Glossary

*acronym: 1. A word formed from the beginning letters (e.g. ANSI) or a combination of syllables and letters (e.g. MedDRA) of a name or phrase. 2. The short set of letters that identify a clinical study protocol.
510(k): Premarket Notification (PMN) required for certain medical devices
abbreviation: a set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase
absorption: The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes
action letter: An official communication from FDA to an NDA sponsor announcing an agency decision
activation: Enabling an eClinical trial system to capture data; usually used for EDC systems
admission criteria: Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study
adverse drug reaction (ADR): Any noxious and unintended response associated with the use of a drug in humans. 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility.
adverse event (AE): Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product
algorithm: Step-by-step procedure for solving a mathematical problem; also used to describe step-by-step procedures for making a series of choices among alternative decisions to reach a calculated result or decision
alpha error: The likelihood that a relationship observed between 2 variables is due to chance. The probability of a Type 1 error.
amendment: A written description of a change(s) to, or formal clarification of, a protocol
American National Standards Institute (ANSI): Founded in 1918, ANSI itself does not develop standards. ANSI’s roles include serving as the coordinator for U.S. voluntary standards efforts, acting as the approval body to recognize documents developed by other national organizations as American National Standards, acting as the U.S. representative in international and regional standards efforts, and serving as a clearinghouse for national and international standards development information.
analysis dataset: An organized collection of data or information with a common theme arranged in rows and columns and represented as a single file; comparable to a database table
analysis set: A set of subjects whose data are to be included in the main analyses. This should be defined in the statistical section of the protocol.
analysis variables: Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed
anchor: Designation for a planned activity, often marking the transition between epochs or elements of a clinical study plan (e.g., “FPFV—first patient first visit”)
applet: A small application, typically downloaded from a server
application: 1. Computer application: software designed to fill specific needs of a user; for example, software for navigation, project management, or process control. 2. Regulatory application: application made to a health authority to investigate, market, or license a new product or indication. Synonyms: 1. computer application, application software.
approvable letter: An official communication from FDA to an NDA/BLA sponsor that lists issues to be resolved before an approval can be issued
approval (in relation to institutional review boards): The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements
approval letter: An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval
arm: A planned sequence of elements, typically equivalent to a treatment group
assessment: A measurement, evaluation or judgment for a study variable pertaining to the status of a subject
audit: A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s)
audit certificate: Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharmaceutical company)
audit report: A written evaluation by the auditor of the results of the audit
audit trail: A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record.
back translation (natural language): The process of translating a document that was translated from one language to another back to the original language. Used to ensure that consent forms, surveys, and other clinical trial documents will be clear and accurate in the translated form.
background material: Information pertinent to the understanding of a protocol
balanced study: Trial in which a particular type of subject is equally represented in each study group
bandwidth: An indicator of the throughput (speed) of data flow on a transmission path; the width of the range of frequencies on which a transmission medium carries electronic signals. All digital and analog signal channels have a bandwidth.
baseline assessment: Assessment of subjects as they enter a trial and before they receive any treatment
baseline characteristics: Demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered
baseline imbalance: Systematic error in creating intervention groups, such that they differ with respect to prognosis. That is, the groups differ in measured or unmeasured baseline characteristics because of the way participants were selected or assigned.
Bayesian approaches: Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g., treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference.
Bayesian statistics: Statistical approach named for Thomas Bayes (1701–1761) that has among its features giving a subjective interpretation to probability, accepting the idea that it is possible to talk about the probability of hypotheses being true and of parameters having particular values.
beta error: Probability of showing no significant difference when a true difference exists; a false acceptance of the null hypothesis
bias: Situation or condition that causes a result to depart from the true value in a consistent direction. Bias refers to defects in study design or measurement.
bioanalytical assays: Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids
bioavailability: Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.
bioequivalence: Scientific basis on which drugs with the same active ingredient(s) are compared.
Biologics Licensing Application (BLA): An application to FDA for a license to market a new biologic product in the United States.
biomarker: A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
biostatistics: Branch of statistics applied to the analysis of biological phenomena.
blind review: Checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis.
blinded (masked) medications: Products that appear identical in size, shape, color, flavor, and other attributes to make it very difficult for subjects and investigators (or anyone assessing the outcome) to determine which medication is being administered.
blinded study: A study in which the subject, the investigator, or anyone assessing the outcome is unaware of the treatment assignment(s)
blinding: A procedure to limit bias by preventing subjects and/or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation.
branch: Point within a study design where there is an allocation of subject subsets to particular procedures or treatment groups.
browser: Computer program that runs on the user’s desktop computer and is used to navigate the World Wide Web
cache: Storage area on a computer’s hard drive where the browser stores (for a limited time) Web pages and/or graphic elements.
carry-over effect: Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication’s known biological activity.
case history: An adequate and accurate record prepared and maintained by an investigator that records all observations and other data pertinent to the investigation on each individual administered the investigational drug (device or other therapy) or employed as a control in the investigation.
case report form (CRF): 1. A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject. 2. A record of clinical study observations and other information that a study protocol designates must be completed for each subject.
case report tabulations (CRT): In a paper submission, listings of data that may be organized by domain (type of data) or by subject
categorical data: Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories.
causality assessment: An evaluation performed by a medical professional concerning the likelihood that a therapy or product under study caused or contributed to an adverse event.
