 4-5 Examples of Unanticipated Problems That Do Not Involve Adverse Events and Need to Be Reported Under the HHS Regulations at 45 C.F.R. Part 46
    • Exhibit 4-6 Algorithm for Determining Whether an Adverse Event Is an Unanticipated Problem
    • Exhibit 4-7 Guidance on Reporting Incidents to OHRP
    • Exhibit 4-8 Guidance for Institutional Review Boards and Clinical Investigators
    • Exhibit 4-9 IRB Reviewer Checklist: Children as Research Subjects
    • Exhibit 4-10 IRB Reviewer Checklist: Prisoners as Research Subjects
    • Exhibit 4-11 IRB Reviewer Checklist: Pregnant Women, Fetuses, and Newborns as Research Subjects
    • Exhibit 4-12 Glossary of Terms
    • Exhibit 4-13 Frequently Asked Questions About the Protocol Registration System
    • Exhibit 4-14 Data Elements for Interventional Trials
    • Exhibit 4-15 Quickguide to Facilitated Review
    • Exhibit 4-16 CIRB Procedure
    • Exhibit 4-17 Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data
    • Monitoring Committees
  • 5. OVERVIEW OF FEDERAL GRANTS ADMINISTRATION
    • What Are Federal Grants?
    • Sources of Law and Policy
    • Overview of Key OMB Circulars
    • Conclusion
  • 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
    • Conclusion
  • 7. KEY GRANTS MANAGEMENT AND ACCOUNTING ISSUES
    • Financial Management Overview
    • Internal Controls
    • Allowable Costs
    • Budget or Project Changes
    • New Issues in NIH Grants Management
    • Conclusion
  • 8. CONFLICT OF INTEREST RULES FOR FEDERALLY REGULATED CLINICAL RESEARCH
    • Defining the Terms and Players
    • Institutional Interests: The Bayh-Dole Act
    • Conflict of Interest Regulations and Guidelines
    • Enforcement: The Federal False Claims Act
    • Association Codes of Conduct
    • Conclusion: Practically Speaking
  • 9. MISCONDUCT IN CLINICAL RESEARCH
    • What Government Agency Oversees Misconduct in Research?
    • The Definition of Research Misconduct
    • The Final Rule Expanded
    • Required ORI Policies and Procedures
    • Role of the Institutional Official
    • Role of Journal Editors and Peer Reviewers in Detecting and Preventing Research Misconduct
    • Proving a Finding of Research Misconduct—the Evidentiary Standard
    • The Process for Investigating an Allegation of Research Misconduct
    • Case Summaries
    • Exhibit 9-1 Glossary of Research Misconduct Terms
    • Exhibit 9-2 Requirements for Institutional Policies and Procedures on Research Misconduct Under the New PHS Policies on Research Misconduct, 42 C.F.R. Part 93
    • Exhibit 9-3 Sample Provisions for Institutional Policies and Procedures on Research Misconduct
    • Exhibit 9-4 Research Misconduct Policy Checklist
    • Exhibit 9-5 Sample Research Misconduct Policy
    • Exhibit 9-6 42 C.F.R. Part 93—Public Health Policies on Research Misconduct, Final Rule
  • 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 Draft Guidance on Important Considerations for When Participation of
    • Human Subjects in Research Is Discontinued
    • Exhibit 10-2 Clinical Trial Documentation Checklist
    • Exhibit 10-3 GCP Checklist: Assessing the Health of Your Institution
    • Exhibit 10-4 Proposed Rule: Reporting Information Regarding Falsification of Data, 75 Fed. Reg. 7412
    • (Feb. 19, 2010)
  • 11. KEY CONCEPTS IN REIMBURSEMENT FOR CLINICAL TRIALS
    • Medical Research Issues Relevant for Reimbursement Considerations
    • Reimbursement Rules
    • Enforcement Activities
    • Exhibit 11-1 Glossary of Terms
    • Exhibit 11-2 States with Legislation Affecting Clinical Trial Reimbursement
    • Exhibit 11-3 NCD for Routine Costs in Clinical Trials
    • Exhibit 11-4 Final Decision for Clinical Trial Policy Q's and A's
    • Exhibit 11-5 NCD with Data Collection
    • Exhibit 11-6 CMS Tracking Sheet
    • Exhibit 11-7 CMS Decision Memo (Oct. 17, 2007)
  • 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
    • Exhibit 12-5 70 Fed. Reg. 71,312-71,320 (Nov. 28, 2005)
    • Exhibit 12-6 OIG NEWS: NSTC Launches Government-wide Initiative Based on OIG Draft Guidance for HHS Research Grants
  • 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 Term Extensions for Regulatory Delay
    • Disclosure of Clinical Data
    • Conclusion
  • 14. RESEARCH PRIVACY ANDSECURITY: MYTHS, FACTS AND PRACTICAL APPROACHES
    • Federal Privacy Rules
    • State Privacy and Mandatory Disclosure Laws
    • Electronic Records and Signatures
    • Information Security and Human Research
    • Conclusion
    • Exhibit 14-1 HIPAA Authorization Exceptions for Research
    • Exhibit 14-2 Sample Data Use Agreement
    • Exhibit 14-3 Compliance Checklist for 21 C.F.R. Part 11: FDA Electronic Signature Mandates
  • 15. 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
  • Table of Cases
  • Index
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