krish
☆    

India,
2014-09-05 14:56
(3492 d 07:33 ago)

Posting: # 13461
Views: 1,513
 

 Consent process [Regulatives / Guidelines]

Dear All,

As per ICH one of the element in Informed consent if

The subject’s responsibilities.


Can any one please tell me what type of subjects responsibilities should be included.

Thanks in advance

Regards,

KRISH.:-)
drgunasakaran1
★★  
avatar

2014-09-14 14:32
(3483 d 07:57 ago)

@ krish
Posting: # 13505
Views: 962
 

 Consent process

Dear Mr Krish,

❝ Can any one please tell me what type of subjects responsibilities should be included.


The Subject's responsibilities to be captured in the Informed consent process includes the following (but not limited to):
  1. Adhering to the study procedures
  2. Informing the Investigator about the occurrence of any Adverse events
  3. Informing the Investigator about the intake of any other OTC or concomitant medications

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
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