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RegisterInformed Consent and Adverse events [GxP / QC / QA]
Dear Mr Yogesh,
Yes. It is mandatory to document all the adverse events reported in the SmPC/Prescribing Information in the Informed Consent Document.
No. Will not be accepted by the Regulatory Authorities.
❝ Is it is also necessary to document the adverse events reported for that molecule as mentioned in the label in Protocol and Informed consent form?
Yes. It is mandatory to document all the adverse events reported in the SmPC/Prescribing Information in the Informed Consent Document.
❝ Or is it is sufficient to write the adverse events observed with out the study details and percentages.
No. Will not be accepted by the Regulatory Authorities.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
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 events cakhatri 2012-10-09 07:38
- Informed Consent and Adverse events yogesh1004 2012-10-10 06:29
- Informed Consent and Adverse eventsdrgunasakaran1 2012-10-09 20:24
- Informed Consent and Adverse events yogesh1004 2012-10-10 06:30
- Informed Consent and Adverse events cakhatri 2012-10-09 07:38
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