This glossary contains common terms and acronyms found in the eLearning. They are sorted in alphabetical order by the full term (not by abbreviation).
|Active Pharmaceutical Ingredient
|The ingredient in a pharmaceutical drug or pesticide that is biologically active.
|Any unwanted effect caused by the administration of drugs. The onset of an adverse event may be sudden or develop over time.
|Anatomic Therapeutic Chemical classification system
|A drug classification system that classifies the active ingredient of drugs according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties.
|Application Programming Interface
|A set of routines, protocols, and tools for building software applications that specifies how software components should interact.
|Attributable, Legible, Contemporaneous, Original, Accurate
|The principles of data integrity. The plus sign denotes the four additions: Complete, Consistent, Enduring, and Available.
|An audit trail (or audit log) is a security-relevant chronological record, set of records, or destination and source of records that provide documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, or event. The records are of importance for the clinical study, as specified by applicable international standards (from the FDA and EMEA).
|Case Report Form
|A printed, optical, or electronic document designed to record all protocol-required information on each study subject.
|The China Personal Information Protection Law
|The data privacy law in China, targeted at personal information protection.
|Clinical Data Acquisition Standards Harmonization
|A standard developed by CDISC that provides guidance to develop the CRF.
|Clinical Data Interchange Standards Consortium
|A global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
|Clinical Data Interchange Standards Consortium Define Extensible Markup Language
|A metadata format defined by CDISC that is sent with every study in each submission, which tells the regulatory authorities what datasets, variables, controlled terms, and other specified metadata were used.
|User roles in Viedoc that give access to Viedoc Clinic, such as Investigators, Monitors, and Data Managers.The clinic roles are study-specific. These roles, and the rights that belong to these roles, can be defined in Viedoc Designer. Each study can have an unlimited number of clinic roles.
|Clinical data manager
|Responsible for the management of the data in the clinical trial. Assists in protocol development and database selection and configuration.
|Clinical Research Associate
|A person employed by the sponsor, or by a CRO, acting on a sponsor’s behalf, who handles most of the administrative responsibilities of a clinical trial, acts as a liaison between investigative site and sponsor, monitors the progress of the investigator’s sites participating in a clinical study, and reviews all data and records before a monitor’s visit.
|A clinical review gives the Monitor the possibility to mark forms as reviewed.
|Clinical Trial Management System
|A Clinical Trial Management System is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
|Code of Federal Regulations
|The codification of the general and permanent rules and regulations by the executive departments and agencies of the U.S. federal government.
|A set of database rows and columns stored in a text file such that the rows are separated by a new line while the columns are separated by a semicolon or a comma.
|An event that occurs separately or parallel to the workflow, for example concomitant medication, adverse event, medical history, dose adjustments, and daily compliance reporting.
|Computerized Systems Used In Clinical Investigations
|A guidance document established by the FDA intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation (that is, electronic records).
|Drugs given to a patient at the same time, or almost at the same time, as the drug under study.
|Contract Research Organization
|A company that contracts with the sponsor to perform one or more of the sponsor’s duties in a trial.
|Coordinated Universal Time
|The primary time standard by which the world regulates clocks and time. Viedoc stores all timestamps in UTC. In the cases when a time zone can be established (for example a specific site scope is selected), the timestamp is displayed with the time zone applied.
|A user role in Viedoc with permission to lock and export data into different formats, view reports and metrics, and add pre-queries.
|A mode in Viedoc specifically used for demonstrations and training new Viedoc users. No real data should ever be entered in Demo mode.
|A user role in Viedoc that can create the setup (design) of the study in Viedoc Designer.
|A user role in Viedoc with permission to upload medical coding dictionaries.
|Drug Information Association
|A global forum for those involved in healthcare product development and lifecycle management to exchange knowledge and collaborate.
|A check of the data that verifies whether the data entered into the form are within a certain range that is specified in Viedoc Designer. If the entered data are outside the specified range, the system will automatically display a message that is defined under Query Message.
|Electronic Case Report Form
|An electronic document designed to record all protocol-required information on each study subject.
|Electronic Common Technical Document
|A standard format for submitting applications, amendments, supplements, and reports to the FDA.
|Electronic Data Capture
|The use of computerized systems to collect clinical trial data in electronic form as opposed to paper form.
