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ICH E2D(R1): What Changed in Post-Approval Pharmacovigilance

Test your understanding of the concepts covered by ICH E2D(R1): What Changed in Post-Approval Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 of 10 An organisation is designing its internal safety database taxonomy while some regional systems have not yet implemented new E2B(R3) source values. What is the best data-governance approach?

Use only the currently accepted regional transmission value as the internal classification. Maintain the E2D(R1) source and report-type classification internally, with a controlled mapping to currently accepted regional transmission values. Delay all E2D(R1) source classification until every region implements the new values. Replace source classification with a free-text narrative to avoid mapping differences.

Question 2 of 10 Which practice best reflects E2D(R1) expectations for an ICSR narrative?

Reproduce the order in which information fragments arrived, without integrating the clinical chronology. Present a stand-alone medical story in patient-experience chronology and distinguish source information from MAH interpretation. Replace the primary-source account with the MAH's preferred causal conclusion. Include only coded event terms because narrative information is not needed for medical review.

Question 3 of 10 A medicine-delivery service is combined with nurse calls that provide administration support and medical advice. How should the activity be assessed for safety-source classification?

Classify delivery and nurse calls separately in every case, even when they operate as one programme. Assess the combined programme; if it meets the PSP criteria, safety information from it is handled as solicited PSP information. Classify all reports as spontaneous because medicine delivery is not medical care. Classify the programme as an MRP because it includes patient interactions.

Question 4 of 10 An MAH plans a structured review of public online posts but is not conducting the activity under a formal protocol. Which documentation approach is most consistent with E2D(R1) and the EU implementation strategy?

No documentation is needed because the posts are publicly available. Document the activity's objective, data sources, dataset or review scope, review method, and safety-information management process. Document only the vendor's name and the date the activity ends. Create a clinical-study protocol, because every ODCS must be a formal study.

Question 5 of 10 A medication error is reported without an associated AE/ADR. Which statement best reflects the E2D(R1) framework?

It can never require PV action because no adverse event occurred. It is automatically an ICSR in every region. It may need to be recorded or followed up, while ICSR submission depends on regional requirements or specific regulatory conditions. It must be classified as a spontaneous adverse reaction.

Question 6 of 10 A solicited case arose from a patient support programme conducted through a digital platform. When the relevant new E2B(R3) values are implemented, which C.5.4 source value has priority under the described hierarchy?

The generic digital-platform ODCS value, because the programme used a digital platform. The patient support programme value, because it is the more specific source classification. The market research programme value, because all patient programmes are consumer research. The value for spontaneous reports, because patients supplied the information.

Question 7 of 10 An MAH conducts a non-interventional study using existing claims data collected originally for healthcare administration. Which ICSR approach is most consistent with E2D(R1)?

Automatically submit every coded adverse outcome as an individual case. Do not report outcomes identified through secondary use as ICSRs unless regional or local requirements specify otherwise. Treat every outcome as a solicited report because the analysis was planned. Submit only outcomes for which the database contains a named reporter.

Question 8 of 10 Before EudraVigilance implements the new PSP C.5.4 value, how should an EU MAH code a PSP case for transmission according to the article?

Use the new PSP value immediately, even if the regional system has not implemented it. Continue using the existing C.5.4 value '3 = Other studies' until the new value is implemented, while retaining the correct internal classification. Use the generic digital-platform value for every PSP case. Change the case to a spontaneous report to avoid an unsupported study value.

Question 9 of 10 A contracted programme operator receives a valid report on Monday and transfers it to the MAH's central PV team on Thursday. Which Day Zero principle should guide the assessment?

Day Zero is always Thursday because that is when central PV received the report. The operator's receipt may establish MAH awareness because it acts on the MAH's behalf; internal transfer delay does not automatically reset Day Zero. Day Zero begins only after the MAH confirms causality. Day Zero begins when the operator completes its weekly transfer batch.

Question 10 of 10 A case has been determined, under applicable regional rules, to require expedited reporting. What expedited submission timeframe does E2D(R1) describe?

No later than 15 calendar days after Day Zero. No later than 15 business days after database entry. No later than 30 calendar days after causality assessment. Only by the next periodic safety report.

ICH E2D(R1): What Changed in Post-Approval Pharmacovigilance

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