In this fully revised and expanded fifth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glossary. This book covers these topics and more: Federal Regulations/GCP and ICH Guidelines; Clinical Research Coordinator Responsibilities; Investigator Responsibilities; Obtaining Informed Consent/Assent; Creating and Examples of Source Documents; Electronic Data Capture (EDC); Preparing for Regulatory Inspections; and Reporting Study Results.
