Phoenix Glossary of Real-World Evidence Terms

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    Definition
  • Adaptive Algorithm
    Adaptive Algorithm USA: FDA - An adaptive algorithm (e.g., a continuous learning algorithm) changes its behavior using a defined learning process. The algorithm adaptation or changes are implemented such that for a given set of inputs, the output may be different before and after the changes(...) Read More
  • Advanced Electronic Signature
    Advanced Electronic Signature UK: MHRA ‘GXP’ Data Integrity Guidance and Definitions - an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the(...) Read More
  • Adverse Event (AE)
    Adverse Event Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. In the context of pharmacovigilance and outside a clinical trial: any untoward medical(...) Read More
  • AI
    Artifical Intelligence (AI) USA: FDA - AI = Artificial Intelligence has been broadly defined as the science and engineering of making intelligent machines, especially intelligent computer programs (McCarthy, 2007). Artificial intelligence can use different techniques, including models based(...) Read More
  • Archive
    Archive UK: MHRA Guidance on GxP Data Integrity - A designated secure area or facility (e.g. cabinet, room, building or computerised system) for the long term, retention of data and metadata for the purposes of verification of the process or activity (as per Section 6.17.1 of MHRA – Guidance(...) Read More
  • Artificial Intelligence
    Artificial Intelligence USA: FDA - Artificial Intelligence has been broadly defined as the science and engineering of making intelligent machines, especially intelligent computer programs (McCarthy, 2007). Artificial intelligence can use different techniques, including models based on(...) Read More
  • Audit Trail
    Audit Trail UK: MHRA Guidance on GxP Data Integrity - The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation,(...) Read More
  • Backup
    Backup UK: MHRA Guidance on GxP Data Integrity - A copy of current (editable) data, metadata and system configuration settings maintained for recovery including disaster recovery (as per Section 6.17.2 of MHRA – Guidance on GxP data integrity, March 2018). Read More
  • Big Data
    Big Data “Big Data” refers to large, often aggregated real world data sets that are beyond the ability of commonly available stand-alone personal computers and software to handle. “Big data studies” are not those studies that are undertaken as primary data collection from or about individual(...) Read More
  • Causal Inference
    Causal Inference China: Key Considerations in Using Real-World Evidence to Support Drug Development - An inferential action, often based on real-world data, that characterizes the causal relationship between interventions or exposures to clinical or health outcomes, taking into account the(...) Read More
  • CER
    Comparative Effectiveness Research (CER) China: Key Considerations in Using Real-World Evidence to Support Drug Development - A research method, by considering both individuals and the population in an environment as close as possible to the real world, that evaluates the clinical(...) Read More
  • Clinical Investigation
    Clinical Investigation USA: 21 CFR 312 - Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the(...) Read More
  • Clinical Study
    Clinical Study EU: Clinical Trials Regulation - ‘Clinical study’ means any investigation in relation to humans intended: to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; to identify any adverse reactions to one or(...) Read More
  • Clinical Trial
    Clinical Trial ICH GCP - Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study(...) Read More
  • Comparative Effectiveness Research
    Comparative Effectiveness Research China: Key Considerations in Using Real-World Evidence to Support Drug Development - A research method, by considering both individuals and the population in an environment as close as possible to the real world, that evaluates the clinical effectiveness and(...) Read More
  • Data
    Data UK: MHRA Guidance on GxP Data Integrity - Data = Facts, figures and statistics collected together for reference or analysis. All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, thatare(...) Read More
  • Data Cleaning
    Data Cleaning UK: MHRA ‘GXP’ Data Integrity Guidance and Definitions - The process of detecting and correcting (or removing) corrupt or inaccurate records from a record set, table, or database and refers to identifying incomplete, incorrect, inaccurate or irrelevant parts of the data and then(...) Read More
  • Data Element
    Data Element A unit of data that has a precise meaning or semantic. As such the description of a data element should include a definition, a unit and, where relevant, the process by which the data element was generated (as per Section 8.6 of HMA/EMA Joint Task Force on Big Data - Interim(...) Read More
  • Data Integrity
    Data Integrity UK: MHRA Guidance on GxP Data integrity - Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained(...) Read More
