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Registerchanged assessment [Regulatives / Guidelines]
Dear Dan,
This was a very good comment; I completely understand what makes you say what you do, however, try for a second to put yourself in the shoes of a regulator.
You have a boss to please, and if there is something bosses do not like then it is when their assessors do something that ends up in a referral. Even worse, in some countries the reg.authority can be dragged into court for approving something the originator doesn't like and that actually does happen nowadays when parts of AR's are public. Being a young assessor questioned by a team of overpaid lawyers in suits plus a judge and asked to justify a deviation from a guideline is not exactly a picnic, so I've been told.
Therefore, if the guideline says you must be within 0.8000 to 1.2500 or whatever and you have 0.7991 to 1.0363 etc then although the assessor is convinced there might not be any particular problem with that, his/her boss my not allow a positive assessment. The risk of a resource-draining referral or court case may simply outweigh any other benefit in the mind of the boss.
Best regards
EM.
❝ Thank you very much for this discussion. As you see the problem is more complicated as you would expect on the first glance. To my experience the assessors are more strikt regarding the guidelines and the worst thing is that they will not discuss with you. Either you fullfil the requirements or not and in this case you will have no chance regardless of clinical significance. My intention was to make you sensitive to a changed assessment by the regulatory authorities.
This was a very good comment; I completely understand what makes you say what you do, however, try for a second to put yourself in the shoes of a regulator.
You have a boss to please, and if there is something bosses do not like then it is when their assessors do something that ends up in a referral. Even worse, in some countries the reg.authority can be dragged into court for approving something the originator doesn't like and that actually does happen nowadays when parts of AR's are public. Being a young assessor questioned by a team of overpaid lawyers in suits plus a judge and asked to justify a deviation from a guideline is not exactly a picnic, so I've been told.
Therefore, if the guideline says you must be within 0.8000 to 1.2500 or whatever and you have 0.7991 to 1.0363 etc then although the assessor is convinced there might not be any particular problem with that, his/her boss my not allow a positive assessment. The risk of a resource-draining referral or court case may simply outweigh any other benefit in the mind of the boss.
Best regards
EM.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- failed BE study Dr_Dan 2010-06-02 14:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- failed BE study ElMaestro 2010-06-02 22:36
- failed BE study Dr_Dan 2010-06-03 09:21
- there's hope ElMaestro 2010-06-04 01:48
- disagree Dr_Dan 2010-06-04 13:13
- disagree ElMaestro 2010-06-04 15:26
- Disagree and agree Ohlbe 2010-06-05 00:39
- Disagree and agree #2 Helmut 2010-06-05 23:31
- Disagree and agree #2 ElMaestro 2010-06-06 20:31
- Disagree and agree #2 Helmut 2010-06-06 21:43
- Disagree and agree #2 ElMaestro 2010-06-06 22:44
- Disagree and agree #2 Helmut 2010-06-06 21:43
- Disagree and agree #2 ElMaestro 2010-06-06 20:31
- Disagree and agree #2 Helmut 2010-06-05 23:31
- disagree Dr_Dan 2010-06-04 13:13
- there's hope ElMaestro 2010-06-04 01:48
- failed BE study Dr_Dan 2010-06-03 09:21
- failed BE study statistician 2010-06-05 08:43
- Tales of mystery and imagination Jaime_R 2010-06-05 12:07
- SCNR Helmut 2010-06-05 19:27
- changed assessment Dr_Dan 2010-06-08 11:32
- changed assessment Jaime_R 2010-06-08 12:05
- changed assessmentElMaestro 2010-06-08 20:42
- Tales of mystery and imagination Jaime_R 2010-06-05 12:07
- failed BE study ElMaestro 2010-06-02 22:36
Ing. Helmut Schütz