Randomization access [GxP / QC / QA]

posted by Ohlbe – France, 2019-08-16 11:28 (630 d 07:16 ago) – Posting: # 20498
Views: 1,261

Dear Akash,

» As per WHO randomization should be accessible to pharmacist and statistician only.
» QA dept independent from other. Does it applicable to QA department?

In general, access to the randomisation list should be restricted on a "need to know" basis: only those persons who really need the list should have access to it, and only when they need it.

Regarding QA, the person doing an in-process audit of the dispensing of the investigational products should have access to the list for the purpose and for the duration of the audit. This does not mean that all persons within the QA department should have access to the list at all times.

Regards
Ohlbe

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