|Electronic Investigator Site File
|The digital version of the minimum list of essential documents that a study site needs to maintain throughout a clinical trial. Included documents could be: Clinical Study Protocol, Investigator Brochure, Informed Consent, CVs etc.
|Electronic Patient Reported Outcome
|A patient-reported outcome that is collected by electronic methods. Viedoc Me is the ePRO solution of Viedoc.
|Electronic Trial Master File
|A type of content management system with a collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated.
|A user role in Viedoc that has permission to manage the eTMF application in Viedoc Admin. The eTMF Manager maps Viedoc Clinic roles to eTMF roles. The eTMF Manager also has permission to manage the eTMF structure in Viedoc eTMF.
|A moment when the patient visits or contacts the clinic, or initiates an event through the Viedoc ePRO application Viedoc Me, and data are recorded.
|European Medicines Agency
|A decentralised agency of the European Union (EU) that is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
|European Medicines Agency Good Clinical Practice Inspectors Working Group
|EMA GCP IWG
|The EMA GCP Inspectors Working Group focuses on harmonisation and co-ordination of GCP related activities at Community level. It is involved in the preparation of new and revised guidance on GCP and community procedures relating to inspection.
|Exchange Mechanism Standard
|The exchange mechanism standard is a model for transferring eTMF data between sponsors, CROs, other stakeholders, and vendor systems.
|Extensible Markup Language
|A markup language that defines a set of rules for encoding documents in a format that is both human-readable and machine-readable.
|Food and Drug Administration
|An agency of the U.S. federal government’s Department of Health and Human Services that ensures the safety of foods, pharmaceuticals and other products.
|General Data Protection Regulation
|A regulation in the European Union (EU) law on data protection and privacy in the EU and the European Economic Area (EEA). Primarily aimed to give control to individuals over their personal data and to simplify the regulatory environment for international business by unifying the regulation within the EU.
|Good Automated Manufacturing Practice
|A subcommittee of, and a series of good practice guides on drug manufacturing published by, the International Society for Pharmaceutical Engineering.
|The last major revision of the GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture, released in February 2008.
|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, accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
|Good Manufacturing Practice
|The manufacturing guidelines recommended by the relevant agencies.
|Globally Unique Identifier
|A unique key containing numbers and letters that identifies the study.
|Health Insurance Portability and Accountability Act
|A Privacy Rule that is the first comprehensive Federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule.
|Hyper Text Markup Language
|The standard markup language for documents designed to be displayed in a web browser.
|A system entity that creates, maintains, and manages identity information.
|Independent Ethics Committee
|An institutional review board (IRB).
|When used in randomization: Prognostic factors that might influence the effect of treatment on the subjects.
|Institutional Review Board
|Committee(s) made up of experts and community representatives who review and approve clinical trials to make certain that they fulfill stringent ethical standards to protect subjects’ rights as participants in an experiment.
|International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
|An initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
|International Organization for Standardization
|An organization promoting worldwide proprietary, industrial, and commercial standards.
|Investigational Medicinal Product
|A medicine for research.
|A preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic, or palliative used in a clinical trial. Also abbreviated IMP (Investigational Medicinal Product) and IMD (Investigational Medical Device).
|Investigator Site File
|The minimum list of essential documents that a study site needs to maintain throughout a clinical trial. Included documents could be Clinical Study Protocol, Investigator Brochure, Informed Consent, CVs etc.
|Iyakuhinmei Data File
|A medical coding dictionary used for coding clinical and drug safety data and for reporting safety data to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
|Japanese Pharmaceuticals and Medical Devices Agency
|PMDA (Pharmaceuticals and Medical Devices Agency) is a Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Their obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
|A scripting language, primarily used on the web. It is used to enhance HTML pages and is commonly found embedded in HTML code. Viedoc is using JS to define advanced edit checks, expressions, and comparisons.
|Key Risk Indicator
|In Viedoc Reports, the Key Risk Indicators are the measurement of unfavorable events that can adversely impact a study, and are measured by site.
|A linking form is a form that contains a link to refer to another form. There can be one or more instances of the linked form.
|A linked form is a form that is linked to from another form (a linking form).
|The process of translating reported events like Adverse Events, Medical History and Concomitant Medications in a universal code according to a medical coding dictionary.
