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XEVMPD Data Quality, Reconciliation and Detection of Hidden Errors

Test your understanding of the concepts covered by XEVMPD Data Quality: Reconciliation, Completeness and Detecting Hidden Errors.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which reconciliation approach is most suitable for testing a known risk involving recent marketing-authorisation transfers?

A targeted review of transferred products and related lifecycle fields A sample limited to products with no regulatory changes A comparison based only on commercial sales volume A review of random products with no consideration of transfer history

Question 2 of 10 Which statement best describes the role of controlled terminology in XEVMPD data quality?

Use of a controlled term proves that the value is correct for the product Controlled terminology makes source-data review unnecessary A term must be both permissible in the system and appropriate for the specific medicinal product Only free-text values can create substantive data errors

Question 3 of 10 Which metric would best help identify whether previously addressed control weaknesses are recurring?

Total number of records in XEVMPD Percentage of messages transmitted successfully Repeat finding rate or recurrence by root-cause category Number of products with a commercial launch date

Question 4 of 10 Which evidence package would provide the strongest support for an inspector asking how XEVMPD accuracy is controlled?

A current SOP stating that submissions are made on time A statement that all previous XEVPRMs were accepted A completed reconciliation showing scope, sources, logic, discrepancies, investigations, corrections and verification A list of employees trained on the XEVMPD system

Question 5 of 10 Which example primarily concerns correctness rather than completeness?

An in-scope medicinal product has no XEVMPD record A product is represented twice under different identifiers The XEVMPD pharmaceutical form is a valid controlled term but does not match the authorised product A product was removed from the internal portfolio but remains appropriately represented during a defined transition

Question 6 of 10 A system migration preserved the total number of XEVMPD-related records but changed organisation mappings and product relationships. What is the most appropriate assessment?

The migration was successful because record counts were unchanged The migration requires assessment of whether the meaning, relationships and critical data attributes were preserved Only records added after migration need review The differences are irrelevant if the new system uses a newer interface

Question 7 of 10 Which investigation is most appropriate after identifying a stale MAH following a transfer?

Review only whether the original XEVPRM was accepted Examine how the transfer was captured, communicated, submitted, acknowledged and verified, including potentially affected products Replace the former MAH manually without reviewing the transfer process Close the finding because the original record was accurate at creation

Question 8 of 10 An EMA quality-control activity amends a medicinal-product entity in XEVMPD. What should the MAH consider doing with its local product database?

Ignore the change because only the Agency may maintain the entity Review and retrieve the amended entity information and incorporate appropriate corrections into internal systems before relevant future maintenance Overwrite all local product data with the entire XEVMPD database without assessment Wait until a product generates a safety report before reviewing the amendment

Question 9 of 10 A wrong pharmaceutical-form mapping was applied using a table shared by 500 products. What is the most appropriate next step?

Correct only the identified product because the finding was initially detected there Delete the mapping table and allow users to select terms freely Assess the other products using the same mapping as a potential affected population Conclude that all 500 records are definitely incorrect without further review

Question 10 of 10 Which reconciliation design best addresses completeness at portfolio level?

Compare the number of records in the internal database and XEVMPD Compare all products in the commercial sales database with XEVMPD Define the applicable Article 57 population as of a reference date and determine whether that population is appropriately represented in XEVMPD Review only products that have generated individual case safety reports

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XEVMPD Data Quality, Reconciliation and Detection of Hidden Errors

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