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…
Ennov to Sponsor the EUTMF Summit
Ennov will exhibit at the European Trial Master File Summit being held at the Roosevelt Hotel in London, UK on November 14-16, 2022. The EUTMF summit provides strategies, tools, and…
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…
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this blog post, we’ll summarize some…
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…
Recruitment
Active efforts by investigators to identify subjects who may be suitable for enrollment into a clinical trial. Subjects are selected on the basis of the protocol’s inclusion and exclusion criteria…
Real World Studies
Real-world studies seek to provide a line of complementary evidence to that provided by randomized controlled trials (RCTs). While RCTs provide evidence of efficacy, real-world studies produce evidence of therapeutic…
Randomized Allocation
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance. Source: Clinicaltrials.gov
Randomization
The process of assigning trial subjects to investigational treatment or control groups (may use a comparator) using an element of chance to determine the assignments in order to reduce bias.…
Query
A question raised about a data point in a CRF, which may or may not result in a correction. Note: this may also refer to an issue identified during document…
Protocol Deviation
Any change, divergence, or departure from the study design or procedures defined in the protocol Source: ICH
Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol. Source: ICH E6
Protocol
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information. Source: Clinicaltrials.gov
Principal Investigator
The person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical site. In most cases the principal investigator will be a leading…
Placebo
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied. Source: Clinicaltrials.gov
Pivotal Clinical Trial
A clinical study designed & executed to get statistically significant evidence of efficacy and safety in order to obtain its marketing approval by regulatory authorities. A pivotal study will generally…
Phase 4
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed…
Phase 3
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug…
Phase 2
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For…
Phase 1
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the…
Phase 0 (aka Early Phase 1)
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human…
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the…
Pharmacokinetics
The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. Source: NLM
Patient Registry
A type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world. Source: Clinicaltrials.gov
Orphan Drug
A drug used to treat, prevent, or diagnose an orphan disease. An orphan disease is a rare disease or condition that affects fewer than 200,000 people in the United States.…
Open Label Study
A type of study in which both the health providers and the patients are aware of the drug or treatment being given. Source: NCI
Observational Study
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other…
NCT Number
ClinicalTrials.gov identifier - The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Source: Clinicaltrials.gov
Multicenter Trial
A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out bymore than one investigator. Source: FDA Glossary
Monitoring Visit Report
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. Source: ICH E6
Monitoring Visit
An oversight visit to a clinical trial site to review the progress of the study and ensure protocol adherence, accuracy of data, safety of subjects and compliance with regulatory requirements…
Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP,…
Lost to Follow Up
The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. Source: FDA Glossary
Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator. Source: Clinicaltrials.gov
Investigational Site
A site at which clinical research is conducted, usually associated with a hospital or university.
Investigational New Drug Application (IND)
A request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must…
Investigational Drug
The drug being evaluated in the trial; this definition is synonymous with “investigational new drug” or “investigational medicinal product.”
Interventional Study (Clinical Trial)
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the…
Interim Analysis
Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial. Source: ICH E9
Institutional Review Board (IRB)
An IRB (also known as an independent ethics committee (IEC), ethical review board (ERB) or research ethics board (REB)) is a group of doctors, scientists, advocates, researchers, and members of…
Inspector
Representative of a Health Authority performing a GCP/TMF inspection.
Inspection
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the…
Informed consent form (ICF)
The document used in the informed consent or process. [Note that there is a "model informed consent" master document and an executed informed consent that is actually filled out and…
Informed Consent
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are…
Independent Ethics Committee
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of…
Inclusion Criteria
A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study. Source: Clinicaltrials.gov
Important Protocol Deviation
A subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may significantly affect a subject's rights, safety, or well-being.
Health Authority (HA)
A national or international health agency that has authority over and regulates a clinical study
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and…
Exclusion Criteria
A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. Source: Clinicaltrials.gov
Enrollment
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study. Source: Clinicaltrials.gov
Endpoint
Principal indicator(s) used for assessing the primary question (i.e., hypothesis) of a clinical trial. A variable that pertains to the efficacy or safety evaluations of a trial. An endpoint is…
Patient-Reported Outcome (PRO)
An outcome based on a report that comes directly from the patient about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a…
Electronic Patient Reported Outcome (ePRO)
See Patient-Reported Outcome (PRO) - ePRO collects this information electronically with an app, wearable, web page, etc.
Electronic Data Capture (EDC)
System capturing subject Case Report Form information.
Dropout
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol. (also Discontinuation) Source:…
Double-Blind Research Design
A study in which neither the participant nor the researcher knows whether the participant is in the treatment or control groups. Source: FDA Patient Glossary
Dose-Ranging Study
A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least…
Dose
The amount of medicine taken, or radiation given, at one time. Source: NCI
Data Monitoring Committee (DMC)
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be stopped if it…