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Post by 851999 on Aug 13, 2020 17:32:09 GMT 5.5
Hey.. If a investigational study drug was administered to the wrong patient (2 years child) who is not enrolled in study, how will we report the case? And subjects mother dosed child erroneously |
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Post by 741084 on Aug 13, 2020 17:33:47 GMT 5.5
Interesting query... It can be anybody... 2 year old, or even any other family member. We still need to report an adverse event for pediatric exposure and keep monitoring the child for long time. Who knows if we come across an unexpected benefit 😊. We are in the era of PIP...also evaluate - did mother miss her dose, as a result? Blinding may be a challenge as the child does not have any patient number.
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Post by 851999 on Aug 13, 2020 17:34:24 GMT 5.5
The information about missing dose is not yet provided.. The child has been admitted to the hospital..
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Post by 080088 on Aug 13, 2020 17:36:54 GMT 5.5
Case will be created for child stating medication error - if there is SAE due to wrong administration of drug - no need to report !!
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Post by 190686 on Aug 13, 2020 18:34:02 GMT 5.5
Hey.. If a investigational study drug was administered to the wrong patient (2 years child) who is not enrolled in study, how will we report the case?
And subjects mother dosed child erroneously If i remember correctly... This should become a spontaneous case... I am yet to find the appropriate reference in the regulatory documents... |
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Post by 851999 on Aug 13, 2020 18:35:02 GMT 5.5
But its investigational drug and has not been approved yet
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Post by 190686 on Aug 13, 2020 18:35:34 GMT 5.5
Yes... That is why i am searching for the appropriate guidance documents...
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Post by 851999 on Aug 13, 2020 18:36:07 GMT 5.5
Yes please.. Please tell me the document name so that i will also search..
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Post by 190686 on Aug 13, 2020 18:36:43 GMT 5.5
I am searching with this scenario... I am yet to find the document..
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Post by 190686 on Aug 13, 2020 18:36:56 GMT 5.5
J&J has a very good document on such case scenarios... Anyone from such project... Kindly share your opinion...
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Post by 190686 on Aug 13, 2020 18:37:05 GMT 5.5
EMA GVP Module VI does not cover ADR from IMP... "It is therefore excluded from the scope of this Module, even if the clinical trial where the suspected adverse reaction occurred is a post-authorisation safety..."
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