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GVP Module VIII: PASS Protocols, Objectives and Study Design

Test your understanding of the concepts covered by GVP Module VIII: PASS Protocols, Objectives and Study Design.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A non-interventional PASS uses propensity scores, time-to-event methods and extensive outcome validation. What does this illustrate?

The study has become interventional because advanced methods are being used Non-interventional status describes treatment assignment, not methodological simplicity Advanced statistical methods are inappropriate in pharmacovigilance Only randomized studies can address confounding

Question 2 of 10 Which statement correctly distinguishes a registry from a PASS?

A registry is always an imposed PASS A PASS is a safety study, whereas a registry is a data-collection structure that may serve as its data source A registry and a PASS are interchangeable terms A PASS cannot use an existing registry

Question 3 of 10 A protocol estimates the frequency of an outcome among exposed patients but makes a causal claim that the product caused each event. What is the main concern?

Frequency estimates are not permitted in PASS The interpretation exceeds what a descriptive design and objective may support Causal claims are always valid when the sample is large The study should replace the outcome with a surrogate endpoint

Question 4 of 10 What is the appropriate relationship between a PASS protocol and an RMP?

The PASS may investigate any topic as long as the database can support it The protocol should be consistent with the RMP safety concern and pharmacovigilance objective, with any disconnect explained The RMP replaces the need for a scientific research question The protocol should avoid referring to the RMP to preserve scientific independence

Question 5 of 10 What should a PASS sample-size or precision assessment primarily reflect?

A generic target number used in all observational studies The actual design, expected events and assumptions underlying the desired precision or detectable effect Only the number of participating countries The number of secondary endpoints proposed

Question 6 of 10 Which is the best example of a meaningful sensitivity analysis?

Running additional analyses until one produces the preferred conclusion Testing how the principal estimate changes under a clinically plausible alternative outcome definition Adding unplanned variables solely because they are available Repeating the primary analysis with identical assumptions and data

Question 7 of 10 Which control most directly supports reproducibility of the principal PASS analysis?

Allowing analysts to overwrite the original dataset when corrections are made Maintaining dataset versioning, extraction dates, controlled derivations and version-controlled analysis scripts Deleting intermediate datasets after the final report Relying on the memory of the lead analyst

Question 8 of 10 A study evaluating risk-minimisation measures reports that educational materials were distributed. What additional distinction is needed to determine effectiveness?

Distribution alone must be treated as proof that clinical risk decreased Implementation, reach, understanding, behaviour change and change in targeted clinical risk are separate endpoints Only the number of materials printed is relevant Effectiveness can be inferred from product sales

Question 9 of 10 Which statement best describes the role of the Statistical Analysis Plan in relation to the protocol?

The Statistical Analysis Plan may freely redefine the research question after protocol approval The protocol establishes the principal analytical approach, while the Statistical Analysis Plan may provide additional operational detail consistent with it The Statistical Analysis Plan eliminates the need to specify a primary analysis in the protocol The Statistical Analysis Plan is unrelated to protocol amendments

Question 10 of 10 Why should a PASS protocol clearly distinguish the primary objective from secondary objectives?

To ensure that all secondary analyses are statistically significant To identify the principal question driving the study and separate it from additional analyses To prevent any subgroup analysis from being conducted To allow the primary objective to be changed without regulatory review

GVP Module VIII: PASS Protocols, Objectives and Study Design

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