The term ‘severe’ must not be confused with ‘serious’. In the English language, ‘severe’ is used to describe the intensity (severity) of a specific event

A SUSAR is a serious ADR whose nature or severity is unexpected based on the applicable product information.

Unintended effect occurring at normal dose related to the pharmacological properties.

Reporting of AE cases by health professionals and pharmaceutical companies which does not derive from a study or any organized data collection scheme (i.e. is

Reports derived from organized data collection systems, including: Clinical trials Clinical registries Post-approval patient use programs Patient support programs Patient disease management programs Surveys of

Evaluation of the data supporting a detected signal to verify that there is sufficient evidence demonstrating a new potentially causal association, or a new aspect

A set of activities performed to determine whether there are signals associated with medicinal product (based on ICSRs, data from active surveillance systems or studies,

Reported information on a new possible causal relationship (or a new aspect of a known relationship) between an adverse event and a drug. A signal

This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risks Important potential

An important identified risk, important potential risk or important missing information. Medicinal product safety concerns are identified, characterized, and monitored in the DSUR, RMP and

Evidence of an absence of harm (not absence of evidence of harm). Judgement about safety takes into account the degree to which a given risk is acceptable.

results in death requires patient hospitalization results in persistent or significant disability or incapacity is life-threatening or is a congenital anomaly/birth defect. “Severe” describes the

A unique number assigned to each participant who enrolls into a clinical trial.

“1. An individual (either a healthy volunteer or a patient volunteer) whose reactions or responses to certain interventions are evaluated during a clinical trial. May

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to

Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and

A study in which one party, either the investigator or participant, is unaware of what medication or intervention the participant is taking; also called single-masked

A process of active evaluation of potential participants for enrollment in a trial. After a patient is recruited, screening occurs during the enrollment period to

The SAS Version 5 (V5) transport file format is an open standard developed by SAS to support data transfers between systems, especially those running different

SAS (previously “Statistical Analysis System”) is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation,[2]

Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT) is the most precise, comprehensive, standardized, multilingual clinical health terminology product in the world, owned and distributed

[FDA] A request to FDA to approve a change to an approved license application. See definitions for individual types of supplements. Source: SOPP 8401.2: Administrative

The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms,

A Task Force of Industry, NCAs, EMA, and SMEs who advise and provide recommendations on planning, development, implementation, and maintenance of IDMP standards in the

A single set of information and/or documents supplied by the applicant as a part of, or the complete, Application

Subject profiles are displays of study data of various modalities collected for an individual subject and organized by time. Source: Study Data Specifications (FDA)

The Study Tagging File (STF) is an xml file that should be provided with the eCTD submission of any file, or group of files belonging

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing;

The electronic format by which content of labeling should be submitted to the FDA. SPL utilizes Extensible Markup Language (XML). Source: FDA

SAS is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation, and predictive analytics. SAS

SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format.

ICH: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. According to US 21 CFR

The unque four digit number associated with an eCTD sequence, normally beginning with 0000 for the first sequence in an application.

A single set of information and / or electronic documents submitted at one particular time by the applicant as a part of, or the complete

Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from