CDISC Standard (The): CDISC term for a proposed uniform CDISC standard intended to address the full life-cycle of a clinical trial including protocol representation, capture of source data, submission and archiving using a set of fully integrated and consistent models, terms, and controlled vocabularies derived from the current set of CDISC standards.
certified copy: A copy of original information that has been verified as indicated by a dated signature, as an exact copy having all of the same attributes and information as the original.
Certified IRB Professional (CIP): Certification awarded to persons who satisfy the educational and employment requirements and pass an examination conducted by the Applied Research Ethics National Association (ARENA), the membership division of Public Responsibility in Medicine and Research (PRIM&R).
clean database: A set of reviewed data in which errors have been resolved to meet QA requirements for error rate and in which measurements and other values are provided in acceptable units; database that is ready to be locked
clean file: When all data cleaning is completed and database is ready for quality review and unblinding.
client: A program that makes a service request of another program, usually running on a server, that fulfills the request. Web browsers (such as Netscape Navigator and Microsoft Explorer) are clients that request HTML files from Web servers.
clinical benefit: A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a subject feels.
clinical clarification: A query resolution received from the sponsor staff (medical monitors, DSMB monitoring board, etc.)
clinical data: Data pertaining to the medical well-being or status of a patient or subject.
clinical development plan: A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization.
clinical document: A documentation of clinical observations and services.
clinical document architecture: Specification for the structure and semantics of “clinical documents” for the purpose of exchange.
clinical efficacy: Power or capacity to produce a desired effect (i.e., appropriate pharmacological activity in a specified indication) in humans.
clinical pharmacology: Science that deals with the characteristics, effects, properties, reactions, and uses of drugs, particularly their therapeutic value in humans, including their toxicology, safety, pharmacodynamics, and pharmacokinetics (ADME).
clinical research and development: The testing of a drug compound in humans primarily done to determine its safety and pharmacological effectiveness. Clinical development is done in phases, which progress from very tightly controlled dosing of a small number of subjects to less tightly controlled studies involving large numbers of patients.
clinical research associate (CRA): Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study. At some sites (primarily in academic settings), clinical research coordinators are called CRAs.
clinical research coordinator (CRC): 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 and records before a monitor’s visit. Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse.
clinical significance: Change in a subject’s clinical condition regarded as important whether or not due to the test intervention.
clinical study (trial) report: A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report.
clinical trial: A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device).
clinical trial data: Data collected in the course of a clinical trial
clinical trial exemption (CTX): A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application (generally within 35 working days).
clinical trial information: Data collected in the course of a clinical trial or documentation related to the integrity or administration of that data. A superset of clinical trial data.
clinical trial materials: Complete set of supplies provided to an investigator by the trial sponsor.
clinician reported outcome: Clinician assessment of patient outcomes, based on objective or subjective data evaluated by the clinician.
codelist: Finite list of codes and their meanings that represent the only allowed values for a data item
coding: In clinical trials, the process of assigning data to categories for analysis
cognitive debriefing: A qualitative research tool used to determine whether concepts and items are understood by patients in the same way that PRO instrument developers intend.
cohort: 1. A group of individuals who share a common exposure, experience or characteristic. 2. A group of individuals followed-up or traced over time in a cohort study.
cohort study: Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective.
combination product: 1. A product comprising two or more individual products. 2. Two or more separate products packaged together in a single package or as a unit. 3. A product that is packaged separately but is used only with another product.
common data element: A structured item characterized by a stem and response options together with a history of usage that can be standardized for research purposes across studies conducted by and for NIH.
Common Technical Document: A format agreed upon by ICH to organize applications to regulatory authorities for registration of pharmaceuticals for human use.
comparative study: One in which the investigative drug is compared against another product, either active drug or placebo.
comparator (product): An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
Competent Authority (CA): The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States.
complete file: File for which all data cleaning is complete and database is ready for quality review and unblinding.
completion: 1. Subject completion: the case where a subject ceases active participation in a trial because the subject has, or is presumed to have, followed all appropriate conditions of a protocol. 2. Study completion: according to the study protocol, the point at which all protocol-required activities have been executed.
compliance (in relation to trials): Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.
concept: Discrete notion having a single meaning. In a controlled vocabulary a concept is mapped to one or more of the words that convey its meaning.
confidence interval: A measure of the precision of an estimated value. The interval represents the range of values, consistent with the data, that is believed to encompass the “true” value with high probability (usually 95%). The confidence interval is expressed in the same units as the estimate. Wider intervals indicate lower precision; narrow intervals, greater precision.
confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.
confirmatory trial: Phase 3 trial during which the previously revealed actions of a therapeutic intervention are confirmed.
conformity assessment: The process by which compliance with the EMEA’s Essential Requirements is assessed
consent form: Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved.
consumer safety officer (CSO): FDA official who coordinates the review process of various applications.
content validity: The extent to which a variable (for example, a rating scale) measures what it is supposed to measure.
contingent subject trial contact: Planned response to an anticipated but conditional event in a clinical trial.
contract: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
contract research organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
control group: The group of subjects in a controlled study that receives no treatment, a standard treatment, or a placebo.
control (of electronic records): To prepare and maintain case histories and other records for regulated clinical investigations.
control(s): 1. Comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature)] 2. Computer: processes or operations intended to ensure authenticity, integrity, and confidentiality of electronic records.
controlled study: A study in which a test article is compared with a treatment that has known effects. The control group may receive no treatment, active treatment, placebo, or dose comparison concurrent control.
controlled terminology: Synonym for controlled vocabulary.
controlled vocabulary: A finite set of values that represent the only allowed values for a data item. These values may be codes, text, or numeric
coordinating committee: A committee that a sponsor may organize to coordinate the conduct of a multicenter trial.
coordinating investigator: An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial.
correlation: The degree to which two or more variables are related. Typically the linear relationship is measured with either Pearson’s correlation or Spearman’s rho.
covariate (prognostic): Factor or condition that influences outcome of a trial.
CRF data: Subset of clinical trial data that are entered into fields on a CRF.
CRF (paper): Case report form in which the data items are linked by the physical properties of paper to particular pages.
crossover trial: A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products.
curriculum vitae (cv): Document that outlines a person’s educational and professional history.
data: Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means.
data acquisition: Capture of data into a structured, computerized format without a human-to-computer interface (i.e., from another measuring instrument or computerized source). Contrast with data entry, electronic data capture.
data clarification: Answer supplied by the investigator in response to a query.
data clarification form: A form used to query an investigator and collect feedback to resolve questions regarding data.
data collection instrument: A substrate or tool (either electronic or paper) used to record, transcribe, or collect clinical data.
data element: 1. For XML, an item of data provided in a mark up mode to allow machine processing. 2. Smallest unit of information in a transaction. 3. A structured item characterized by a stem and response options together with a history of usage that can be standardized for research purposes across studies conducted by and for NIH.
data encryption standard (DES): A FIPS approved cryptographic algorithm for encrypting (enciphering) and decrypting (deciphering) binary coded information. Encrypting data converts it to an unintelligible form called cipher. Decrypting cipher converts the data back to its original form called plaintext. The standard specifies both enciphering and deciphering operations, which are based on a 64 bit binary number called a key. Unauthorized recipients of the cipher who know the algorithm but do not have the correct key cannot derive the original data algorithmically.
data entry: Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition.
data integrity: A dimension of data contributing to trustworthiness and pertaining to the systems and processes for data capture, correction, maintenance, transmission, and retention. Key elements of data integrity include security, privacy, access controls, a continuous pedigree from capture to archive, stability (of values, of attribution), protection against loss or destruction, ease of review by users responsible for data quality, proper operation and validation of systems, training of users.
data integrity verification: Process of manually supervised verification of data for internal consistency.
data interchange: Transfer of information between two or more parties, which maintains the integrity of the contents of the data for the purpose intended
data item: A named component of a data element. Usually the smallest component
data listing: Set of observations organized by domain.
data management: Tasks associated with the entry, transfer, and/or preparation of source data and derived items for entry into a clinical trial database.
data management conventions: Procedures and policies for data management, e.g., documented procedure(s) for resolving self-evident changes.
data model: Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use. A data model uses symbolic conventions agreed to represent content so that content does not lose its intended meaning when communicated.
data monitoring: Process by which clinical data are examined for completeness, consistency, and accuracy.
data monitoring committee (DMC): Group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing clinical trial. The DMC advises the sponsor regarding the continuing safety of current participants and those yet to be recruited, as well as the continuing validity and scientific merit of the trial.
data quality: A dimension of data contributing its trustworthiness and pertaining to accuracy, sensitivity, validity, and suitability to purpose. Key elements of data quality include attributability, legibility (decipherable, unambiguous), contemporaneousness, originality (i.e., not duplicated), accuracy, precision, completeness, consistency (logical, not out of range).
data security: Degree to which data are protected from the risk of accidental or malicious alteration or destruction and from unauthorized access or disclosure.
data selection criteria: The rules by which particular data are selected and/or transferred between the point of care and the patient record; subsequently, from the patient record to the database; and from database to inclusion in sub-population analyses.
data transformations: Algorithmic operations on data or data sets to achieve a meaningful set of derived data for analysis.
data type: Data types define the structural format of the data carried in the attribute and influence the set of allowable values an attribute may assume.
data validation: 1. Checking data for correctness and/or compliance with applicable standards, rules, and conventions. 2. Process used to determine if data are inaccurate, incomplete, or unreasonable. The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks.
database: A collection of data or information, typically organized for ease and speed of search and retrieval.
database lock: Action taken to prevent further changes to a clinical trial database.
dataset: A collection of structured data in a single file.
decision rule: Succinct statement of how a decision will be reached based upon the expected foreseen clinical benefits in terms of outcomes of the primary endpoint.
