Case Report Form (CRF) as source data [Regulatives / Guidelines]

posted by Ohlbe – France, 2024-06-24 12:54 (23 d 15:00 ago) – Posting: # 24034
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Dear Mais,

❝ We utilize the Case Report Form (CRF) as source data, which we define in the Bioequivalence (BE) study protocol.


If the CRF is used as source, section 4.9.0 applies to it: you need to follow the ALCOA+ principles, including for changes to data, which should be traceable, should not obscure the original entry, and should be explained if necessary.

Regards
Ohlbe

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