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