the basis of T/R in the Pro­tocol [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2014-03-14 16:01 (3667 d 08:44 ago) – Posting: # 12629
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Hi Mittyri,

❝ ❝ If I have information about a larger deviation from a pilot study I use it.

❝ Do you insert any links to the publications about these pilot studies (may be for another market)?


By “pilot” I meant studies the sponsor performed or have access to in an acquired dossier. Only such studies can be assesses for the quality of data (clinical performance, bioanalytics, …). Studies from the literature should be used with caution.

❝ Would you rest the T/R Ratio in the protocol without explanation?


No.

❝ Is it important to the Assessor to know - where do you get this ratio or why are you assuming such ratio?


I think we have to distinguish between assessing the protocol (authority, IEC)* and the report.

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