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jbainseky

04/17/15 9:17 AM

#215806 RE: Protector #215797

CP - To make it clear, what is wrong with this scenario?

- JB leads team, part of kickoff and questions blinding procedures (doesn't like/agree with the answer)
- KNOWS AND UNDERSTANDS all the procedures, signs all the paperwork etc.
- Decides on her own she will switch A & B arms (maybe 40 out of 41 for one of the arms) but can't tell anyone because SHE KNOWS what she is doing is really wrong and would get her fired.(but if she is successful, trial won't be "ruined")
- Begins doing just that, creating notes to keep track of vial numbers, patient numbers etc.
- At some point SHE makes a mistake affecting some of the patient/product assignments
- Father is sick and she has to take leave of absense but still doesn't tell anyone
- Finken takes over (hey, right near the end of the trial, not much work left) and actually messes things up a LITTLE more because he doesn't know A & B were attempting to be switched by JB
- PPHM runs blood work and notices the inconsistencies, contacts to say WTF?
- CSM digs into details and switches some labels to try and cover tracks
- Deeper investigation by PPHM/CSM uncover what really happened.
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bidrite

04/17/15 10:11 AM

#215827 RE: Protector #215797

Nice sleuthing CP. I'm fairly observant and try to be objective in all things PPHM. You've built a strong case with solid reasoning. Hard to argue against.