The Role and Responsibilities of the Study Director in GLP Studies
This document defines the roles and responsibilities of the Study Director in Good Laboratory Practice studies.
| Autor principal: | |
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| Autor Corporativo: | |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Paris :
OECD Publishing
1999.
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| Colección: | OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring,
no.8. |
| Materias: | |
| Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009705155706719 |
Tabla de Contenidos:
- The Role of the Study Director 7 Management Responsibilities 7 -Appointment of Study Directors 8 -Training of Study Directors 8 Responsibilities of the Study Director 8 -Study initiation 8 -Study conduct 9 -Final Report 9 -Archives 10 -Sub-contracting 10 Study Plan Amendments and Deviations 10 -Study Plan Amendment 10 -Study Deviations 10 Qualifications of the Study Director 11 Interface with the Study 11 Replacement of the Study Director 11 Legal Status of the Study Director 12
