Details

Autor(en) / Beteiligte

• Organisation for Economic Co-operation and Development

Titel

The Role and Responsibilities of the Study Director in GLP Studies [electronic resource]

Beschreibungen/Notizen

• Bibliographic Level Mode of Issuance: Monograph
• 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.
• English