Clinical research coordinator handbook /
محفوظ في:
| المؤلف الرئيسي: | |
|---|---|
| التنسيق: | كتاب |
| اللغة: | English |
| منشور في: |
Medford, NJ :
Plexus Pub.,
c2009.
|
| الطبعة: | 4th ed. |
| الموضوعات: | |
| الوصول للمادة أونلاين: | Visit NHRC Library |
| الوسوم: |
إضافة وسم
لا توجد وسوم, كن أول من يضع وسما على هذه التسجيلة!
|
جدول المحتويات:
- 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.