QPPV.COM KNOWLEDGE ASSESSMENT

Knowledge Assessment: Seriousness, Expectedness and ICSR Case Assessment

Test your understanding of the concepts covered by GVP Module VI: Seriousness, Expectedness and ICSR Case Assessment.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which quality-system control most directly supports defensible expectedness assessments?

Allowing each processor to use whichever product information version is most familiar Maintaining controlled access to the applicable reference safety information and its versions Replacing medical review with automated coding in all cases Using the database frequency of reactions as the primary expectedness rule

Question 2 of 10 Which scenario most directly supports a seriousness classification based on hospitalisation?

The patient contacted a pharmacy for advice and remained at home The patient attended an emergency department but was not admitted The patient was admitted to hospital because of the reported event The patient experienced intense symptoms but received routine outpatient treatment

Question 3 of 10 Which source should generally be used to assess expectedness for an EU post-authorisation case?

The processor's personal clinical experience The frequency of the event in the company's safety database The applicable, controlled reference safety information for the product and reporting context The reporter's opinion about whether the reaction was familiar

Question 4 of 10 Why should coding not be used as a shortcut for determining seriousness?

Coded terms are unrelated to the clinical information in a report A term that sounds severe may not meet a seriousness criterion, while a less dramatic term may do so in context Coding is performed only after causality is established Seriousness can be determined solely from the preferred term

Question 5 of 10 From an inspection perspective, what should an organisation be able to demonstrate about seriousness and expectedness classifications?

Only that the relevant database fields have been completed That every classification was made by the same individual That classifications were systematic, based on appropriate information and supported by documented processes and reasoning where needed That all borderline cases were automatically classified as serious and unexpected

Question 6 of 10 A product information document was updated to include a reaction after a historical case had been assessed. What should determine the historical expectedness assessment?

The most recent product information, applied retrospectively in all circumstances The reference information applicable to the relevant historical reporting context The reaction's current frequency in the safety database The date on which the case was entered into the safety database, regardless of context

Question 7 of 10 A report describes a potentially life-threatening event but does not yet contain all minimum information required for a valid ICSR. What is the most appropriate approach?

Classify the report as valid because the event is potentially life-threatening Use seriousness to compensate for the missing validity criteria Seek the missing minimum information and assess seriousness once the report is valid Reject the report permanently because the initial information is incomplete

Question 8 of 10 A reaction is absent from the applicable reference information, but the available evidence is insufficient to determine whether the product caused it. What is the correct interpretation?

Unexpected and causally related Expected because causality is uncertain Unexpected, with causality assessed separately as uncertain or otherwise appropriate Invalid because an unexpected reaction cannot be assessed

Question 9 of 10 Which type of evidence is most relevant to a causality assessment rather than an expectedness assessment?

Whether the reaction appears in the applicable reference information The version of the reference safety information used Temporal relationship, dechallenge, rechallenge and alternative causes Whether the reaction is commonly reported in the database

Question 10 of 10 A report initially describes dizziness. Follow-up confirms that the patient was admitted to hospital because of the dizziness. What should the organisation do?

Leave the original seriousness classification unchanged because dizziness is usually mild Reassess seriousness using the documented hospital admission Classify the event as unexpected without checking the reference information Replace the reported reaction with hospitalisation as the only clinical event

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Knowledge Assessment: Seriousness, Expectedness and ICSR Case Assessment

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