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RegisterInformed Consent and Adverse events [GxP / QC / QA]
Dear Yogesh,
If I were to decide, I would list all possible AEs with their percentage in the Protocol and ICF, because on ehtical grounds a company conducting trials on healthy human subjects is supposed to provide every minute details that is available for the product, and if not described in ICF and with even minor chances of occurrence during the study may lead to gross ethical negligence.
Opinion from other members welcome
Regards
Chirag
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
If I were to decide, I would list all possible AEs with their percentage in the Protocol and ICF, because on ehtical grounds a company conducting trials on healthy human subjects is supposed to provide every minute details that is available for the product, and if not described in ICF and with even minor chances of occurrence during the study may lead to gross ethical negligence.
Opinion from other members welcome
Regards
Chirag
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Complete thread:
- Informed Consent and Adverse events yogesh1004 2012-10-09 06:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Informed Consent and Adverse eventscakhatri 2012-10-09 07:38
- Informed Consent and Adverse events yogesh1004 2012-10-10 06:29
- Informed Consent and Adverse events drgunasakaran1 2012-10-09 20:24
- Informed Consent and Adverse events yogesh1004 2012-10-10 06:30
- Informed Consent and Adverse eventscakhatri 2012-10-09 07:38
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