joy_fm
☆    

Indonesia,
2014-06-10 05:00
(3580 d 04:08 ago)

Posting: # 13047
Views: 4,801
 

 Breaking Code [Study Per­for­mance]

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
ElMaestro
★★★

Denmark,
2014-06-10 12:56
(3579 d 20:11 ago)

@ joy_fm
Posting: # 13048
Views: 4,024
 

 Breaking Code

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 :-D

Pass or fail!
ElMaestro
joy_fm
☆    

Indonesia,
2014-06-10 15:37
(3579 d 17:31 ago)

@ ElMaestro
Posting: # 13049
Views: 3,929
 

 Breaking Code

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
ElMaestro
★★★

Denmark,
2014-06-10 21:37
(3579 d 11:30 ago)

@ joy_fm
Posting: # 13051
Views: 3,968
 

 It always starts with...

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
joy_fm
☆    

Indonesia,
2014-06-12 05:00
(3578 d 04:07 ago)

@ ElMaestro
Posting: # 13062
Views: 3,900
 

 It always starts with...

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
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