Randomization access [Regulatives / Guidelines]
Hi bkrao,
Usually, BE studies are open-label and control of the rand. code is thus not extremely crucial, but it is a good habit in the industry to keep the rand. code away from bioanalysts. Most companies I know of state that bioanalysts are actually kept blind, both in protocols and SOPs. I think this is a very healthy principle but it is not specifically regulated by a guideline.
❝ My question is whether the treatment randomization is accessable to the bioanalytical persons before the intioation of the bioanalytial phase.
Usually, BE studies are open-label and control of the rand. code is thus not extremely crucial, but it is a good habit in the industry to keep the rand. code away from bioanalysts. Most companies I know of state that bioanalysts are actually kept blind, both in protocols and SOPs. I think this is a very healthy principle but it is not specifically regulated by a guideline.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Randomization access bkrao 2015-08-10 07:24 [Regulatives / Guidelines]
- Randomization access BE-proff 2015-08-10 08:38
- Randomization access bkrao 2015-08-10 08:51
- Randomization access BE-proff 2015-08-10 09:41
- Randomization accessElMaestro 2015-08-10 09:51
- Randomization access bkrao 2015-08-10 10:18
- Result oriented? Analyst driven? ElMaestro 2015-08-10 10:53
- Result oriented? Analyst driven? bkrao 2015-08-10 13:22
- Relax Helmut 2015-08-10 18:33
- Thanks you bkrao 2015-08-11 05:44
- Relax Helmut 2015-08-10 18:33
- Result oriented? Analyst driven? bkrao 2015-08-10 13:22
- Result oriented? Analyst driven? ElMaestro 2015-08-10 10:53
- Randomization access bkrao 2015-08-10 10:18
- Randomization access bkrao 2015-08-10 08:51
- Randomization access Ohlbe 2015-08-17 18:14
- Randomization access BE-proff 2015-08-10 08:38