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RegisterData manipulation [GxP / QC / QA]
Dear Mittyri,
No. Simply re-analyse samples of subjects already analysed, under a different subject number. Your T/R is too high ? You want to bring it lower ? Select one previous subject with known expected concentrations, or periods from different subjects (let's say 10 and 14), write everywhere these were the samples of subject 45, and you're done. The first description I have seen of this was made in an inspection report, which somebody obtained under a freedom of information regulation and posted on internet. See document A3 - ANSM Preliminary Report. See also FDA's letter to Semler Research, a few years later.
Well, that French report from 10 years ago already described the general principle. A well-known usual suspect made a detailed publication describing tools and methods.
The problem is not just detecting data manipulation. The problem is collecting enough evidence. If you find signs of data manipulation in one study, you can reject that study. Triggering an article 31 referral to reject all studies from a given CRO probably requires a solid level of evidence. Not just to convince the CHMP: to convince lawyers.
❝ Could you please elaborate how is it possible?
❝ What is the method CRO used for duplication? just copy all concentration points to another subject? what about chromatograms? Did they fake date/time of that?
No. Simply re-analyse samples of subjects already analysed, under a different subject number. Your T/R is too high ? You want to bring it lower ? Select one previous subject with known expected concentrations, or periods from different subjects (let's say 10 and 14), write everywhere these were the samples of subject 45, and you're done. The first description I have seen of this was made in an inspection report, which somebody obtained under a freedom of information regulation and posted on internet. See document A3 - ANSM Preliminary Report. See also FDA's letter to Semler Research, a few years later.
❝ Why experts didn't find it before? Are the methods of data manipulation recognition just implemented?
Well, that French report from 10 years ago already described the general principle. A well-known usual suspect made a detailed publication describing tools and methods.
The problem is not just detecting data manipulation. The problem is collecting enough evidence. If you find signs of data manipulation in one study, you can reject that study. Triggering an article 31 referral to reject all studies from a given CRO probably requires a solid level of evidence. Not just to convince the CHMP: to convince lawyers.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Another one? Helmut 2023-07-19 09:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Confirmed Ohlbe 2023-07-21 12:59
- Who cares? Helmut 2023-07-21 14:24
- Who cares? Ohlbe 2023-07-21 14:39
- Expert Helmut 2023-07-21 14:41
- Who cares? Ohlbe 2023-07-21 14:39
- Questions about data manipulation mittyri 2023-07-22 19:57
- Data manipulationOhlbe 2023-07-22 20:47
- Questions about data manipulation wienui 2023-07-23 17:29
- Questions about data manipulation qualityassurance 2024-04-30 11:38
- Questions about data manipulation Helmut 2024-04-30 11:46
- Questions about data manipulation qualityassurance 2024-04-30 13:55
- Questions about data manipulation Helmut 2024-04-30 14:52
- Assessment report published Ohlbe 2024-06-05 12:45
- Questions about data manipulation Helmut 2024-04-30 14:52
- Questions about data manipulation qualityassurance 2024-04-30 13:55
- Questions about data manipulation Ohlbe 2024-04-30 18:25
- Questions about data manipulation ElMaestro 2024-05-01 07:10
- OT Helmut 2024-05-01 20:42
- Questions about data manipulation Ohlbe 2024-05-01 20:58
- Questions about data manipulation ElMaestro 2024-05-01 07:10
- Questions about data manipulation Helmut 2024-04-30 11:46
- Questions about data manipulation qualityassurance 2024-04-30 11:38
- Update Helmut 2024-03-22 20:29
- Health Canada recalls Helmut 2024-06-09 09:16
- And the FDA… Helmut 2024-06-19 11:22
- Who cares? Helmut 2023-07-21 14:24
- Another one? Ajay Gupta 2023-07-24 04:19
- Confirmed Ohlbe 2023-07-21 12:59
Ing. Helmut Schütz