GVP Module VIII: Imposed and Non-Imposed PASS

The QPPV only needs to know whether the study will be published The QPPV should have assurance that significant obligations, safety evidence and resulting actions are effectively controlled The QPPV is responsible for selecting the epidemiological design of every PASS The QPPV's oversight is required only for voluntary studies

Only the study title and name of the CRO Study objective, classification, regulatory basis, RMP relationship, milestones and submission route Only the final results and publication status The scientific design without any regulatory documentation

The report must be labelled final because data collection has ended The study may still require completion of analyses before a scientifically final report can be submitted The study can be closed without reporting the primary results The deadline no longer applies until all analyses are complete

The study CRO alone The MAH's epidemiology department PRAC, except where the applicable Article 22a national route assigns assessment to the relevant national competent authority The marketing-authorisation applicant's clinical trial committee

Within 12 months after the end of data collection Within 12 months after the first patient is enrolled Only when the next PSUR is submitted Immediately when the protocol is approved

An authorisation condition requiring the study A specific obligation established by the applicable regulatory framework A competent-authority request creating the obligation Whether the study is a retrospective database analysis

The study becomes voluntary because the MAH no longer conducts it directly The CRO assumes all regulatory responsibility and the MAH has no further oversight duty The regulatory basis remains unchanged and the MAH must retain oversight of obligations and outcomes The study is no longer subject to imposed-PASS procedures

A study manager's recollection The fact that a CRO was contracted An applicable authorisation condition, specific obligation or competent-authority regulatory request An internal spreadsheet containing the word 'imposed'

Because voluntary studies are legally identical to imposed studies Because safety evidence generated by the study remains relevant to the MAH's pharmacovigilance responsibilities Because every voluntary study automatically creates a specific obligation Because quality controls apply only to studies included in an RMP

To select the most economical database before defining the safety question To determine the applicable governance, submission and change-control framework To avoid conducting a scientific feasibility assessment To ensure that all PASS use an identical study design