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

posted by Mais – Jordan, 2024-06-25 08:06 (22 d 19:39 ago) – Posting: # 24036
Views: 662

Dear Ohlbe,
Thank you for your response. We adhere to ALCOA+ principles during the completion of CRFs. In this scenario, is it possible to consider Section 8.3.15 from GCP-R2, which pertains to the Documentation of CRF corrections, as not applicable? This is because, in contrast to situations where the CRF is not utilized as a source, 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 trust my question is clear.
Thank you.

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