Confirmation reporting

[Chris Robbie]

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

[Chris Robbie]

Could I also request that when submitting a Confirmation report it is of the standard expected by the BSQR and subsequent requirements of the Good Practice Guide

- Contain all relevant detail of SAEs
- identifies the RC, i.e. WHY the event occurred and not just an account of how
- that the CAPA addresses the RC and all human factors identified, i.e. the process, procedural and system errors involved
- if human error is suspected as the cause that must be JUSTIFIED having ruled out process, procedural and system errors
- This detail must be included in the report

Remember, you are submitting a report. Any reports which only contain a few lines of information are likely to be returned for Footnote with more information.

Thanks for your co-operation.

Chris