Clinical research coordinator handbook /
Na minha lista:
| Autor principal: | |
|---|---|
| Formato: | Livro |
| Idioma: | English |
| Publicado em: |
Medford, NJ :
Plexus Pub.,
c2009.
|
| Edição: | 4th ed. |
| Assuntos: | |
| Acesso em linha: | Visit NHRC Library |
| Tags: |
Adicionar Tag
Sem tags, seja o primeiro a adicionar uma tag!
|
Sumário:
- 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.