QPPV.COM KNOWLEDGE ASSESSMENT

Adverse Events from Social Media, Apps and Digital Platforms

Test your understanding of the concepts covered by Adverse Events from Social Media, Apps and Digital Platforms.

Question 1 of 10Pass mark: 80%

Question 1 of 10 An organisation is selecting a monitoring frequency for an MAH-controlled patient-support app. Which approach best reflects the article?

Use one universal interval for every digital channel because E2D(R1) specifies a fixed frequency. Choose a risk- and channel-based frequency that permits identification and reporting within applicable timelines. Review the app only when a user contacts the medical information department. Set the frequency according to staff convenience, provided monthly reconciliation is performed.

Question 2 of 10 A company page allows public comments and private messages, but its monitoring procedure covers only public comments. What is the main deficiency?

Private messages are outside pharmacovigilance because they are not publicly visible. The monitoring scope does not reflect the platform's actual functions through which safety information can arrive. The company must stop allowing all private messages. Only messages mentioning the full product name need to be monitored.

Question 3 of 10 A user reposts another person's story about an adverse reaction without adding any personal experience. What should the case processor consider before creating a new case?

Every repost is necessarily a separate report because it has a new author. Whether the content is original experience or copied material; a repost alone should not automatically be treated as a new independent case. A repost is always a product complaint rather than an adverse-event report. The reposting account automatically becomes the patient.

Question 4 of 10 A machine-translation service translates a valid digital report several hours after it was received. What is the most appropriate interpretation of translation's effect on timing?

Translation creates a new Day Zero because the case was not understandable before translation. Translation does not itself create a new Day Zero if the report was already valid before translation. The case becomes solicited because machine translation was used. The original-language source should be discarded once a translation exists.

Question 5 of 10 A safety message appears on an MAH's official page, after which the number of patient comments describing events rises sharply. What is the most appropriate interpretation of the increase?

It necessarily proves that the underlying incidence of the events has increased. It may reflect stimulated reporting and should not be equated automatically with epidemiological frequency. The comments should be excluded because they followed a safety communication. The increase converts all resulting reports into ODCS cases.

Question 6 of 10 A chatbot receives a message describing an accidental double dose and dizziness at 01:00. Human staff review flagged conversations from 08:00. What is the most important control implication?

Day Zero can always be set to the start of the next business day. The organisation should design detection and escalation so the regulatory clock is not treated as starting only when a human reads the message. The message is not a safety source because it was received by software. The report should be classified as solicited solely because the chatbot asked a follow-up question.

Question 7 of 10 A user says, “I ended up in the ER after taking this medicine,” but does not use the word “serious.” What is the most appropriate assessment?

The report cannot be serious because the user did not use regulatory terminology. The statement should be medically assessed against applicable seriousness criteria; the user's wording may describe a relevant criterion. Any mention of emergency care automatically establishes every seriousness criterion. Seriousness should be determined solely by the social-media moderator.

Question 8 of 10 An MAH plans a defined review of selected public forums over a specified period to analyse treatment tolerability. What is the most appropriate initial classification of this activity?

Routine screening of an MAH-controlled platform. An organised data collection system, if the planned review is consistent with organised data collection. Incidental awareness, because the forums are publicly accessible. An individual spontaneous report, regardless of how the review is designed.

Question 9 of 10 A patient independently posts an adverse reaction on an MAH-controlled product page. The page does not ask users to provide health information through a structured programme. How should the report generally be classified if it meets reporting criteria?

Solicited, because the MAH controls the page. Solicited, because all online reports are generated through data collection. Spontaneous, because the patient provided the information independently rather than through an organised collection activity. Not reportable, because comments on company pages are not valid sources.

Question 10 of 10 An MAH funds a patient organisation that runs an independent forum. The MAH has no control over the forum's content or communications. Which conclusion best follows from the article's platform-responsibility framework?

The forum is automatically under MAH responsibility because the MAH provides funding. The forum is not necessarily under MAH responsibility; control and operation matter, not funding alone. The forum is under MAH responsibility only if it contains a post about the MAH's product. The forum is an ODCS whenever the MAH has any financial relationship with its operator.

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Adverse Events from Social Media, Apps and Digital Platforms

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