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suchit_bhavsar ★ India, 2012-06-05 09:26 (5124 d 22:53 ago) Posting: # 8660 Views: 7,185 |
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Hello to all, We had conducted pivotal study on 50 subjects. On the day of check in we had presented ICFs to 55 volunteers. Out of them few volunteers found alcohol positive and positive for urine drug scan of abuse. So if they (Alcohol poitive and urine drug scan poitive volunteers) are asking for the ICF copies (They had signed) so it is mandatary to give copy of it to them ? Regards, Suchit Bhavsar |
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drgunasakaran1 ★★  2012-06-05 12:13 (5124 d 20:05 ago) @ suchit_bhavsar Posting: # 8661 Views: 6,125 |
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Dear Mr Suchit Bhavsar, We must provide the copies of the Signed ICF to the subjects as per the DCGI's Rule and the subject should sign in the "Issuance of ICF copy Form" after receiving the copy of the ICF. Quote from 3rd Amendment, Drugs and Cosmetics, 2011, Page no 11 of 13. Copies of the Patient Information Sheet and duly filled Informed Consent Form shall be handed over to the subject or his/her attendant also. Reference — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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Dr_Dan ★★ Germany, 2012-06-05 18:41 (5124 d 13:38 ago) @ drgunasakaran1 Posting: # 8665 Views: 6,111 |
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Dear Suchit Bhavsar, You have to give them a copy but you keep the original. You need the original since the subjects were already screened (if I understood right) and for screening a signed ICF is mandatory. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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kaushik089 ★ India, 2012-06-12 10:43 (5117 d 21:35 ago) @ Dr_Dan Posting: # 8695 Views: 6,017 |
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Dear Suchit Bhavsar why dont you guys perform alcohol & DOA screening before presenting ICF? Depending upon the results u can give ICF to that batch that will be easy rather wasting so much of time.  correct if am wrong. kaushik panigrahi. |
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kaushik089 ★ India, 2012-06-12 10:56 (5117 d 21:23 ago) @ kaushik089 Posting: # 8696 Views: 6,021 |
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Dear, dr_dan & dr_gunasakaran, Do we require to have any additional document stating that why the volunteer is actually wanted to 'QUIT' after signing ICF copy? I mean following the above post when the volunteer has 'passsed' DOA and alcohol screening & wanted to quit voluntarily based on the safety issues or may be in any case? let me elaborate the situation. The volunteer reg no will be already documented in the drugs of abuse and alcohol screening CRF then if the same volunteer wants to withdraw what can be the justification for such situations. is there any additional documentation required stating why the volunteer wanted to quit the study????  thanks in advance, kaushik panigrahi. |
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drgunasakaran1 ★★ 2012-06-13 18:15 (5116 d 14:03 ago) @ kaushik089 Posting: # 8729 Views: 5,985 |
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Dear Mr Kaushik panigrahi, ❝ is there any additional documentation required stating why the volunteer wanted to quit the study???? Yes. You need to document the reasons for withdrawal. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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suchit_bhavsar ★ India, 2012-06-12 13:00 (5117 d 19:18 ago) @ kaushik089 Posting: # 8699 Views: 6,044 |
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Dear Mr. kaushik panigrahi. DOA and alcohol can be performed before ICF presentation if mentioned in the screening informed consent form. When it is a part of the study it sholud be performed after the study ICF only. Regards, Suchit Bhavsar Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
Ing. Helmut Schütz