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Johanne
Junior

Canada,
2018-08-02 00:31

Posting: # 19125
Views: 542
 

 Bioanalysis discontinued subject [Regulatives / Guidelines]

Hello,

Since I've started to work with BE, I've always seen in protocol that bioanalysis was required to be performed for samples of subject discontinued due to AE or emesis, but could be omitted for subjects discontinued for other reasons. I'm looking for the specific guidance (EMA, FDA) related to this requirement. Can someone help ?

Joe
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-08-02 02:02

@ Johanne
Posting: # 19126
Views: 668
 

 Bioanalysis discontinued subject

Hi Joe,

I’m not aware of any guidance covering such a case. For my personal opinion see this post. Sometimes volunteers withdraw consent “for personal reasons” not reporting AEs (being afraid that they will not be recruited for another study). The budget of the study covers analysis of all samples – so why not analyze them?

Cheers,
Helmut Schütz
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ElMaestro
Hero

Denmark,
2018-08-02 11:14

@ Johanne
Posting: # 19127
Views: 849
 

 Bioanalysis discontinued subject

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However, I recall a case where the authority interpretation of a withdrawn consent was that if a trial subject withdraws her consent, then it implicitly also implies that she withdraws her permission for the CRO to touch the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.

if (3) 4

Best regards,
ElMaestro

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