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kaushik089 ★ India, 2012-06-19 15:19 (5122 d 16:17 ago) Posting: # 8789 Views: 3,001 |
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Hello all, This is the situation at my office with my colleagues which i don't support but i want to clarify, we have given Tamil Telugu & English icf's to a batch of volunteers but the CI who is responsible to obtain these Icf doesn't know Tamil & Telugu languages can he still obtain those ICF'S? EXPERT OPINION REQUIRED. thanks in advance, kaushik panigrahi. |
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Dr_Dan ★★ Germany, 2012-06-19 17:58 (5122 d 13:39 ago) @ kaushik089 Posting: # 8795 Views: 2,464 |
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Dear kaushik panigrahi Please have a look on ICH E6 Guideline on Good Clinical Practice. According to paragraphs 4.8.4 to 4.8.7 the person who is responsible to obtain the informed consent has to explain the study and any risks in the subject's language. If she/he does not know Tamil & Telugu languages she/he has to delegate this responsibility. I hope this helps. Kind regards Dan Edit: Guidance linked. [Helmut] — Kind regards and have a nice day Dr_Dan |
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kaushik089 ★ India, 2012-06-20 12:13 (5121 d 19:24 ago) @ Dr_Dan Posting: # 8815 Views: 2,389 |
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hello dr_dan & others, i agree with u  & the thing is the investigator has already delegated this activity of giving ICF to some other person who is from a medical background(pharma graduate) but he/she is not a doctor but knows the above mentioned languages & also resolved all the questions asked by that volunteers, but finally the ICF has to be obtained by CI right? In documentation part we have two sections were in one section the delegated person will be signing the Icf & obtaining ICF section CI will be signing, So i want to know that if the CI is not familiar with either telugu nor english is he eligible to do that activity of obtaining those ICFs? thanks in advance. regards, kaushik panigrahi. |
Ing. Helmut Schütz