By Deborrah Norris
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“This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”
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
- Reporting Study Results
July 2019 | 168 pages/softbound | ISBN: 978-1-940091-05-1 | Regular Price: $43.95
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