Stay in Compliance and Protect Your Research Funding! Clinical Research Compliance Manual: An Administrative Guide by Patricia Brent, Lawrence W. Vernaglia List Price: $475.00   Eligible for Free Standard Shipping on U.S. Prepaid Orders Imprint: Aspen Publishers ISBN: 9780735569669 Looseleaf: 588 pages Publication Cycle: Updated annually Last Updated: 7/10/2013 Available: Item ships in 3-5 Business Days

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! View the Highlights for this title. 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 Consent to Treatment: A Practical Guide, Fourth Edition Fay A. Rozovsky Consent to Treatment: A Practical Guide, Fourth Edition is the single-volume, complete library of patient consent topics and solutions. Written by an experienced health care attorney and risk manager, this leading resource helps you formulate your own effective, voluntary and lawful consent poli more... 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