Declaration of Helsinki: A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. It was originally adopted by the 18th World Medical Assembly (Helsinki, Finland, 1964) and recently revised (52nd WMA General Assembly, Edinburgh, Scotland, October 2000).
define: XML. Table used by XML review tools to configure a review engine to deal with CDISC standard data for a trial.
demographic data: Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.
dependent variable: Outcomes that are measured in an experiment and that are expected to change as a result of an experimental manipulation of the independent variable(s).
deployment: Readying an electronic clinical trial system for field use by providing or disseminating capture devices, tokens, or passwords for users of an activated system.
derived variable: New variable created as a function of existing variables and/or application of mathematical functions
design: 1. In the context of clinical trials, see design configuration. 2. In the context of eClinical trials systems, a design for an application to support actions on electronic records.
design configuration: Clinical trial design developed to compare treatment groups in a clinical trial.
development plan: An ordered program of clinical trials, each with specific objectives.
direct access: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
direct entry: Recording of data by human or automated action where an electronic record is the original means of capturing the data into an electronic records system without a paper source document. Examples are an individual keying original observations into a system or the automatic recording into the system of the output from measuring devices such as a balance that measures subject’s body weight or an ECG machine.
discontinuation: The act of concluding participation, prior to completion of all protocol-required elements, in a clinical study by an enrolled subject.
discrepancy: The failure of a data point to pass a validation check.
disease: Any deviation from or interruption of the normal structure or function of a part, organ, or system of the body as manifested by characteristic symptoms and signs.
distribution: 1. In statistics, a group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. 2. In pharmacokinetics, the processes that control transfer of a drug from the site of measurement to its target and other tissues.
document (HL7): An ordered presentation of XML elements, possibly including text and tabular analyses, description, and figures. Descriptors for HL7 documents include type, class, and element.
document root: The element in an XML document that contains all other elements; the first element in the document.
document type definition (DTD): XML specification for content and presentation of data and text in a document including definitions for the elements considered to be legal in the document.
documentation: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
domain: A collection of observations with a topic-specific commonality about each subject in a clinical investigation.
domain name: The way a particular Web server is identified on the Internet. For example, www.fda.gov names the World Wide Web (www) server for the Food and Drug Administration, which is a government (.gov) entity.
dosage: The amount of drug administered to a patient or test subject over the course of the clinical study; a regulated administration of individual doses.
dosage form: Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
dosage regimen: The number of doses per given time period; the elapsed time between doses (for example, every six hours) or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time.
dosage strength: 1. Proportion of active substance to excipient, measured in units of volume or concentration. 2. The strength of a drug product tells how much of the active ingredient is present in each dosage.
dose: The amount of drug administered to a patient or test subject at one time or the total quantity administered.
double-blind study: A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows what treatment a subject is receiving.
double-dummy: A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active).
dropout: A subject in a clinical trial who for any reason fails to continue in the trial until the last visit or observation required of him/her by the study protocol.
drug: 1. Article other than food intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the body. Not a device or a component, part, or accessory of a device. 2. Substance recognized by an official pharmacopia or formulary.
drug development process: The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies.
drug product: 1. A dosage form that contains an active drug ingredient or placebo. 2. A finished dosage form as described in regulations.
dynamic HTML: Collective term for a combination of tags and options, style sheets, and programming that allows users to create Web pages in Hypertext Mark-up Language (HTML) that are more responsive to user interaction than previous versions of HTML.
eClinical trial: Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. Synonyms: eClinical study, eClinical investigation.
eCRF: 1. Auditable electronic record designed to capture information required by the clinical trial protocol to be reported to the sponsor on each trial subject. 2. A CRF in which related data items and their associated comments, notes, and signatures are linked electronically.
eCRT: CRTs provided in electronic format for eSubmissions (electronic regulatory submissions).
edit check: An auditable process, usually automated, of assessing the content of a data field against its expected logical, format, range, or other properties that is intended to reduce error.
effect: An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments.
effectiveness: The desired measure of a drug’s influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.
efficacy: The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease at the dose tested and against the illness (and patient population) for which it is designed.
electronic data capture (EDC): The process of collecting clinical trial data into a permanent electronic form.
electronic health record (EHR): An electronic record for health care providers to create, import, store, and use clinical information for patient care, according to nationally recognized interoperability standards.
electronic medical record (EMR): An electronic record for health care providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting.
