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RegisterBioanalysis discontinued subject [Regulatives / Guidelines]
Hi Johanne,
first of all, from a data perspective I agree with what Helmut said.
However, I recall a case where the authority interpretation of a withdrawn consent was that if a trial subject withdraws her consent, then it implicitly also implies that she withdraws her permission for the CRO to touch the un-analysed samples she has given up until the time of consent retraction. This is of course a matter of interpretation, but actually it also makes sense to me.
When it comes to rights of trial subjects there is no reason to take any chances. In this regard we need to think about ICH E6 §2.3 - rights, safety and well-being before science. Other clauses are in play, too.
first of all, from a data perspective I agree with what Helmut said.
However, I recall a case where the authority interpretation of a withdrawn consent was that if a trial subject withdraws her consent, then it implicitly also implies that she withdraws her permission for the CRO to touch the un-analysed samples she has given up until the time of consent retraction. This is of course a matter of interpretation, but actually it also makes sense to me.
When it comes to rights of trial subjects there is no reason to take any chances. In this regard we need to think about ICH E6 §2.3 - rights, safety and well-being before science. Other clauses are in play, too.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Bioanalysis discontinued subject Johanne 2018-08-02 00:31 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioanalysis discontinued subject Helmut 2018-08-02 02:02
- Bioanalysis discontinued subjectElMaestro 2018-08-02 11:14
Ing. Helmut Schütz