“Spare subjects”, multiple groups [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2015-07-25 22:53 (3492 d 13:43 ago) – Posting: # 15146
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Hi Peregrin,

❝ Should the sponsor explicitly state in the protocol that the study for logistical reasons will be carried out in two or more groups?

❝ If the study has been conducted in several groups without statistical arrangements, should the sponsor at least provide some reasons for not doing so?


Two times yes. Always state in the protocol what you plan to do and why.

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