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

posted by Ohlbe – France, 2024-06-25 19:42 (325 d 10:11 ago) – Posting: # 24037
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Dear Mais,

❝ [...] summarizing CRF corrections would require us to examine each page of the CRFs, compile a list of corrections, and then have them double-checked by another quality control individual.


I think you are over-interpreting GCP 8.3.15. What is required is that corrections to the CRF be documented (as described in § 4.9.3), not that a list of such corrections be generated. If corrections are made as described in § 4.9.3 (which would be required to meet the ALCOA+ principles anyway), and you are archiving the corrected CRF pages, then you are achieving what is required in 8.3.15 (To document all changes/additions or corrections made to CRF after initial data were recorded).

Regards
Ohlbe

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