  • Data Model
    Data Model An abstract representation which organises data fields in a relational manner to define the relationships between them and to identify how they relate to the characteristics of the real “objects”. When this representation becomes widely applied, shared and accepted by stakeholders,(...) Read More
  • Data Processing
    Data Processing UK: MHRA Guidance on GxP Data Integrity - A sequence of operations performed on data to extract, present or obtain information in a defined format. Examples might include: statistical analysis of individual patient data to present trends or conversion of a raw electronic(...) Read More
  • Data Quality
    Data Quality UK: MHRA ‘GXP’ Data Integrity Guidance and Definitions - The assurance that data produced is exactly what was intended to be produced and fit for its intended purpose. This incorporates ALCOA = Acronym referring to Attributable, Legible, Contemporaneous, Original and Accurate (as(...) Read More
  • Data Sharing
    Data Sharing Can be defined as the practice of making original health data available for secondary research purposes by other investigators; data may be shared in various formats and the process of data release can range from sharing under open access arrangements to sharing under controlled(...) Read More
  • Data Standard
    Data Standard USA: FDA’s Framework for Real-World Evidence Program - Glossary- a set of rules about how a particular type of data should be structured, defined, formatted, or exchanged between computer systems. Data standards make submissions predictable, consistent, and have a form that an(...) Read More
  • Data Utilisation Plan
    Data Utilisation Plan (DUP) Refers to a research plan, project plan or a similar plan that states the intended purpose of the data referred to in the permit application, the controller and processor of the data, the legal ground for the processing and the essential factors of the data(...) Read More
  • Digital Health
    Digital Health An overarching term that comprises eHealth (which includes mHealth), and emerging areas, such as the use of computing sciences in the fields of artificial intelligence, big data and genomics (Source - Glossary of WHO Guideline: Recommendations on Digital Interventions for(...) Read More
  • Directly Accessible
    Directly Accessible UK: MHRA ‘GXP’ Data Integrity Guidance and Definitions - At once; without delay (as per MHRA ‘GXP’ Data Integrity Guidance and Definitions - March 2018) Read More
  • Disease Registries
    Disease Registries EU: EMA Use of Patient Disease Registries for Regulatory Purposes - Disease registries are patient registries where entry is determined by the diagnosis of a disease (as per Section 3.2 of EMA – Discussion paper: Use of patient disease registries for regulatory purposes –(...) Read More
  • Drug Intensive Surveillance
    Drug Intensive Surveillance CHINA - Drug intensive surveillance refers to drug safety monitoring activities conducted in order to further understand the clinical use of drugs and occurrence of adverse reactions and study the characteristics, severity, and incidence rate, etc. of adverse(...) Read More
  • DUP
    Data Utilisation Plan (DUP) Refers to a research plan, project plan or a similar plan that states the intended purpose of the data referred to in the permit application, the controller and processor of the data, the legal ground for the processing and the essential factors of the data(...) Read More
  • Effectiveness Trials
    Effectiveness Trials EU: imi Get Real Glossary - Clinical studies investigating health interventions whose design does not follow the design of a randomised controlled clinical trial and aims to reflect health intervention effectiveness in routine clinical practice. Effectiveness studies do(...) Read More
  • eHealth
    eHealth The use of information and communications technology (ICT) in support of health and health-related fields, including health care services, health surveillance, health literature, and health education, knowledge and research. mHealth is a component of eHealth (Source - Glossary of WHO(...) Read More
  • Electronic Messaging Standard
    Electronic Messaging Standard An electronic messaging standarddefines an electronic format to exchange a set of data fields inan un-ambiguous and interoperable way between stakeholders. In simple words this represents a way to encode data elements (including sequencing and error handling) to(...) Read More
  • Electronic Signature
    Electronic Signature UK: MHRA Guidance on GxP Data Integrity - A signature in digital form (bio-metric or non-biometric) that represents the signatory. This should be equivalent in legal terms to the handwritten signature of the signatory (as per Section 6.14 of MHRA – Guidance on GxP data(...) Read More
  • eSignature
