QPPV.COM KNOWLEDGE ASSESSMENT

Knowledge Assessment: PSUR Data Lock Points, Reporting Intervals and Submission Timelines

Test your understanding of the concepts covered by GVP Module VII: PSUR Data Lock Point and Reporting Interval.

Question 1 of 10Pass mark: 80%

Question 1 of 10 How should information received after the DLP generally be handled?

Automatically exclude it from all safety processes Automatically add it to the reporting interval regardless of its date Assess whether it is relevant cumulative information, an important new safety issue or a matter requiring another process Change the DLP for every item received after the cut-off

Question 2 of 10 An MAH has a PSUR with a DLP of 30 June. Which project-planning interpretation is most appropriate?

The final report must be submitted on 30 June The reporting period ends on 30 June, after which the applicable preparation and submission period begins The reporting period begins on 30 June and ends at submission All safety information received after 30 June must be disregarded

Question 3 of 10 Why should the reporting interval not be treated as the product's complete safety history?

A PSUR evaluates only clinical-trial data from the interval A PSUR principally evaluates information arising during the interval while placing it in the context of cumulative knowledge Historical safety information is prohibited from appearing in a PSUR The reporting interval covers only information received after the DLP

Question 4 of 10 For a substance covered by an applicable EURD entry, which source should normally be used to establish the PSUR frequency, DLP and submission date?

The previous PSUR cover page The MAH's historical internal calendar The current applicable EURD list entry The date used by the longest-standing national marketing authorisation

Question 5 of 10 What does appropriate QPPV oversight of PSUR timelines primarily require?

The QPPV must personally maintain every calendar entry The QPPV must write every PSUR section The QPPV must have sufficient visibility of governance, compliance capability and significant schedule risks to ensure appropriate escalation The QPPV may delegate all awareness of PSUR deadlines to Regulatory Affairs

Question 6 of 10 Which set of records provides the strongest evidence that a PSUR timeline is inspection-ready?

A spreadsheet containing only the final submission date The previous PSUR and an email confirming that the current dates appear unchanged The current regulatory source, documented schedule determination, controlled calendar, project milestones, escalations and submission evidence A vendor statement that the report was prepared on time

Question 7 of 10 An MAH learns that its internal calendar has been using the wrong PSUR frequency for several products. What is the most appropriate quality-system response?

Correct only the product currently closest to its deadline Change the calendar without documenting the reason to avoid creating records of the error Correct the affected records, investigate the root cause, assess the wider product impact and document the actions taken Continue the old schedule because changing it could create operational disruption

Question 8 of 10 Several MAHs hold authorisations for products containing the same active substance. What is the most appropriate planning assumption under the EURD framework?

Each MAH may always retain a separate historical reporting cycle The products may be subject to a harmonised active-substance reporting schedule, so each MAH should assess its obligations against the applicable EURD entry Only the MAH with the earliest authorisation prepares a PSUR The active substance is excluded from periodic reporting because multiple MAHs are involved

Question 9 of 10 Why do fixed-dose combinations require a specific regulatory-calendar assessment?

Their PSUR obligations are always determined solely by the oldest component The relevant reporting obligation may concern the combination, so the component substances' schedules cannot be assumed to apply automatically Fixed-dose combinations are never included in periodic reporting The DLP for a combination is always the marketing-authorisation approval date

Question 10 of 10 What is the MAH's responsibility when a contract research organisation or other vendor contributes to PSUR preparation?

The vendor assumes the MAH's regulatory responsibility once the contract is signed The MAH remains responsible for timely and compliant submission and must control the vendor interface The QPPV becomes responsible for the vendor's internal staffing The vendor may determine the applicable EURD schedule

Knowledge Assessment: PSUR Data Lock Points, Reporting Intervals and Submission Timelines

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