electronic personal health record (ePHR): An electroni record for individuals to create, import, store, and use clinical information to support their own health
electronic record: Any combination of text, graphics, data, audio, pictorial, or any other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
electronic signature: A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.
element: 1. In trial design, a basic building block for time within a clinical trial comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element. 2. A section of text in an XML document delimited by start and end tags; or, in the case of empty elements (elements with no content, only attributes) indicated by an empty tag.
endpoint: Variable that pertains to the efficacy or safety evaluations of a trial.
enroll: To register or enter a subject into a clinical trial.
enrollment: 1. The act of enrolling one or more subjects. 2. The class of enrolled subjects in a clinical trial.
enrollment (cumulative): Current enrollment as well as any ever-enrolled subjects who have ended participation.
enrollment (current): Subjects actively continuing to participate in a clinical trial as of the current date.
enrollment (target): The number of subjects in a class or group (including the total for the entire trial) intended to be enrolled in a trial.
Enterprise Vocabulary Services (EVS): A U.S. national resource to house and maintain a number of health-related glossaries and controlled vocabularies under strict versioning.
epoch: Interval of time in the planned conduct of a study. An epoch is associated with a purpose (e.g., screening, randomization, treatment, follow-up), which applies across all arms of a study.
ePRO: PRO data initially captured electronically.
equipoise: A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient.
equivalence trial: A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically unimportant.
eSource: Source record that is electronic.
eSource data (electronic source data): Source data captured initially into a permanent electronic record used for the reconstruction and evaluation of a clinical study.
eSource document: The electronic record used to aggregate a particular instance of eSource data items for capture, transmission, storage, and/or display and serving as a source document for a clinical investigation.
essential documents: Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
established name: The official name of a drug substance.
ethnicity: Denotes social groups with a shared history, sense of identity, geography and cultural roots.
European Medicines Agency (EMEA): The regulatory agency for the EU.
evaluable (for efficacy and safety): Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in Efficacy/Safety datasets.
exclusion criteria: List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study.
excretion: The act or process of eliminating waste products from the body
exploratory IND study: A clinical study that is conducted early in Phase 1; involves very limited human exposure and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies)
exploratory study: Phase 1 or 2 study during which the actions of a therapeutic intervention are assessed and measured.
extraction transformation load (ETL): A class of software applications for data extraction, transformation, and loading that are used to implement data interfaces between disparate database systems, often to populate data warehouses.
field: Locus on a data collection instrument (usually a CRF) for recording or displaying a data element.
File Transfer Protocol (FTP): A standard protocol for exchanging files between computers on the Internet
final report: A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.
finding: A meaningful interpretation of data or observations resulting from planned evaluations.
first-in-humans study: The first Phase 1 study in which the test product is administered to human beings.
first subject in (FSI, FPI): The date and time the first subject is enrolled and randomized into a study. The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. Synonym: first patient in.
first subject screened: First subject who signs the informed consent form and is screened for potential enrollment and randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.
first subject treated: First subject who receives the test article or placebo in a clinical investigation.
Food and Drug Administration (FDA): The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.
Form: A collection of items and item groups for capturing and displaying clinical trial data.
frequentist methods: Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation.
frozen: Status of a database, file, or element that has been presumed to be in its final state pending “lock” and where further editing is prevented without “unfreezing.”
gender: Subject self-identification re: masculine/feminine.
generalizability: The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings.
generic name: The drug identifying name to which all branded (proprietary) names for that indication are associated.
global assessment variable: A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator’s overall impression about the state or change in state of a subject.
glossary: A collection of specialized words or terms with their meanings.
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 that the rights, integrity, and confidentiality of trial subjects are protected.
good clinical research practice (GCRP): Term sometimes used to describe GCP.
granularity: Refers to the size of an information unit in relation to a whole.
group sequential design: A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests.
handwritten signature: The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.
harmonized standard: A European Norm (EN) that has been accepted by all Member States and has been published in the Official Journal of the European Communities (OJEC).
health authority: Synonym for regulatory authority.
Health Level 7 (HL7): An ANSIaccredited Standards Developing Organization (SDO) operating in the healthcare arena.
healthcare provider: 1. One who directly or indirectly administers interventions that are designed to improve the physical or emotional status of patients. 2. A person licensed, certified, or otherwise authorized or permitted by law to administer health care in the ordinary course of business or practice of a profession, including a healthcare facility.
healthy volunteer: Subject (not a patient) in a clinical trial.
human subject: Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
Huriet Law: France’s regulations covering the initiation and conduct of clinical trials.
hypertext: Links in a document that permit browsers to jump immediately to another document.
HyperText Markup Language (HTML): A specification of the W3C that provides markup of documents for display in a Web browser.
hypothesis to test: In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value.
impartial witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
inclusion criteria: The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study.
independent data monitoring committee (IDMC): A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial.
independent ethics committee (IEC): An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
indication: A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials.
informed consent: An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. Informed consent is an ongoing, interactive process, rather than a onetime information session.
