Developmental International Birth Date (DIBD)
Date of approval of the first authorization for conducting an interventional clinical trial in any country. Determines the start of regulatory requirement. The first data lock point for the DSUR…
Important Risk
Definition according to GVP Annex I (Rev 3): An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for…
Potential Risk
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this…
Identified Risk
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest. Explanatory wording provided in GVP…
Temporal Relationship
Temporal relationship is considered positive if the event occurred during the use of the drug and/or within a plausible range based on the half-life of the drug. Categories for temporal…
Seriousness vs. Severity
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 (mild, moderate or severe); the…
Abuse
Persistent or sporadic, intentional excessive use of medicinal product, which is accompanied by harmful physical or psychological effects.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
A SUSAR is a serious ADR whose nature or severity is unexpected based on the applicable product information.
Unexpected Adverse Reaction
An adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information. Any event that is not expected, in accordance with the label (USPI…
Side Effect
Unintended effect occurring at normal dose related to the pharmacological properties.
WHO DD (WHO Drug Dictionary)
An international classification of drugs providing the names and active ingredient of medicinal products used in different countries.
WHOART (WHO Adverse Reactions Terminology)
Dictionary meant for rational coding of adverse reaction terms, maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring.
United States Prescribing Information (USPI)
It sets out the agreed usage of the drug in the USA and provides information for healthcare professionals on the drug’s usage, efficiency and safety. This is part if the…
Unexpected Adverse Drug Reaction
An adverse reaction whose nature, severity, specificity, or outcome is not consistent with the description given in product labelling or market authorization (USPI in the US, SmPC in Europe).
Type (A to F) of Adverse Drug Reaction
A (augmented): common dose-related reaction, related to a pharmacological action of the drug, predictable and with low mortality.B (bizarre): uncommon non-dose-related reaction, not related to a pharmacological action of the…
Spontaneous Reporting
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 not solicited). Stimulated reporting Reporting…
Solicited Reports
Reports derived from organized data collection systems, including: Clinical trialsClinical registriesPost-approval patient use programsPatient support programsPatient disease management programsSurveys of patients or healthcare providersInformation on efficacy or patient compliance
Signal Validation
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 of a known association.
Signal Management Process
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, literature information, etc.) including: Signal…
Signal
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 is considered important and warrants…
Safety Specification
This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risksImportant potential risksMissing information It should also address:…
Safety Concern
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 PSUR.
Safety
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.
International Serious Adverse Events Consortium (SAEC)
Non-profit consortium formed between the US FDA, industry, academia and the Wellcome Trust to identify genetic variants associated with SAEs.
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
results in deathrequires patient hospitalizationresults in persistent or significant disability or incapacityis life-threateningor is a congenital anomaly/birth defect.“Severe” describes the intensity of an event (mild, moderate or severe), the event…
Risk Minimization Activity
Product informationHealthcare professional communications / educational materialsPatient communications / educational materials
Risk Management Plan (RMP)
MAHs must prepare an RMP (Risk Management Plan) to implement the risk management system.
Risk Management
Activity that aims to ensure that the benefits of a medicinal product exceed the risks by the greatest achievable margin, by increasing the benefits or reducing the risks in three…
Risk
The probability of developing an outcome (refers normally but not always to a negative outcome). Absolute risk or Incidence Rate: The observed or calculated probability of the occurrence of an event in a…
Reference Risk (or Baseline Risk)
Risk in a population of unexposed persons. It can be measured over time (incidence) or at a given time (prevalence).
Rational Drug Use
Therapeutic practice where drugs are prescribed and used appropriately for the indication and the patient’s specific characteristics.
Prevalence
The proportion of total cases in a population at a particular time and a descriptive statistic, rather than a measurement of risk.
Prescription Event Monitoring (PEM)
System created to monitor adverse drug events for identified patients receiving a specified drug (prescribers are requested to report all events, suspected adverse or not).
Predisposing Factors
Aspects of the patient’s history which might explain reported adverse events (genetic, other drugs, disease history…).
Postmarketing Surveillance
The study of drug use and effects after release into the market.
Pharmacovigilance System
A system used by an organization to comply with pharmacovigilance regulations and designed to monitor the safety of authorized medicinal products.
Pharmacovigilance Master File
A compilation of information, maintained by the MAH. containing a detailed description of the pharmacovigilance system they use, available to competent authorities upon request.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, in order to: Prevent harm from ADRs in humans arising…
Pharmacoepidemiology
The study of the use and effects of drugs in large numbers of people using an epidemiological approach
Post-Authorization Safety Study (PASS)
Study relating to an authorized medicinal product conducted with the aim of studying a safety hazard, confirming the safety profile of the product, or evaluating risk management measures.
Overdose
Administration of a quantity of a medicinal product above the maximum recommended dose allowed by the authorized product information.
Off-Label Use or Misuse
Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the marketing authorization. For instance, medicine used: For disease that it is not approved…
Odds and Odds Ratio
An Odds is the probability of an occurrence divided by the probability of its non-occurrence. The Odds ratio is the ratio of the Odds between two populations.
Number Needed to Harm (NNH)
Number of individuals needed to be treated for some specified period in order that one person would have one harmful event.
Near-Misses
Medication errors with high potential for causing harm but did not (cancelled before reaching a patient or reaching the patient but who did not have untoward consequences).
National Pharmacovigilance Centers or National Competent Authority (NCA)
Regulatory authority within a country with the clinical and scientific expertise to collect, analyze and advise on drug safety.
Missing Information
Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance long term use). Typical examples…
Minimum Criteria for Reporting
An identifiable reporter, patient, event and a suspect medicinal product are required for reporting cases of suspected adverse events.
