Particular attention should be paid to any differences between the planned analysis and the actual analysis as described in the protocol, protocol amendments or the updated statistical analysis plan based on a blind review of data.〔【出典】ICHガイドライン 〕
This opinion has been more credited in our times because of the great changes in affairs which have been seen, and may still be seen, every day, beyond all human conjecture.〔【出典】日英対訳文・対応付けデータ(独立行政法人情報通信研究機構)〕"_PRI2-25", "2536327"
政府はこの情報を信憑性があると見なしている。
The government views this information as credible.
The credibility of the numerical results of the analysis depends on the quality and validity of the methods and software (both internally and externally written) used both for data management (data entry, storage, verification, correction and retrieval) and also for processing the data statistically.〔【出典】ICHガイドライン 〕
Any interim analysis that is not planned appropriately (with or without the consequences of stopping the trial early) may flaw the results of a trial and possibly weaken confidence in the conclusions drawn.〔【出典】ICHガイドライン 〕