Justification for the lack of incurred sample reanalysis [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2017-02-14 18:20 (2626 d 06:06 ago) – Posting: # 17058
Views: 2,972

Dear Irene
Please search the forum and you will find a lot of discussion on ISR. The guideline put an expiry date on old studies. If you now submit a study without ISR then this study does not reflect current scientific knowledge and will be certainly rejected. IMHO you can not argue the absence of ISR with 90% confidence interval even if the study result is not borderline.

Kind regards and have a nice day
Dr_Dan

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