Clinical Research Compliance Manual : An Administrative Guide

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: OHRP's clarification on what it means to be "engaged in research" Discussion of the Final Rule on Informed Consent Elements Discussion of the Expanded Access to Investigational Drugs for Treatment Use provision of the Food and Drug Administration Amendments Act of 2007 Updated discussion of consent litigation and clinical research Discussion of the November 2010 Guidance for IRB Approval of Research with Conditions Discussion of the November 2010 Guidance for IRBs on Continuing Review Clarification of the role of local and central IRBs in multi-center research projects Updated Guidance on IRB Continuing Review of Research Discussion of the 2010 Proposed Rule on the Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors Major Proposed Changes to Public Health Service Financial Conflict of Interest Regulations Discussion of the Guidance on the Withdrawal of Subjects from Research