Good Clinical Practice: A Question & Answer Reference Guide - May 2013 - (Page Cover1)

Good Clinical Practice: A QuesTIoN & ANswer reFereNce GuIde MAy 2013 editorial Team: Editor: Michael Hamrell, PhD, RAC, RQAP-GCP, President, MORIAH Consultants Editor Emeritus: Mark Mathieu, PAREXEL International Corporation Plus an all-new 20+ member international Expert Advisory Panel Including: Answers to Hundreds of Frequently Asked Questions Featuring: An All-New Index of Topics Also available in Electronic Format

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2013

Good Clinical Practice: A Question & Answer Reference Guide - May 2013
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials Including the 2013 Omnibus HIPAA Rulemaking
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, India, China, Russia, Ukraine, and Canada
Section 20: GCP Compliance Statistics and Trends (Data on U.S. FDA Inspections)
Index

Good Clinical Practice: A Question & Answer Reference Guide - May 2013