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RegisterAdverse Event Reporting [Regulatives / Guidelines]
Dear Such,
The problem will come mostly if your investigator uses the AE form in the CRF as a source document, with no other record. This is not an easy way to document AEs and their evolution, as the subject will be examined several times, and the form cannot capture information collected each and every time the subject is examined or asked questions. You will have much less trouble if you are using source documents separate form the CRF's AE form. Each time the investigator or study team examine the subject and ask him how he feels, they will enter on these source document the evolution, severity and seriousness of the event. The specific form in the CRF can be completed at a later stage.
There are sometimes different forms in the CRFs for AEs and SAEs. If the investigator started completing an AE form and the AE later evolves to an SAE, it is always possible to switch to the SAE form, and note this on the AE form which had been used initially.
I hope this helps.
Regards
Ohlbe
The problem will come mostly if your investigator uses the AE form in the CRF as a source document, with no other record. This is not an easy way to document AEs and their evolution, as the subject will be examined several times, and the form cannot capture information collected each and every time the subject is examined or asked questions. You will have much less trouble if you are using source documents separate form the CRF's AE form. Each time the investigator or study team examine the subject and ask him how he feels, they will enter on these source document the evolution, severity and seriousness of the event. The specific form in the CRF can be completed at a later stage.
There are sometimes different forms in the CRFs for AEs and SAEs. If the investigator started completing an AE form and the AE later evolves to an SAE, it is always possible to switch to the SAE form, and note this on the AE form which had been used initially.
I hope this helps.
Regards
Ohlbe
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 Reporting such 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 ReportingOhlbe 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 Reporting such 2008-09-10 08:46
- Adverse Event Reporting Ohlbe 2008-09-09 17:14
Ing. Helmut Schütz