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A Practical Guide for the Good Laboratory Practice Study Director

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Good Laboratory Practice (GLP) regulations require the appointment of a Study Director by Test Facility Management for each study.

By virtue of the legal status of the Study Director in testifying to the performance, compliance, accuracy and integrity of the conduct of the study, its data and the final report, the role of the GLP Study Director is critical to study integrity and regulatory compliance and potentially the most complex.
This guidance is intended to be read in conjunction with the Organisation for Economic Co-operation and Development (OECD) Series on Principles of GLP and Compliance Monitoring Number 8 (Revised) Consensus Document, “The role and responsibilities of the Study Director in GLP studies". 

The booklet addresses both the Regulatory role of the Study Director, whilst also addressing matters potentially affecting Study Director’s that are not defined by GLP regulation or guidance, but may be imposed by the role and position of the Study Director within a commercial organisation.

1. Introduction
2. OECD GLP definition of a Study Director
3. The single point of control
4. Appointment of the Study Director
5. Qualifications and training of the Study Director
6. Availability
7. Replacement of the Study Director
8. Responsibilities of the Study Director as defined by OECD GLPs
9. Study planning
10. Multi-site studies
11. Study oversight
12. Quality control
13. Reporting of the study
14. Archiving
15. Managing relationships with others

 

 

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

  • BOOK10 for orders of 10 - 19 copies - 25% discount
  • BOOK20 for orders of 20 - 49 copies - 33% discount
  • BOOK50 for orders over 50 copies - 50% discount


This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.


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Guide to the Role and Responsibilities of GLP Management Booklet
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

C0051 GLP for Study Directors, Principal Investigators, Study Staff and Management (21st May 2019 - 22nd May 2019)
C9053 GLP for Study Directors, Principal Investigators, Study Staff and Management (27th Nov 2018 - 28th Nov 2018)
C9054 GLP for Study Directors, Principal Investigators, Study Staff and Management (5th Mar 2019 - 6th Mar 2019)

eLearning Products

Advanced Good Laboratory Practice (GLP) elearning
Introduction to Good Laboratory Practice (GLP) elearning

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