    eSignature = Electronic Signature UK: MHRA Guidance on GxP Data Integrity - A signature in digital form (bio-metric or non-biometric) that represents the signatory. This should be equivalent in legal terms to the handwritten signature of the signatory (as per Section 6.14 of MHRA – Guidance(...) Read More
  • eSource DDC
    eSource DDC The general term “eSource DDC” refers to an electronic application and/or device that allows direct entry of source data, and to directly identify some of these data as CRF (Case Report Form) data, for clinical trial purposes at the point of care by investigator site staff, for(...) Read More
  • External Control
    External Control China: Key Considerations in Using Real-World Evidence to Support Drug Development - The control in clinical trials established based on data outside the scope of the study, such as real-world data, to evaluate the effects of the interventions under investigation. External(...) Read More
  • GCP
    Good Clinical Practice (GCP) ICH GCP - GCP = Good Clinical Practice = 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 that the(...) Read More
  • Good Clinical Practice
    Good Clinical Practice ICH 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 that the rights, integrity, and(...) Read More
  • Good Pharmacovigilance Practices
    Good Pharmacovigilance Practices EU: GVP - Good pharmacovigilance practices (GVP) for the European Union (EU-GVP) = A set of guidelines for the conduct of pharmacovigilance in the European Union (EU), drawn up based on Article 108a(a) of Directive 2001/83/EC, by the European Medicines Agency(...) Read More
  • GVP
    Good Pharmacovigilance Practices (GVP) EU: GVP - Good pharmacovigilance practices (GVP) for the European Union (EU-GVP) = A set of guidelines for the conduct of pharmacovigilance in the European Union (EU), drawn up based on Article 108a(a) of Directive 2001/83/EC, by the European Medicines(...) Read More
  • GxP
    GxP UK: MHRA ‘GXP’ Data Integrity Guidance and Definitions - Good ‘X’ Practice where ‘X’ is used as a collective term for: GDP – Good Distribution Practice GCP – Good Clinical practice GLP – Good Laboratory Practice GMP – Good Manufacturing Practice GPvP – Good(...) Read More
  • IMP
    Investigational Medicinal Product (IMP) EU: Clinical Trials Directive - An investigational medicinal product (IMP) is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but(...) Read More
  • IND
    Investigational New Drug USA: 21 CFR 312 - Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms “investigational drug” and “investigational(...) Read More
  • Intervention
    Intervention USA: 45 CFR 46 - Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (as per 45 CFR 46.102(e)(2)) Read More
  • Interventional
    USA: 42 CFR 11 - Interventional means, with respect to a clinical study or a clinical investigation, that participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health-related(...) Read More
  • Interventional Clinical Trials
    Interventional Clinical Trials ICH E2F - An interventional clinical trial is any research study that prospectively assigns people to one or more health-related interventions (e.g., preventive care, drugs, surgical procedures, behavioural treatments, etc.) to evaluate their effects on(...) Read More
  • Interventional Studies
    Interventional Studies USA - clinicaltrials.gov - 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 interventions on biomedical or health-related(...) Read More
  • Investigational Medicinal Product
    Investigational Medicinal Product EU: Clinical Trials Directive - An investigational medicinal product (IMP) is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used(...) Read More
  • Investigational New Drug
    Investigational New Drug USA: 21 CFR 312 - Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms “investigational drug” and “investigational(...) Read More
  • Large Simple Trials
    Large Simple Trials EU: imi GetReal Glossary - Large simple trials are pragmatic, randomised clinical trials with minimal data collection protocols that are narrowly focused on clearly defined outcomes that are important to patients as well as clinicians. Their large sample size provides the(...) Read More
  • LICT
    Low-Intervention Clinical Trial (LICT) EU: Clinical Trials Regulation - LICT = Low-intervention clinical trial = Means a clinical trial which fulfils all of the following conditions: the investigational medicinal products, excluding placebos, are authorised; according to the protocol(...) Read More
  • Locked Algorithm
    Locked Algorithm USA: FDA - We define a “locked” algorithm as an algorithm that provides the same result each time the same input is applied to it and does not change with use. Examples of locked algorithms are static look-up tables, decision trees, and complex classifiers (Source: “Proposed(...) Read More
  • Low-Intervention Clinical Trials
    Low-Intervention Clinical Trials EU: Clinical Trials Regulation - ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions: the investigational medicinal products, excluding placebos, are authorised; according to the protocol of the(...) Read More
