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 What is the appropriate response when different reactions in the same case have different relationships to the reference safety information?

Assign the expectedness of the most serious reaction to every reaction Assess each relevant reaction against the applicable reference information Classify all reactions as unexpected if any one reaction is unexpected Use the overall case outcome instead of assessing reaction-level expectedness

Question 2 of 10 A reaction is clearly listed in the applicable reference information but results in substantial medical intervention. What follows from the reaction being expected?

No further seriousness assessment is needed Causality is established because the reaction is listed The reaction still requires assessment of seriousness, outcome, causality and other relevant elements The case is automatically non-serious

Question 3 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 4 of 10 What is the best interpretation of the medically important seriousness criterion?

It is simply another term for a severe reaction It applies only to events that resulted in hospital admission It may apply to an event that requires intervention to prevent a recognised serious outcome, subject to the applicable framework It applies automatically to every emergency-room visit

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 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 7 of 10 A patient reports extremely painful headache lasting several hours, with no hospitalisation, disability, life-threatening condition or other qualifying criterion. How should the event generally be classified?

Serious because the pain intensity is extreme Unexpected because severe symptoms are unusual Non-serious, while the clinical severity is recorded separately Causally related because the symptom is clinically severe

Question 8 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 9 of 10 A reaction is listed in the applicable reference information, but the clinical evidence provides little support for a relationship with the product. How should it be assessed?

Expected and necessarily causally related Unexpected because causality is uncertain Expectedness and causality should be assessed independently Non-serious because listed reactions are generally less important

Question 10 of 10 A pregnancy exposure report contains no adverse fetal or maternal outcome. How should it generally be handled with respect to congenital anomaly or birth defect?

Automatically classify it as a congenital anomaly because pregnancy was involved Classify it as a birth defect because fetal exposure is presumed Do not automatically apply the congenital anomaly criterion; assess the actual reported outcome Classify it as serious only when the exposure was intentional

Knowledge Assessment: Seriousness, Expectedness and ICSR Case Assessment

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