GVP Module VIII: PASS Inspection and Audit Findings

Assign blame → close the record → decide whether evidence is needed Identify the observation → determine the applicable control → examine what occurred and the evidence → assess consequences → correct and verify effectiveness Search for a precedent → classify the issue as an inspection finding → archive the file Rewrite the SOP → retrain staff → assume the issue is resolved

Because imposed PASS reports are never submitted to regulators Because study results may enter a defined regulatory assessment and lead to changes in the marketing authorisation or risk-management activities Because the final report is not part of the pharmacovigilance system Because only internal audit findings can be used for regulatory decision-making

Number of meetings held by the study team Number of pages in the final report Time to escalation of important findings and recurrence of critical deviations Number of employees with access to the study folder

Perform all epidemiological and statistical analyses personally Approve every operational task performed by a vendor Ensure significant study information and safety implications are integrated into the pharmacovigilance system and reach appropriate decision-makers Replace the competent authority's assessment of the study

Relying solely on a signed contract Allowing the CRO to make all scientific decisions without MAH review Documenting qualification, responsibilities, data controls, escalation, review of important analyses and scientific review of conclusions Transferring all pharmacovigilance accountability to the CRO

The risk-minimisation measure was clinically effective The target population experienced the intended reduction in risk An implementation or reach objective was achieved, but effectiveness is not established The measure can be removed from the RMP

Maintaining a complete archive of every study-related document Demonstrating traceability and effective control from the safety question through follow-up action Ensuring that no protocol deviations occur during the study Using the same operational checklist for every type of PASS

The study has no further relevance and can be excluded from future pharmacovigilance activities The result is valuable, but residual uncertainty and implications for the RMP, signal management and future evidence should still be assessed The result automatically proves that the suspected association does not exist No regulatory or pharmacovigilance review is needed once the report is approved internally

Wait until the final report because interim information is outside pharmacovigilance Treat the association as a confirmed regulatory signal immediately Escalate it through a defined pharmacovigilance pathway for assessment Ask the vendor to determine independently whether regulatory action is required

Unplanned analyses are automatically unacceptable The analysis may be appropriate if the change is justified, its impact is assessed and the departure is transparently reported The change should be omitted from the final report if it improves the result Statistical sophistication eliminates the need to document methodological changes