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devender_naik ☆ Hyderabad, 2007-06-23 23:19 (6535 d 17:08 ago) Posting: # 830 Views: 5,747 |
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Dear all, Can any one give tell me. where excatly we need to report in case we find any manupulations or fabrication of clinical research relate data. Thank u Dev — dd |
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Ohlbe ★★★ France, 2007-06-29 13:57 (6530 d 02:30 ago) @ devender_naik Posting: # 846 Views: 4,403 |
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Dear Devender, First you should inform the sponsor(s) of the trial(s) where you have found problems... IMHO you should also contact the regulatory authority in charge of overseing (and inspecting) clinical trials in your country. If I understand correctly your "user info" on the forum, you are located in Hyderabad, India, right? I would then suggest to contact CDSCO in Hyderabad (e.g. G. Nageswara Rao, Drugs Inspector, or one of his colleagues) and/or DCGI. If the manipulations or fabrications may have had an impact on the subjects' safety, or if pre- or post-trial safety assessments were not performed and results fabricated, you should also consider informing the Ethics Committee. Regards Ohlbe |
Ing. Helmut Schütz