  • Low-Intervention Clinical Trial
    Low-Intervention Clinical Trial EU: Clinical Trials Regulation - ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions: the investigational medicinal products, excluding placebos, are authorised; according to the protocol of the(...) Read More
  • Machine Learning
    Machine Learning USA: FDA - Machine Learning is an artificial intelligence technique that can be used to design and train software algorithms to learn from and act on data. Software developers can use machine learning to create an algorithm that is ‘locked’ so that its function does not(...) Read More
  • Medical Claims Data
    Medical Claims Data China: Key Considerations in Using Real-World Evidence to Support Drug Development - A compilation of information on medical claims submitted to insurance companies for access to claims for treatments and other interventions (as per Key Considerations in Using Real-World(...) Read More
  • Metadata
    Metadata UK: MHRA Guidance on GxP Data Integrity - Metadata are data that describe the attributes of other data and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data e.g. audit trails.(...) Read More
  • mHealth
    mHealth The use of mobile and wireless technologies to support health objectives (Source - Glossary of WHO Guideline: Recommendations on Digital Interventions for Health System Strengthening, 2019) Read More
  • Missing Information
    Missing Information Gaps in knowledge about a medicinal product, related to safety or use in particular patient populations, which could be clinically significant (source: GVP - Annex 1: Definitions) Read More
  • ML
    Machine Learning (ML) USA: FDA - ML = Machine Learning is an artificial intelligence technique that can be used to design and train software algorithms to learn from and act on data. Software developers can use machine learning to create an algorithm that is ‘locked’ so that its function does(...) Read More
  • MMA
    Mobile Medical Application(s) or Mobile Medical App(s) = MMA USA: FDA - Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of(...) Read More
  • Mobile Medical Apps
    Mobile Medical Apps USA: FDA - Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software. Mobile medical apps(...) Read More
  • NIS
    Non-Interventional Study (NIS) EU: Clinical Trials Directive - NIS = Non-Interventional Study = A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic(...) Read More
  • Non-Interventional Study
    Non-Interventional Study EU: Clinical Trials Directive - A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by(...) Read More
  • Normal Clinical Practice
    Normal Clinical Practice EU: Clinical Trials Regulation - ‘Normal clinical practice’ means the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder (as per Article 2.2(6) of Regulation EU/536/2014) Read More
  • Observational Studies
    Observational Studies USA: FDA’s Framework for Real-World Evidence Program - A non-interventional clinical study design that is not considered a clinical trial (as per Framework for FDA’s Real-World Evidence Program - Glossary) USA: clinicaltrials.gov - A type of clinical study in which(...) Read More
  • Observational Study
    Observational Study USA: FDA’s Framework for Real-World Evidence Program - A non-interventional clinical study design that is not considered a clinical trial (as per Framework for FDA’s Real-World Evidence Program - Glossary) USA: clinicaltrials.gov - A type of clinical study in which(...) Read More
  • Original Record
    Original Record UK: MHRA Guidance on GxP Data Integrity - The first or source capture of data or information e.g. original paper record of manual observation or electronic raw data file from a computerised system, and all subsequent data required to fully reconstruct the conduct of the GXP(...) Read More
  • PAES
    Post-Authorisation Efficacy Study (PAES) EU: EMA Scientific Guidance on Post-Authorisation Efficacy Studies - Post authorisation efficacy studies (PAES) of medicinal products are studies subsequently conducted within the authorised therapeutic indication to address well-reasoned scientific(...) Read More
  • PASS
    Post-Authorisation Safety Study (PASS) EU: Directive 2001/83/EC - PASS = Post Authorisation Safety Study = Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal(...) Read More
  • Patient Registries
    Patient Registries Organized systems that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves one or more predetermined scientific, clinical, or(...) Read More
  • Patient Registry
    Patient Registry An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves one or more predetermined scientific, clinical, or(...) Read More
  • Patient Reported Outcome
    Patient Reported Outcome USA: FDA’s Framework for Real-World Evidence Program - A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of the patient’s health condition without amendment or interpretation of the patient’s response by a(...) Read More
  • PCT