Medication Error
Any mistake in the way a medication is taken or administered (prescription, storage, dispensing, preparation, administration…), that has the potential to harm the patient. Medication errors are outside the use…
Unlabeled (or Labelled)
Any reaction not mentioned in the official approved product information is unlabeled (otherwise it is termed labelled).
Incidence
The rate of new cases of an outcome occurring per number of known at risk or exposed; and is a measurement of risk.
Important Medical Event (IME)
MedDRA includes a term list of important medical events (available on the EMA website), which aims to facilitate the classification of suspected ADRs, data analysis and the assessment of ICSRs.
ICH
International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals.
Harm
The nature and extent of actual damage that can be caused by a drug. Damage is measured by frequency of occurrence, severity or duration.
Good Pharmacovigilance Practice
The EMA has issued these guidelines for the conduct of pharmacovigilance in the EU for human medical products.
Frequency of ADRs
The following are standard ADR frequency categories where the denominator must be defined to provide context: Very common: > 10%Common: [1%, 10%]Uncommon: [0.1%, 1%]Rare: [0.01%, 0.1%]Very rare: <0.01%
Expedited Reporting
Rapid submission of an ICSR to the Regulatory Authorities in compliance with the legislation and local regulatory guidelines.
Expected Adverse Drug Reaction
ADR consistent with the reference safety information (Investigator’s brochure for an investigational product, summary of product characteristics) for an approved product.
EudraVigilance
The EMA’s system to support the electronic exchange, management, and evaluation of ICSRs related to all medicinal products authorized in the European Economic Area (EEA). Companies and Member States report…
EUDRAGENE
European collaboration that established a collection of DNA samples for studying genes which influence SARs or ADRs, for the purpose of a better understanding of adverse drug reactions.
Efficacy
The ability of a drug to produce the intended effect (scientific evaluation).
Drug Abuse
Intentional off-label use of a medicinal product. Although the drug is not being used according to the marketing authorization or physician’s recommendation, abuse can result in ADRs.
Designated Medical Event (DME)
Serious and rare medical event that is often causally associated with drugs across multiple pharmacological / therapeutic classes. Even small number of reports of such event can trigger a signal…
Disproportionality Analysis
Screening of ICSR databases for statistical associations between products and events whereby the observed frequency is different than the expected frequency. For ADRs caused by one drug (called drug-event pairs),…
Development pharmacovigilance and risk management plan
Plan to conduct the detection, assessment, understanding, reporting and prevention of AEs of medicinal products during clinical trials.
Development core safety information (DCSI)
This section of an Investigator’s Brochure (IB) is identical in structure to the CCSI and contains a summary of all relevant safety information (described in more detail in the rest…
Rechallenge
Rechallenge means reintroducing the drug to the patient. A positive rechallenge (the AE reappears) strongly suggests a causal relationship.
Dechallenge
Dechallenge is the withdrawal of a drug from a patient to observe: The continuity of an AE (negative dechallenge – causal relationship less likely)The reduction or disappearance of an AE…
Data Monitoring Committee
Synonyms: Independent Data Monitoring Committee, Data and Safety Monitoring Board This committee is established by the sponsor to: Assess the progress of a clinical trial, the safety data, and the…
Causal Relationship
The causal relationship between an AE and a suspected drug can be, according to the WHO: certain– sufficient information provided to determine that no other reasonable explanation exists, occurring in a plausible time…
Critical Terms
“Critical Terms” in WHOART refer to or might indicate serious disease states and warrant special attention.
Clinical Development Program
Refers to all clinical trials being conducted with the same investigational drug.
Council for International Organizations of Medical Sciences (CIOMS)
The CIOMS is a body set up under WHO and UNESCO. It has developed the following pharmacovigilance guidelines: I – International reporting form II – Periodic safety update reports (PSUR)…
Company Core Data Sheet (CCDS)
Document prepared by the MAH containing the medicinal product’s: Safety informationIndications, dosingPharmacology and other information concerning the product.
Company Core Safety Information (CCSI)
All safety information contained in the core data sheet prepared by the medicinal product MAH and which the MAH requires to be listed in all countries where the company markets…
Causality Assessment
Method for assigning probability to the likelihood of a causal relationship between an AE and a suspected drug; according to established algorithms.
Case Reports
Individual reports of the experience of single patients, or patients managed as group. At minimum, an adverse event case report must have a reporter, product, patient, and event. Individual Case…
Benefit-Risk Balance (Effectiveness/Risk)
An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks (quality, safety, or efficacy) of the medicinal product for the patients’ or public health.…
Benefit-Risk Assessments
Analysis of the favorable (beneficial) and unfavorable results of doing specific actions. Also called “benefit-harm” or “effectiveness-risk” analysis
Association
Events linked via one or multiple factors (i.e. chronology) but not necessarily having a cause and effect relationship.
Aggregate reports
Reports of a set of cases, meant for regulatory authorities. Annual Safety Report (ASR): In clinical trials, an annual report of all newly available safety information. An ASR includes a global…
Adverse Event of Special Interest (AESI)
A noteworthy event for a product or class of products that a sponsor wants to monitor carefully. It can be serious or non-serious, or it be potential precursor or prodrome…
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand the clinical risk in light…
Uncontrolled Study
A clinical study that lacks a comparison (i.e., a control) group. Source: NCI
TMF Reference Model
A de facto industry standard that provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.
Subject Number
A unique number assigned to each participant who enrolls into a clinical trial.
Subject
"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 also be referred to as…
Subinvestigator
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 make important trial-related decisions (e.g.,…
Study Coordinator
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 sponsor, and reviews all data…
Single-Blind Research Design
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 study. Source: FDA Patient Glossary
Screening
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 see if they meet the…
SAS Transport Files
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 operating systems. The SAS V5…
SAS
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] and predictive analytics. SAS files…