By Deborrah Norris
“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.”
— Journal of Hospital Librarianship
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
2019 | 168 pages/softbound | ISBN: 978-1-940091-05-1
Ebook Editions are available.