    Pragmatic Clinical Trial (PCT) EU: imi GetReal Glossary - A study comparing health interventions among a randomised, diverse population representing clinical practice, and measuring a broad range of health outcomes. To ensure generalizability, pragmatic trials should represent the intended(...) Read More
  • Post Authorisation Efficacy Study
    Post Authorisation Efficacy Study EU: EMA Scientific Guidance on Post-Authorisation Efficacy Studies - Post authorisation efficacy studies (PAES) of medicinal products are studies subsequently conducted within the authorised therapeutic indication to address well-reasoned scientific(...) Read More
  • Post Authorisation safety Study
    Post Authorisation safety Study EU: Directive 2001/83/EC - Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of(...) Read More
  • Pragmatic Clinical Trial
    Pragmatic Clinical Trial EU: imi GetReal Glossary - A study comparing health interventions among a randomised, diverse population representing clinical practice, and measuring a broad range of health outcomes. To ensure generalizability, pragmatic trials should represent the intended patients(...) Read More
  • Pragmatic Clinical Trials
    Pragmatic Clinical Trials EU: imi GetReal Glossary - A study comparing health interventions among a randomised, diverse population representing clinical practice, and measuring a broad range of health outcomes. To ensure generalizability, pragmatic trials should represent the intended(...) Read More
  • PRO
    Patient Reported Outcome (PRO) USA: FDA’s Framework for Real-World Evidence Program - A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of the patient’s health condition without amendment or interpretation of the patient’s response by(...) Read More
  • Product Registries
    Product Registries EU: EMA Use of Patient Disease Registries for Regulatory Purposes - Product registries are patient registries where entry is determined by the prescription of a specific drug (as per Section 3.2 of EMA – Discussion paper: Use of patient disease registries for regulatory(...) Read More
  • Prospective Observational Study
    Prospective Observational Study USA: FDA’s Framework for Real-World Evidence Program - A study in which the population of interest is identified at the start of the study, and exposure/treatment and outcome data are collected from that point forward. The start of the study is defined as the(...) Read More
  • Randomized Controlled Trial
    Randomized Controlled Trial China: Key Considerations in Using Real-World Evidence to Support Drug Development - A clinical trial that utilizes a randomization method in subject assignment to experimental and appropriate control groups (as per Key Considerations in Using Real-World Evidence(...) Read More
  • Raw Data
    Raw Data UK: MHRA Guidance of GxP Data Integrity - Raw data is defined as the original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in(...) Read More
  • RCT
    Randomised Controlled Trial (RCT) China: Key Considerations in Using Real-World Evidence to Support Drug Development - A clinical trial that utilizes a randomization method in subject assignment to experimental and appropriate control groups (as per Key Considerations in Using Real-World(...) Read More
  • Real World Data
    Real World Data USA: FDA’s Framework for Real-World Evidence Program - Data relating to patient health status and/ or the delivery of health care routinely collected from a variety of sources (as per Framework for FDA’s Real-World Evidence Program - Glossary) China: Key Considerations in(...) Read More
  • Real World Evidence
    Real World Evidence USA: FDA’s Framework for Real-World Evidence Program- Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD (as per Framework for FDA’s Real-World Evidence Program - Glossary) EU: imi GetReal Glossary -(...) Read More
  • Real World Research
    Real World Research China: CDA - Real World Research (RWR) refers to the collection of patient-related data in a real-world environment (real-world data), and obtaining clinical evidence (real-world evidence) of the value and potential benefits or risks of the medical products through(...) Read More
  • Real World Study
    Real World Study EU: imi GetReal Glossary - Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT and aims to reflect health intervention effectiveness in routine clinical practice. Real world studies do not typically include(...) Read More
  • Registry
    Registry EU: GVP - An organised system that uses observational methods to collect uniform data on specified outcomes in a population defined by a particular disease, condition or exposure (Source: Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 4)) EU:(...) Read More
  • Registry Study
    Registry Study EU: EMA Use of Patient Disease Registries for Regulatory Purposes - The data collected in a registry may be used for the purpose of a specific study, i.e. a detailed investigation of a research question or hypothesis. The difference between a registry and a registry-based study(...) Read More
  • Retrospective Observational Study
