Clinical research coordinator handbook /
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| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Medford, NJ :
Plexus Pub.,
c2009.
|
| Edition: | 4th ed. |
| Subjects: | |
| Online Access: | Visit NHRC Library |
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Table of Contents:
- Federal regulations governing the obligations of clinical investigators of regulated articles
- The clinical research organization
- Investigator responsibilities
- Duties of the clinical research coordinator
- The creation of study source documents
- Obtaining informed consent and assent approval
- Pertinent forms and study records
- The prestudy site visit
- Recruiting and enrolling subjects
- Conducting the study and keeping records
- Preparing for an FDA audit
- Clinical research : potential liability
- Writing the study sumary
- Achieving credibility and recognition as a Clinical Research Coordinator
- Electronic data capture and clinical trials.