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 clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
institution (medical): Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
institutional review board (IRB): An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
instrument: A means to capture data (e.g., questionnaire, diary) plus all the information and documentation that supports its use.
intention-to-treat: The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment given.
inter-rater reliability: The property of scales yielding equivalent results when used by different raters on different occasions.
interaction (qualitative and quantitative): The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (for example, the center). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor; for a qualitative interaction, the direction of the contrast differs for at least one level of the factor.
interim analysis(es): Analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete.
interim analysis schedule: The time/information points at which interim analyses are planned.
interim clinical trial/study report: A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial.
internal consistency: Pertaining to data that do not include contradictions.
Internet: A global system of computer networks that provides the common TCP IP infrastructure for email, the World Wide Web, and other online activities.
Internet service provider (ISP): A company that provides access to the Internet for individuals and organizations.
interoperability: Ability of two or more systems or components to exchange information and to use the information that has been exchanged.
intervention: The drug, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study: e.g., health-related quality of life, efficacy, safety, pharmacoeconomics.
investigational product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
investigational treatment: An intervention under investigation in a clinical study.
investigator: An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
investigator/institution: An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements.”
investigator’s brochure: A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.
item: 1. A representation of a clinical variable, fact, concept, or instruction in a manner suitable for communication, interpretation, or processing by humans or by automated means. NOTE: Items are collected together to form item groups.
2. An individual question, statement, or task that is evaluated by the patient to address a particular concept to be measured by a PRO instrument.
item definition: 1. In a questionnaire or form to be completed in a clinical trial, the specification of a question and the specification of the format and semantics of the response. 2. Formal specification of the properties of an item or field of data in an eClinical trial.
item generation: Establishing the content to be covered by the items in a PRO instrument, including generating item wording, evaluating the completeness of item coverage of the concepts of interest, and performing initial assessment of clarity and readability. NOTE. PRO instrument item generation is potentially incomplete without patient involvement.
item group definition: The specification in an eClinical trial of a collection of items often clinically related to each other and useful to consider as an ensemble.
Janus: 1. A logical design conceived by the FDA for a data warehouse intended to integrate submission data, protocol descriptions, and analysis plans from clinical and animal studies into as an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining, and retrospective comparative analysis. 2. The name assigned to a component of the NCI’s caBIG Clinical Research Information Exchange (CRIX) initiative, representing a joint NCI/FDA project to develop a physical implementation of the Janus model.
label: Description of a drug product/device that includes: the indication, who should use it, adverse events, instructions for use, and safety information.
labeling (content of): All text, tables, and figures in labeling as described in regulations for a specific product (e.g., 21 CFR 201.56 and 201.57 for human prescription drugs; 201.66 for human over-the-counter drugs; 21 CFR 801 for medical devices; and 21 CFR 606.122 for blood products)
laboratory (clinical): A laboratory providing analyses of samples collected in clinical care or research.
last subject out/complete (LSC/LPC or LSO/LPO): 1. The date and time when the last subject has reached a planned or achieved milestone representing the completion of the trial. 2. The last subject to complete a trial
last subject/patient in (LSI/LPI): Date and time when the last subject to participate in a clinical trial is enrolled
legal authentication: A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document.
legally acceptable representative: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.
Leiter der klinischen Prüfung: Under the German Drug Law, the physician who is head of the clinical investigation.
life-threatening adverse event/experience: Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death.
longitudinal study: Investigation in which data are collected from a number of subjects over a long period of time (a well-known example is the Framingham Study).
mapping: In the context of representing or exchanging data, connecting an item or symbol to a code or concept.
marketing support trials: Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decisionmakers the rationale for preferring one therapy over another.
markup: Computer-processable annotations within a multimedia document.
matched-pair design: A type of parallel trial design in which investigators identify pairs of subjects who are “identical” with respect to relevant factors, then randomize them so that one receives Treatment A and the other Treatment B
mean: The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.
median: The middle value in a data set; that is, just as many values are greater than the median and lower than the median value. (With an even number of values, the conventional median is halfway between the two middle values.)
medical monitor: A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.
medicinal product: Synonym for therapeutic intervention, but usually a drug.
Medicines and Healthcare products Regulatory Agency (MHRA): The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
mega-trials: Massive clinical trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects.
Memorandum of Understanding (MOU): A formal agreement between the Food and Drug Administration (FDA) and federal, state, or local government agencies; academic institutions; and other entities.
message (HL7): The atomic unit of data transferred between systems. It comprises a group of segments in a defined sequence. Each message has a message type that defines its purpose.
meta-analysis: The formal evaluation of the quantitative evidence from two or more trials bearing on the same question.
metabolism: The biochemical alteration of substances introduced into the body.
metadata: Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields.
migration: The act of moving a system or software product (including data) from an old to new operational environment in accordance with a software quality system.
missing data: 1. Data not completed, or corrupted in reports and case report forms. 2. Particularly the data not captured when a subject withdraws from a trial.
mode: The most frequently occurring value in a data set.
model: A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context, e.g., clinical trial data.
modem: From modulator/ demodulator; a device that converts digital data into analog data that can be transmitted via telephone or cable lines used for communications.
monitor: Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol and GCP guidance.
