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joy_fm ☆ Indonesia, 2014-06-10 05:00 (3988 d 06:06 ago) Posting: # 13047 Views: 5,902 |
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Dear all, I couldn't find breaking code procedure in EMEA Guideline. Could we open randomization code without attendance of sponsor ? Could we open randomization code only with Statistician and Principal Investigator ? And why ? Best Regards joy_fm |
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ElMaestro ★★★ Denmark, 2014-06-10 12:56 (3987 d 22:10 ago) @ joy_fm Posting: # 13048 Views: 4,897 |
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Hi Joy_fm, ❝ I couldn't find breaking code procedure in EMEA Guideline. Could we open randomization code without attendance of sponsor ? Could we open randomization code only with Statistician and Principal Investigator ? And why ? As far as I know there are no detailed rules. In practice most companies define a "database" (another aspect which isn't covered by ICH E6 and other documents) that holds all the results and is open to input up to a certain point after LPO. Once the SAP has been signed (it sometimes is already at the approval stage of the protocol) and all queries have been resolved the raw data are final and the database is locked. At this point the code can be safely broken and the primary and secondary analyses executed. If your QMS is mature the trial outcome is almost entirely tamper-free that way. Not sure why the PI or sponsor could care much about being present when the code is open, but surely the statistician would appreciate being let in on the big secret sooner or later  — Pass or fail! ElMaestro |
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joy_fm ☆ Indonesia, 2014-06-10 15:37 (3987 d 19:29 ago) @ ElMaestro Posting: # 13049 Views: 4,767 |
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Hi ElMaestro, thank you for your information. I'm still curious about common practice in many CROs regarding opening randomization code procedure,,, Best Regards Joy_fm |
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ElMaestro ★★★ Denmark, 2014-06-10 21:37 (3987 d 13:28 ago) @ joy_fm Posting: # 13051 Views: 4,826 |
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Hi Joy_fm, it always starts with an SOP. The CROs have an SOP in place which describes who has access to the randomisation code and when (and how) and which lays out a way to document that access for every trial. — Pass or fail! ElMaestro |
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joy_fm ☆ Indonesia, 2014-06-12 05:00 (3986 d 06:06 ago) @ ElMaestro Posting: # 13062 Views: 4,734 |
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Hi ElMaestro, Yes, I absolutely agree with you : "It always start with SOP". We already have SOP for that,,, Actually, we want to change the content of it, but we are not sure if the changes is allowed or not. Hopefully, I can get more information about opening randomisation code from this forum,,, Thank you so much joy_fm |
Ing. Helmut Schütz