sri
☆    

2010-02-22 08:22
(5556 d 14:14 ago)

Posting: # 4800
Views: 5,187
 

 Informed consent form [GxP / QC / QA]

Dear all,
I have a small doubt regarding the informed consent form used in clinical trails prior to screening tests. That is whether the leagally accepted representative who signed in others informed consent can participate in the same study as another volunteer?

Please clarify my doubt as early as possible.

Thanks in advance.

Regards,
Sri
Jaime_R
★★  

Barcelona,
2010-02-22 08:47
(5556 d 13:49 ago)

@ sri
Posting: # 4801
Views: 4,183
 

 Informed consent form

Dear Sri!

❝ [...] the leagally accepted representative who signed in others informed consent can participate in the same study as another volunteer?


I'm not sure whether I got yor question right. Are you talking about an impartial witness? If yes, the answer is no (see this thread).

Regards, Jaime
raghu
★    

India,
2010-02-22 12:58
(5556 d 09:38 ago)

@ sri
Posting: # 4806
Views: 4,132
 

 Informed consent form

Dear Sri,

❝ I have a small doubt regarding the informed consent form used in clinical trails prior to screening tests. That is whether the leagally accepted representative who signed in others informed consent can participate in the same study as another volunteer?


❝ Please clarify my doubt as early as possible.


Yes, ICH-GCP does not specify to exclude LAR

But you can not include impartial witness in a clinical trail, where he/she given consent as a impartial witness

Regards

Raghavender Chenna
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