OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring

ISSN :
2077-785X (online)
DOI :
10.1787/2077785x
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This is the complete set of the series on OECD Principles of Good Laboratory Practice (GLP) which set the quality standards for the organisation and management of test facilities and for performing and reporting studies related to the safety of chemical substances and preparations. The GLP Principles cover all aspects of a laboratory’s daily activity, such as the layout of testing and storage areas to prevent contamination, cleaning and calibration of equipment, handling of test animals, and recording and archiving of test results. The GLP Principles thereby help ensure that studies submitted to regulatory authorities, to notify or register chemicals, are of sufficient quality and rigour and are verifiable.

Also available in: French
 
The Role and Responsibilities of the Study Director in GLP Studies

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Author(s):
OECD
Publication Date :
15 Sep 1999
Pages :
12
ISBN :
9789264078673 (PDF)
DOI :
10.1787/9789264078673-en

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This document defines the roles and responsibilities of the Study Director in Good Laboratory Practice studies.

Also available in: French

Table of Contents

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