    Retrospective Observational Study USA: FDA’s Framework for Real-World Evidence Program - A study that identifies the population and determines the exposure/treatment from historical data (i.e., data generated before the initiation of the study). The variables and outcomes of interest are(...) Read More
  • Risk Management Plan
    Risk Management Plan EU: Directive 2001/83/EC - A detailed description of the risk management system (as per Article 1(28c) of Directive 2001/83/EC). EU: Regulation EU/520/2012 - The risk management plan established by the marketing authorisation holder shall contain the following(...) Read More
  • Risk Management System
    Risk Management System EU: Directive 2001/83/EC - A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions (as per(...) Read More
  • Risk Minimisation Measure
    Risk Minimisation Measure EU: GVP Annex I - Risk minimisation measure; synonym: Risk minimisation activity = Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should(...) Read More
  • RMP
    Risk Management Plan EU: Directive 2001/83/EC - A detailed description of the risk management system (as per Article 1(28c) of Directive 2001/83/EC). EU: Regulation EU/520/2012 - The risk management plan established by the marketing authorisation holder shall contain the following(...) Read More
  • RWD
    Real World Data (RWD) USA: FDA’s Framework for Real-World Evidence Program - Data relating to patient health status and/ or the delivery of health care routinely collected from a variety of sources (as per Framework for FDA’s Real-World Evidence Program - Glossary) China: Key(...) Read More
  • RWE
    Real World Evidence (RWE) USA: FDA’s Framework for Real-World Evidence Program- Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD (as per Framework for FDA’s Real-World Evidence Program - Glossary) EU: imi GetReal(...) Read More
  • RWR
    Real World Research (RWR) China: CDA - Real World Research (RWR) refers to the collection of patient-related data in a real-world environment (real-world data), and obtaining clinical evidence (real-world evidence) of the value and potential benefits or risks of the medical products through(...) Read More
  • SaMD
    Software as a Medical Device (SaMD) Global: International Medical Device Regulators Forum (IMDRF) - The term Software as a Medical Device is defined  as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."(...) Read More
  • Single-Arm Clinical Trial
    Single-Arm Clinical Trial China: Key Considerations in Using Real-World Evidence to Support Drug Development - A non-randomized clinical trial where only the experimental group is set up. A single-arm trial, usually uses external controls based on historical data or in a parallel manner (as(...) Read More
  • SOC
    Standard of Care EU: imi GetReal Glossary - Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent physician in the same field would provide under similar circumstances (Source: imi GetReal Glossary – 25 Oct 2016 Adapted(...) Read More
  • Software as a Medical Device
    Software as a Medical Device Global: International Medical Device Regulators Forum (IMDRF) - The term Software as a Medical Device is defined  as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."(...) Read More
  • Standard of Care
    Standard of Care EU: imi GetReal Glossary - Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent physician in the same field would provide under similar circumstances (Source: imi GetReal Glossary – 25 Oct 2016 Adapted(...) Read More
  • Standard Terminology
    Standard Terminology Is a set of “terms” that are shared, unambiguously understood and used among users to represent specific data elements in a database. Examples include SNOMED (Systematic Nomenclature of Medicine), IDC-9 and IDC-10, MedDRA (Medical Dictionary for Regulatory Activities) (as(...) Read More
  • Test Article
    Test Article USA: 21 CFR 50 - Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the(...) Read More
  • Total Product Lifecycle
    Total Product Lifecycle USA: FDA - The highly iterative, autonomous, and adaptive nature of adaptive AI/ML technologies requires a new, total product lifecycle (TPLC) regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually improve(...) Read More
  • TPLC
    Total Product Lifecycle (TPLC) USA: FDA - The highly iterative, autonomous, and adaptive nature of adaptive AI/ML technologies requires a new, total product lifecycle (TPLC) regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually(...) Read More
  • True Copy
    True Copy UK: MHRA Guidance on GxP Data Integrity - A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information, including data that describe the context,(...) Read More
  • Validated Scanning Process
    Validated Scanning Process UK: MHRA ‘GXP’ Data Integrity Guidance and Definitions - A process whereby documents / items are scanned as a process with added controls such as location identifiers and OCR so that each page duplicated does not have to be further checked by a human (as per MHRA(...) Read More