schedule time vs. actual time for ANVISA BE [Regulatives / Guidelines]

posted by Relaxation  – Germany, 2022-07-12 15:50 (677 d 19:15 ago) – Posting: # 23127
Views: 2,939

Hello Shuanghe.

I can only add a personal observation from reviews and discussion about a few reports that were going to be submitted to ANVISA.
Basically, the CRO provided both evaluations, one based on actual times and one on scheduled times with an emphasis on that with scheduled times.

When asked why this was done I received a template for the report to be submitted named "Relatorio Estatistico" I was told is a template from ANVISA.
My version here is from 2015 and outdated and I failed to find a newer template on the net (a quick search showed, that this is not a very unique name), but this may still be true.

Therein is a sample table named:
Tabela 4 – Parâmetros primários e secundários ... calculados com base no tempo nominal, referente ao tratamento A.
=> Table 4 - Primary and secondary parameters ... calculated based on the nominal time, referring to treatment A.

I was then told, that this was the root cause for the additional analysis, although we all agreed in the end, that the purpose of such an approach is not fully clear :confused:.

Well, I think that explains nothing, but maybe its a pointer to the origin of this unique requirement for ANVISA.

Best regards!

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