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RegisterAdverse Event Reporting [Regulatives / Guidelines]
At our place as per Data Management team consider these as two different events and is saying that it is in accordance with industrial proctice worldwide, so please help me and answer following questions.
In CRF how would this be captured (ideally)-
1) will the mild episode have a stop date and 'outcome' as resolved and moderate is captured with the same start date as stop date of milder version
OR
2) only stop date is captured and 'outcome' as not resolved and moderate episode on other page
OR
3) Neither stop date nor outcome is captured and moderate episode is captured on other page in continuation to mild one.
Thanks,
Such
In CRF how would this be captured (ideally)-
1) will the mild episode have a stop date and 'outcome' as resolved and moderate is captured with the same start date as stop date of milder version
OR
2) only stop date is captured and 'outcome' as not resolved and moderate episode on other page
OR
3) Neither stop date nor outcome is captured and moderate episode is captured on other page in continuation to mild one.
Thanks,
Such
Complete thread:
- Adverse Event Reporting such 2008-09-09 14:37 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adverse Event Reporting Ohlbe 2008-09-09 17:14
- Adverse Event Reportingsuch 2008-09-10 08:46
- Adverse Event Reporting Ohlbe 2008-09-10 10:30
- Adverse Event Reporting such 2008-09-10 11:42
- Adverse Event Reporting Ohlbe 2008-09-10 11:56
- Adverse Event Reporting such 2008-09-10 11:42
- Adverse Event Reporting Ohlbe 2008-09-10 10:30
- Adverse Event Reportingsuch 2008-09-10 08:46
- Adverse Event Reporting Ohlbe 2008-09-09 17:14
Ing. Helmut Schütz