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RegisterFabrication of Data [GxP / QC / QA]
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
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
Complete thread:
- Fabrication of Data devender_naik 2007-06-23 21:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fabrication of DataOhlbe 2007-06-29 11:57
Ing. Helmut Schütz