Case Processing & Data Entry

Other drugs taken before or during the event; needed for interaction assessment and causality.

Identification of the specific batch or lot of the product; required for quality complaints and useful for signal clustering.

Result of the AE (recovered, recovering, sequelae, fatal, unknown); required for ICSR and aggregate analysis.

Point at which case data is fixed for reporting or analysis; changes after lock require versioning and justification.

Use of drug in excess of recommended dose; reportable as AE and may have specific management in SmPC.

Use outside approved indication, dose, or population; AEs from off-label use are still reportable.

Five-level structure: LLT → PT → HLT → HLGT → SOC. Coding at PT level; analysis often at SOC or PT.

Standard dictionary for coding drugs in ICSRs (e.g., WHO-DD, WHODrug Global). Supports E2B and signal analysis.

Dose, route, frequency, and duration; required for suspect drug in ICSR.

Reason for use of the drug (disease or condition); coded in MedDRA and reported in ICSR.

How the drug was given (oral, IV, etc.); E2B element and may affect causality or signal.

Primary case in a duplicate set; linked cases point to parent.

Case linked to another (e.g., duplicate, follow-up); relationship documented in database.

Process of closing a case when no further action (e.g., follow-up) is planned; should be documented.

Case awaiting follow-up information; tracked and pursued per SOP.

Change from non-serious to serious (or vice versa) based on new information; may create new Day 0.

Original words used to describe the AE (before coding); retained in database.

Most specific level in MedDRA hierarchy; maps to PT.

MedDRA level between PT and HLGT.

Highest level of MedDRA (e.g., Cardiac disorders, Hepatobiliary).

Single primary SOC assigned to PT for case (MedDRA allows one primary).

Some PTs may appear in more than one SOC; primary vs secondary.

Unique ID for the case in MAH database; used in submissions and linking.

Identifier for the report (initial or follow-up) within a case.

A post-mortem examination that may provide definitive information about cause of death in fatal adverse event cases.

A unique identifier assigned to a specific production batch of a drug product, essential for quality investigations and potential recalls.

A concise, clinically coherent written summary of an adverse event case that synthesizes all relevant information into a readable format for medical review.

Any medication taken by the patient alongside the suspected drug during the adverse event period, which may contribute to, confound, or interact with the event.

The point at which case data is frozen for regulatory submission or periodic report preparation, after which changes require formal amendments.

The discontinuation or dose reduction of a suspected drug following an adverse event, with observation of whether the reaction improves or resolves.

A standardized reference database (such as WHODrug) used to consistently code and classify drug names, substances, and formulations across adverse event reports.

The ICH standardized electronic format for transmitting Individual Case Safety Reports between pharmaceutical companies, regulatory authorities, and other stakeholders.

A structured report documenting a single patient's adverse event experience with a medicinal product, formatted according to ICH E2B standards for regulatory submission.

The most granular level in the MedDRA hierarchy, representing verbatim terms, synonyms, and lexical variants that link to a single Preferred Term.

A standardized international medical terminology used to classify and code adverse events, medical history, and indications in regulatory submissions and safety databases.

The patient's relevant pre-existing conditions, prior medications, allergies, and risk factors that may influence adverse event assessment and causality.

The patient's status at the time of the last observation: recovered/resolved, recovering/resolving, not recovered/not resolved, recovered with sequelae, fatal, or unknown.

A MedDRA term representing a single medical concept used for analysis, reporting, and signal detection. It is the primary level for regulatory safety analysis.

A report concerning the quality, integrity, or physical characteristics of a drug product, which may or may not be associated with an adverse event.

The readministration of a suspected drug to a patient after an adverse event, with observation of whether the reaction recurs. Positive rechallenge strongly supports causality.

The highest level in the MedDRA hierarchy, grouping Preferred Terms by body system, etiology, or purpose (e.g., Cardiac disorders, Infections and infestations).

A medicinal product that is suspected of causing or contributing to the reported adverse event, as determined by the reporter or safety assessor.

The duration between the start of drug exposure and the first occurrence of an adverse event, a critical factor in assessing plausibility of causal relationship.

The exact words used by the reporter to describe an adverse event, medical history, or other clinical information, preserved exactly as reported.