Study Monitor [Regulatives / Guidelines]

posted by drgunasakaran1  – 2012-06-12 09:19 (5128 d 12:59 ago) – Posting: # 8692
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Dear Mr Constantinos,

❝ During the conduct of a BE study is it allowed for the Study Monitor to be present and participate in any activity or not?


Yes. The Study monitor can be present and monitor the study activities during BE study execution phase.

❝ Is there a specific guideline addressing this issue?

See here, 5.18 Monitoring section, ICH E6 (R1), Guideline for Good Clinical Practice

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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