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krish ☆ India, 2015-07-15 09:05 (3205 d 22:33 ago) Posting: # 15082 Views: 5,607 |
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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 |
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ajay_783 ☆ India, 2015-07-20 13:54 (3200 d 17:44 ago) @ krish Posting: # 15107 Views: 4,546 |
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Dear Krish, We would appreciate if you can mention at which stage of study execution the said error was realised? Regards, Dr. Ajay Malle |
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ElMaestro ★★★ Denmark, 2015-07-20 14:07 (3200 d 17:31 ago) @ krish Posting: # 15108 Views: 4,542 |
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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 |
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krish ☆ India, 2015-07-27 12:17 (3193 d 19:21 ago) @ ElMaestro Posting: # 15148 Views: 4,340 |
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Hi ElMaestro: It is in a bioequivalence study and after the execution of clinical Phase. Regards, KRISH.. |
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BE-proff ● 2015-07-28 01:07 (3193 d 06:31 ago) @ krish Posting: # 15156 Views: 4,283 |
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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  |
Ing. Helmut Schütz