Bioequivalence and Bioavailability Forum

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