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), good clinical practice (GCP), and the applicable regulatory requirement(s).
monitoring 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.
monitoring visit: A visit to a study site to review the progress of a clinical study and to ensure protocol adherence, accuracy of data, safety of subjects, and compliance with regulatory requirements and good clinical practice guidelines.
multicenter trial: Clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.
n-of-1 study: A trial in which an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment’s effect in that person, often with the order of experimental and control treatments randomized.
natural language: Language as used in ordinary communications among humans and distinguished from controlled terminologies and structured languages used exclusively for communication and interoperability among machines.
New Drug Application (NDA): An application to FDA for a license to market a new drug in the United States.
nomenclature: Application of naming conventions.
nonclinical study: Biomedical studies not performed on human subjects.
not approvable letter: An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected.
Notified Body (NB): A private institution charged by the Competent Authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB.
null hypothesis: The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained.
Nuremberg Code: Code of ethics, set forth in 1947, for conducting human medical research.
objective: The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial.
objective measurement: A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment
observation: 1. An assessment of patient condition or analysis of data collected on an individual patient or group of patients. 2. (SDTM) A discrete piece of information collected during a study.
observer assessment: An assessment of patient condition made by an observer (investigator, nurse, clinician, family member, etc.).
ontology: An explicit formal specification of how to represent relationships among objects, concepts, and other entities that belong to a particular domain of experience or knowledge
open-label study: A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study.
open to enrollment: The status of a study such that a subject can be enrolled into that study.
operational model: The set of CDISC data standards (including ODM and LAB) used to capture and archive data from clinical trials.
opinion (in relation to independent ethics committee): The judgment and/or the advice provided by an independent ethics committee.
origin: 1. Source of information collected in the course of a clinical trial. Specifically used to differentiate between data collected at point of patient contact and data that are derived or calculated. 2. (SDTM) A metadata attribute defined for each dataset variable in the “Define” document of an SDTM submission that refers to the source of a variable (e.g., CRF, derived, sponsor defined, PRO, etc.).
original data: The first recorded study data values.
outcome: 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. (SDTM) The result of carrying out a mathematical or statistical procedure.
outcome (of adverse event): Refers to the resolution of an adverse event.
outcomes research: Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions.
outliers: Values outside of an expected range.
p-value: Study findings can also be assessed in terms of their statistical significance. The p-value represents the probability that the observed data (or a more extreme result) could have arisen by chance when the interventions did not differ.
packaging: The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.
pairing: A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B
parallel trial: Subjects are randomized to one of two or more differing treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial.
parameter: A variable in a model, or a variable that wholly or partially characterizes a probability distribution (mathematics and statistics).
participant: A person or entity with a role in healthcare or a clinical study.
password aging: A practice applying to multi-user computer systems where the validity of a password expires after a certain pre-set period.
patient: Person under a physician’s care for a particular disease or condition.
patient file: One that contains demographic, medical, and treatment information about a patient or subject. It may be paper- or computer-based or a mixture of computer and paper records.
patient-reported outcome (PRO): Information coming directly from patients or subjects through interviews or self-completed questionnaires or other data capture tools such as diaries about their life, health condition(s), and treatment.
per-protocol analysis set: The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model.
performed activity: Clinical trial events as they actually occurred (as compared with events planned in the protocol).
period effect: An effect occurring during a period of a trial in which subjects are observed and no treatment is administered.
permanent data: Data that become or are intended to become part of an electronic record in relation to a regulatory submission.
permissible values: Limited universe of options for data items. (e.g., drop-down menus, codelists, pick lists).
pharmacodynamics: Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents.
pharmacoeconomics: Branch of economics that applies cost-benefit, cost-utility, cost-minimization, and cost-effectiveness analyses to assess the utility of different pharmaceutical products or to compare drug therapy to other treatments.
pharmacogenetic test: An assay intended to study interindividual variations in DNA sequence related to drug absorption and disposition or drug action.
pharmacogenetics: Study of the way drugs interact with genetic makeup or the study of genetic response to a drug.
pharmacogenomic test: An assay intended to study interindividual variations in wholegenome or candidate gene maps, biomarkers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response.
pharmacogenomics: Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to predict whether a person will respond favorably, adversely, or not at all to an investigational product.
pharmacokinetics: Study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of medicinal products.
pharmacology: Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.
pharmacovigilance: Term used for adverse event monitoring and reporting.
phase: One in a set of successive stages in a progression or sequence such as 1. a step in the progression of a therapy from initial experimental use in humans to postmarket evaluation. 2. a stage in the conduct of a clinical trial.
