Bioequivalence and Bioavailability Forum • Case Report Form (CRF) as source data

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

posted by Ohlbe – France, 2024-06-24 12:54 (373 d 08:42 ago) – Posting: # 24034
Views: 2,960

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

Complete thread:

Case Report Form (CRF) as source data Mais 2024-06-24 07:04 [GxP / QC / QA]
- Case Report Form (CRF) as source dataOhlbe 2024-06-24 10:54
  - Case Report Form (CRF) as source data Mais 2024-06-25 06:06
    - Case Report Form (CRF) as source data Ohlbe 2024-06-25 17:42
      - Case Report Form (CRF) as source data Mais 2024-06-26 06:23