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

Case Report Form (CRF) as source data [GxP / QC / QA]

posted by Mais – Jordan, 2024-06-24 09:04 (203 d 15:48 ago) – Posting: # 24033
Views: 2,155

Dear members,
We utilize the Case Report Form (CRF) as source data, which we define in the Bioequivalence (BE) study protocol.
in this case how can we address section 8.3.15 from GCP-R2, Documentation of CRF correction, Can we consider it not applicable in this scenario?

Edit: Category changed; see also this post #1 [Ohlbe]

Complete thread:

Case Report Form (CRF) as source dataMais 2024-06-24 07:04 [GxP / QC / QA]
- Case Report Form (CRF) as source data Ohlbe 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