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Dear All,
Can any one clarify the following?
How to document, If a subjects develop any un-towards reactions between check-in and dosing of period-I?
As per ICH-GCP adverse event is defined as "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product"
In the above case IP's were not administered.
Thanks in advance
R. Narayana Kumar.
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Dear All
If AE occurs after check-in and before dosing of period-1, one should capture the information in AE form of period-1 and write NA for all the information like relationship to the study medication, last dosing date & time, treatment code and time elapsed since last dosing as in this case IP is not administered.
Further this will be termed as medical complaint and not AE as per ICH-GCP adverse event is defined as "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product"
Best Regards
Dr Muneesh Garg
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It can be reported as medical event in stead of adverse event. Cause, adverse event is the one may or may not be due to drug that means after administration of drug.
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The following message was posted to: PharmPK
You can report it as a medical event.
Adverse effect is after administration of drug.
Regards,
S.Basu
Principal Scientist
Sai Advantium Pharma Ltd.,
Hinjewadi, Pune - 57.
E-Mail : sudipta.b.aaa.saiadvantium.com
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