TRAINEE - World Health Organization

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7. WORKSHOPS – STUDY PLANS / PROTOCOLS There are two workshops dealing with protocols: WORKSHOP 1 The first workshop is based on the protocol review. The protocol concerns a 13-week intravenous study in the rat. Task 1 – is to perform a protocol review. The instructor will provide you with the protocol which has been prepared by a junior study director. As the head of department you are asked to comment on his protocol and to suggest improvements. There are some situations in the protocol that are frankly wrong. The inexperience of the author is evident, and you should be able to correct the protocol where it is deficient and suggest ways in which it can be improved, even in those parts of the document that are compliant Task 2 – is to draw up a fishbone (or Ishikawa) diagram that illustrates the processes of the 13-week study and determines the domains of the major SOPs that apply to the study. Your instructor will explain the Ishikawa model to you before starting the workshop. Your group is asked to report back to a plenary session at the end of the workshop, so it is important to choose a spokesperson(s) at the beginning of the session. The instructor will be available during the workshop to answer your questions and help you if necessary. WORKSHOP 2 The second is based on a different protocol, a study performed in marmosets. The instructor will provide you with the protocol that has certain GLP sections deliberately missing. 131
132 <strong>TRAINEE</strong>S Chapter 7 • GLP Training Manual As study director you are asked to complete the missing parts. Your group is asked to report back to a plenary session at the end of the workshop, so it is important to choose a spokesperson(s) at the beginning of the session. The instructor will be available during the workshop to answer your questions and help you if necessary.
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ABOUT THIS TRAINING MANUAL . . . .
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ABOUT THIS TRAINING MANUAL This man
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1. INTRODUCTION TO THE OECD PRINCIP
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TRAINEE - World Health Organization

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