Similar reports are not yet a signal
Several reports arrive through different countries and channels using different verbatim descriptions. They may represent duplicates, background disease, a known adverse reaction, a product-quality issue, a reporting artifact, or new safety information.
The system must make related evidence visible without claiming that a count alone proves causality or a signal.
Intake preserves the source and first awareness
Channel, sender, receiver, organization, country, language, date received, date first known, source document, verbatim narrative, attachments, products, events, reporter and patient information, consent and privacy restrictions, linked complaint, and handoff remain intact.
Transcription and translation never replace the original. The record shows when the organization first had enough information to begin evaluation.
Minimum criteria and triage are explicit
Identifiable patient, identifiable reporter, suspect product, and adverse event or reaction criteria are assessed according to the applicable process. Valid, potential, invalid, noncase, product complaint, medical information, special situation, and follow-up-needed outcomes retain rationale.
Seriousness, special-interest status, pregnancy, medication error, overdose, abuse, misuse, occupational exposure, lack of effect, counterfeit concern, and quality defect can drive priority and routing.
Duplicate management protects case counts
Reporter, patient characteristics, country, dates, products, events, study, source, healthcare organization, narrative similarity, and external identifiers create candidate matches.
Merge, link, retain separate, split, nullify, or supersede decisions preserve source reports, case versions, submitted identifiers, follow-ups, and reviewer rationale.
Follow-up is question and source specific
Missing minimum or medically important information, reporter type, consent, contact route, questionnaire, attempts, dates, responses, translations, documents, medical records, product samples, and unsuccessful steps remain traceable.
New information creates a case version and may change seriousness, expectedness, causality, reportability, due date, coding, or prior submissions.
Coding retains verbatim and dictionary version
Reported event and indication terms, MedDRA lowest-level and preferred terms, hierarchy, dictionary version, coding rationale, recoding, medical review, product dictionary, substance, dose form, route, indication, lot, and concomitant therapy remain connected.
Version upgrades are assessed; historical submissions retain the terms and dictionary version actually used.
Medical assessment separates different judgments
Seriousness criterion, outcome, expectedness or listedness against the applicable reference, reporter causality, company causality, temporal relationship, dechallenge, rechallenge, alternatives, medical history, concomitants, mechanism, special-interest criteria, and reviewer conclusion remain separate fields with evidence.
An algorithm may support consistency but never replaces medical judgment.
Reportability is jurisdiction and context specific
Clinical or postmarketing status, application or authorization, authority, country, source type, seriousness, expectedness, causality, literature or study context, clock-start rule, reporting party, format, initial and follow-up timing, waiver, local affiliate, partner agreement, and rule version define the decision.
The system calculates from configured requirements and exposes the rationale; it does not hard-code one global seven- or fifteen-day rule.
ICSR messages have a lifecycle
Case and safety-report identifiers, version, message type, sender, receiver, E2B data elements, attachments, nullification or amendment, validation profile, errors, warnings, generated XML, transmission, acknowledgement, rejection, correction, resubmission, and archive form the submission record.
The accepted acknowledgement closes the technical loop; it does not replace case medical review or follow-up.
Case quality is measurable
Completeness, coding, chronology, source consistency, narrative, medical assessment, expectedness reference, reportability, due-date logic, privacy, attachments, duplicate assessment, data validation, peer review, correction, and approval form case QC.
Sampling plans and error trends can target training or process improvement without obscuring individual corrections.
Aggregate reports retain population and data cut
Report type, product and authorization scope, reporting interval, data-lock point, case inclusion rules, exposure source, searches, line listings, tabulations, signals, studies, actions, previous commitments, sections, authors, reviews, conclusions, submission, and acknowledgement form the aggregate-report record.
Tables and listings are reproducible queries against a frozen population. Safety scientists remain accountable for medical analysis, limitations, benefit-risk interpretation, conclusions, and proposed action.
Signal management begins after detection
Data source, search strategy, query or algorithm, MedDRA scope, product exposure, background, threshold, case series, literature, class effects, quality data, confounding, validation, priority, assessment, decision, action, owner, milestones, communication, and closure define the signal.
Potential, validated, refuted, ongoing, closed and re-opened states retain the evidence and governance decision.
Benefit-risk actions reach the product lifecycle
New study, enhanced surveillance, labeling, investigator brochure, informed consent, risk-management plan, risk-minimization measure, healthcare communication, regulatory consultation, product-quality action, field action, restriction, suspension, or no change can emerge from safety assessment.
Implementation and effectiveness remain linked to the signal and affected markets.
Safety agreements preserve who does what
Partner, product and territory scope, day-zero exchange, case and follow-up transfer, reconciliation, literature, submissions, signals, aggregate reports, contact coverage, formats, timelines, oversight, breach, change, and termination define the pharmacovigilance agreement.
Exchange records and reconciliation show whether both parties hold the intended cases and versions.
Pharmacovigilance composes clinical, quality, and regulatory evidence
EDC and CTMS supply clinical events and operational context; complaints and deviations supply product-quality evidence; RIMS supplies products, markets and commitments; document control retains approved references and reports.
Pharmacovigilance owns the safety case, medical and reportability decisions, ICSR lifecycle, aggregate safety analysis, signal governance, and benefit-risk action.