Confirmation reporting

Following a number of individual questions and observations, I am posting this message. The requirements under the BSQR are to report all relevant information “as soon as known” and to submit your “proposed” CAPA. Therefore once the RC and CAPA of all individual SAEs is determined then SABRE Confirmation is required. Any additional action that comes from PRIRF can be added to individual reports via Footnotes, but if this does happen then you would need to investigate why the original SAE investigation did not uncover the RCs at the time as the requirement is to identify all system and procedural improvements as part of the initial investigation.

Thanks

Chris