krish
☆    

India,
2015-07-15 09:05
(3179 d 10:38 ago)

Posting: # 15082
Views: 5,486
 

 Informed consent [GxP / QC / QA]

Hello every body,

If suppose any of the essential elements of informed consent is missed during preparation and was identified after the study execution, what action shall be taken, I request you all to let me know the applicable steps to be taken as per GCP.

Thanks and regards,
KRISH
ajay_783
☆    

India,
2015-07-20 13:54
(3174 d 05:49 ago)

@ krish
Posting: # 15107
Views: 4,449
 

 Informed consent

Dear Krish,

We would appreciate if you can mention at which stage of study execution the said error was realised?

Regards,
Dr. Ajay Malle
ElMaestro
★★★

Denmark,
2015-07-20 14:07
(3174 d 05:36 ago)

@ krish
Posting: # 15108
Views: 4,448
 

 Informed consent

Hi Krish,

❝ If suppose any of the essential elements of informed consent is missed during preparation and was identified after the study execution, what action shall be taken, I request you all to let me know the applicable steps to be taken as per GCP.


For one subject or for all subjects in a trial?

Pass or fail!
ElMaestro
krish
☆    

India,
2015-07-27 12:17
(3167 d 07:25 ago)

@ ElMaestro
Posting: # 15148
Views: 4,245
 

 Informed consent

Hi ElMaestro:

It is in a bioequivalence study and after the execution of clinical Phase.


Regards,
KRISH..
BE-proff
●    

2015-07-28 01:07
(3166 d 18:36 ago)

@ krish
Posting: # 15156
Views: 4,182
 

 Informed consent

Hi Krish,

Actually you can do nothing in this situation...
The only thing that is worth doing is to document this finding and take it into consideration for future
At least it will show that you have seen this error.
Be more careful ;-)
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