|Medical Dictionary for Regulatory Activities
|A medical coding dictionary developed by the Maintenance and Support Services Organization (MSSO). MedDRA is supported by ICH.
|National Medical Products Administration
|The Chinese agency for regulating drugs and medical devices.
|An identifier mechanism for naming any object, concept, or "thing" with a globally unambiguous persistent name.
|Operational Data Model
|A standard for electronic clinical data as defined by CDISC. The highlights of ODM include audit trail, utilization of XML technology, and machine-readable and human-readable data. All information is independent of databases, and storage of ODM is independent of hardware and software.
|When used in randomization: the result after a patient has been randomized, that is, the treatment group or kit number (in case of a blinded output) that the patient is assigned to.
|Patient Reported Outcome
|A health outcome directly reported by the patient who experienced it.
|Portable Document Format Archive
|An ISO-standardized version of the PDF specialized for use in the archiving and long-term preservation of electronic documents.
|Post Marketing Surveillance
|The practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and an important part of the science of pharmacovigilance. Viedoc PMS is Viedoc's electronic data capture solution developed especially for post-marketing surveillance studies.
|The operational technique and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial are met.
|A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the difference among groups by equally distributing people with particular characteristics among all the trial arms.
|Randomization and Trial Supply Management
|A system that unifies the randomization, allocation, and supply management in a clinical trial.
|Representational State Transfer
|A REST API (also known as RESTful API) is an application programming interface (API or web API) that conforms to the constraints of REST architectural style and allows for interaction with RESTful web services.
|Events to the clinic by the patient that are defined in the study protocol. The events can also be subject-initiated through Viedoc Me, the ePRO application.
|Study Data Tabulation Module
|A CDISC standard for how to structure raw data for a submission.
|Security Assertion Markup Language
|An open XML-based standard for exchanging authentication and authorization identities between security domains.
|Security Token Service
|An open standard web service for issuing, validating, renewing, and cancelling security tokens for use with, for example, an API.
|An authentication process that allows a user to access multiple applications with one set of login credentials.
|A clinic or other medical institute visited by subjects and where their data are recorded.
|A user role in Viedoc Admin that can edit the details of their respective sites and invite site users to their sites.
|Software As A Service
|Also known as web-based software, on-demand software, cloud software, and hosted software. Typically accessed by users via a web browser.
|Standard Operating Procedure
|Detailed, written instructions to achieve uniformity of the performance of a specific function.
|The original data when first recorded.
|Source Data Verification
|The process by which data within the CRF is compared to the original source of information (and vice versa).
|All original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in the source documents.
|Any organization that provides the institutional base for clinical trial researchers. This includes commercial groups: pharmaceutical companies, non-profit organizations, universities, and medical centers.
|Statistical Analysis System
|A format used for statistical analysis in the SAS software suite.
|Viedoc users and all staff involved in the clinical trial. In most cases, these terms refer to users of Viedoc Clinic (see also Clinic role).
|The design of the study that covers all the details about how the study is supposed to be performed, such as treatment details, medical examinations and other data to be collected, the workflow, and the Viedoc permissions of the different clinic roles that contribute to the study. The study design is set up in accordance with the clinical trial protocol.
|A user role in Viedoc that has permission to manage the administration of the study in Viedoc Admin. The study manager invites the study crew, adds sites, and applies study designs to sites. This user role is usually assigned to the project manager of the clinical trial.
|A person participating in the clinical trial. Also referred to as patient.
|User roles in Viedoc that are defined by the system and give access to Viedoc Admin and/or Viedoc Designer. Examples are: Study Manager, Site Manager, Designer, Dictionary Manager, Unblinded Statistician.
|Transport Layer Security
|Protocols designed to provide communications security over a computer network.
|Trial Master File
|A type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for clinical trials that may be required for compliance with government regulatory agencies.
|A user role in Viedoc that manages the randomization and kit allocation lists in Viedoc Admin.
|Additional events to the clinic by the patient that are not pre-defined in the study protocol.
|Viedoc Inspection Readiness Packet
|A file that can be downloaded in Viedoc, containing all the information needed to fulfill regulatory expectations.
|World Health Organization Drug Dictionary
|A dictionary maintained and updated by Uppsala Monitoring Centre.