Bioequivalence and Bioavailability Forum

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).