The Role and Responsibilities of the Study Director in GLP Studies [electronic resource] /
Organisation for Economic Co-operation and Development.
Organisation for Economic Co-operation and DevelopmentContributor
Paris : OECD Publishing,
1999.
This document defines the roles and responsibilities of the Study Director in Good Laboratory Practice studies.
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
This document defines the roles and responsibilities of the Study Director in Good Laboratory Practice studies.
Bibliographic Level Mode of Issuance: Monograph
Environment
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring