Case Intake & Triage

Report that the drug did not work as expected; not an AE per se but may be reportable in some regions or in trials.

Complaint about physical quality of product (e.g., packaging, contamination). If associated with AE, both are reported.

Error in prescribing, dispensing, or administration; may be reportable and should be captured when it leads to or is part of AE.

Report that after assessment does not meet criteria for valid case or reportable case.

Case that does not meet minimum criteria (e.g., missing one of four elements); not reportable as valid ICSR.

First report of a case; distinct from follow-up.

Date when MAH first became aware of the case (may be Day 0 for expedited reporting).

Date report was received by MAH; may differ from awareness date in some definitions.

Origin of report (e.g., spontaneous, study, literature, regulatory).

Report received from regulatory authority (e.g., from another country).

Report from a clinical trial or non-interventional study.

Case identified from published literature; processed as ICSR when valid.

MAH employee or contractor (e.g., medical rep) who may receive AE information; must forward to PV.

Designated contact (e.g., phone, email) for reporting AEs to MAH.

Initial assessment and routing of incoming report (validity, seriousness, urgency).

Report requiring immediate attention (e.g., fatal, life-threatening, recall).

Literature screening for local (e.g., non-English) publications as required.

The date when a company first becomes aware of a reportable adverse event through any of its employees, contractors, or partners acting on its behalf.

The initiation of the regulatory reporting timeline, triggered when minimum criteria for a reportable case are met. The clock determines the deadline for submitting expedited or periodic reports.

An adverse event report received from a patient, family member, or other non-healthcare professional individual who has direct experience with the product.

The date when a company first becomes aware of information that constitutes a valid, reportable adverse event case. This date starts the regulatory reporting clock.

The process of identifying whether a newly received adverse event report describes the same occurrence as a previously recorded case, to avoid counting the same event multiple times.

A subsequent submission that provides new, additional, or corrected information to a previously submitted ICSR.

A medically qualified person such as a physician, pharmacist, nurse, or dentist who reports or is involved in an adverse event case. HCP reports may be weighted differently in safety assessments.

A patient in an adverse event report who can be identified by at least one qualifier such as initials, date of birth, age, age group, gender, or patient identification number.

The person reporting the adverse event who can be identified by name, initials, address, qualification, or contact information sufficient for follow-up if needed.

The first submission of an Individual Case Safety Report (ICSR) to a regulatory authority, containing all available information at the time of submission.

An adverse event case identified through published medical or scientific literature that mentions the company's product in association with an adverse event.

An inquiry to the company's medical information department that may contain embedded adverse event information requiring capture and processing.

The four essential data elements required to consider an adverse event report valid and processable: identifiable reporter, identifiable patient, suspect product, and adverse event/reaction.

Classification of the person reporting an adverse event: healthcare professional (HCP), consumer/patient, lawyer, regulatory authority, or other. This affects follow-up strategy and some regulatory reporting.

An adverse event report obtained through organized data collection systems such as clinical trials, registries, patient support programs, or active surveillance programs.

Original records or certified copies containing raw data and observations about an adverse event, such as medical records, lab reports, emails, or call recordings.

An unsolicited adverse event report that comes from sources outside organized data collection systems, typically from healthcare professionals or patients who voluntarily report their experience.

The initial assessment process to prioritize incoming adverse event reports based on seriousness, expectedness, and regulatory reporting requirements.

An adverse event report that contains the four minimum required elements: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event or outcome.

A centralized system where all adverse event reports are collected, stored, and managed globally for a pharmaceutical company's products.