Mais ☆ Jordan, 2024-06-24 09:04 (233 d 16:52 ago) Posting: # 24033 Views: 2,452 |
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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] |
Ohlbe ★★★ France, 2024-06-24 12:54 (233 d 13:02 ago) @ Mais Posting: # 24034 Views: 2,036 |
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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 |
Mais ☆ Jordan, 2024-06-25 08:06 (232 d 17:50 ago) @ Ohlbe Posting: # 24036 Views: 1,915 |
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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. |
Ohlbe ★★★ France, 2024-06-25 19:42 (232 d 06:14 ago) @ Mais Posting: # 24037 Views: 1,965 |
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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 |
Mais ☆ Jordan, 2024-06-26 08:23 (231 d 17:33 ago) @ Ohlbe Posting: # 24039 Views: 1,838 |
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Dear Ohlbe Thank you for your answer Very helpful. Thank you |