Phase 4: Postmarketing (Phase 4) studies to delineate additional information about the drug’s risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval.
Phase 3: Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit–risk relationship of the drug and to provide an adequate basis for physician labeling.
Phase 2: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.
Phase 0: First-in-human trials, in a small number of subjects, that are conducted before Phase 1 trials and are intended to assess new candidate therapeutic and imaging agents. The study agent is administered at a low dose for a limited time, and there is no therapeutic or diagnostic intent.
Phase 5: Postmarketing surveillance is sometimes referred to as Phase 5
Phase 1: The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects.
Phase 2A: Controlled clinical studies that occur after the completion of Phase 1 studies and the first set of exposure-response studies in patients, and before beginning Phase 2B (i.e., patient dose-ranging trial) and Phase 3 clinical efficacy-safety studies.
Phase 3B: A subcategory of Phase 3 trials done near the time of approval to elicit additional findings.
placebo: A pharmaceutical preparation that does not contain the investigational agent. In blinded studies, it is generally prepared to be physically indistinguishable from the preparation containing the investigational product.
population: Any finite or infinite collection of subjects from which a sample is drawn for a study to obtain estimates for values that would be obtained if the entire population were sampled.
postmarketing surveillance: Ongoing safety monitoring of marketed drugs
pragmatic trial: Term used to describe a clinical study designed to examine the benefits of a product under real world conditions.
Pre-Market Approval Application (PMA): An application to FDA for a license to market a new device in the United States.
preamble: A section preceding the text of a final FDA regulation published in the Federal Register.
preclinical studies: Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP).
primary objective: The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing).
primary variable: An outcome variable specified in the protocol to be of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation.
product: 1. Drug product: A finished dosage form that contains a drug substance. 2. A physical entity that is intended to diagnose, treat, or prevent a disease or other abnormal condition, and subject to regulatory authority.
PROMIS: NIH-sponsored project for the development and evaluation of PRO item banks and computer adaptive testing for pain, fatigue, physical function, social function, and emotional well-being.
proprietary name: A commercial name granted by a naming authority for use in marketing a drug/device product.
prospective study: Investigation in which a group of subjects is recruited and monitored in accordance with criteria described in a protocol.
protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
protocol amendment(s): A written description of a change(s) to or formal clarification of a protocol.
protocol approval (Sponsor): Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated.
protocol deviation: A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor.
Protocol Identifying Number: Any of one or more unique codes that refers to a specific protocol.
protocol referenced documents: Protocol referenced documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial.
protocol title: Three categories of protocol title have evolved to address distinct standardized use cases. 1) Scientific Title: A comprehensive summary of study design and objectives, aimed at scientific audience. 2) Public Title: A brief description intended for the lay public in easily understood language. 3) Trial Acronym: Brief popular identifier.
protocol violation: A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a perprotocol analyis, and may require that the subject(s) who violate the protocol be discontinued from the study.
proxy (as an origin of outcome measures): A proposed standardized qualifier variable to describe the origin of observations of the Findings class resulting from outcomes measures. Proxy describes outcome data furnished by someone other than the patient and distinguishes the origin of the outcome from a self-report (PRO) directly from the patient.
proxy respondent: Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer.
psychometric validation: The specialized process of validating questionnaires used in outcomes research to show that they measure what they purport to measure.
psychometrics: The science of assessing the measurement characteristics of scales that assess human psychological characteristics.
qualitative variable: One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categories according to their attributes.
quality assurance (QA): All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s).
quality control (QC): The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.
quality of life: A broad ranging concept that incorporates an individual’s physical health, psychological state, level of independence, social relationships, personal beliefs, and their relationships to salient features of the environment.
quantitative variable: One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum.
query: A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review.
query management: Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data.
query resolution: The closure of a query usually based on information contained in a data clarification.
questionnaire: A set of questions or items shown to a respondent in order to get answers for research purposes.
random allocation: Assignment of subjects to treatment (or control) groups in an unpredictable way.
random number table: Table of numbers with no apparent pattern used in the selection of random samples for clinical trials.
random sample: Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection.
randomization: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
raw data: Data as originally collected. Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations. Researcher’s records of subjects/patients, such as patient medical charts, hospital records, X-rays, and attending physician’s notes.
RCRIM: Regulated Clinical Research and Information Management, which is a Technical Committee within HL7 (an acronym pronounced “arcrim”).
reconstruction (of a study): For eClinical trials FDA expects archival trial records to support review of the data as well as the processes used for obtaining and managing the data so that the trustworthiness of results obtained can be evaluated.
recruitment (investigators): Process used by sponsors to identify, select, and arrange for investigators to serve in a clinical study.
recruitment period: Time period during which subjects are or are planned to be enrolled in a clinical trial.
recruitment (subjects): Process used by investigators to find and enroll appropriate subjects (those selected on the basis of the protocol’s inclusion and exclusion criteria) into a clinical study.
recruitment target: Number of subjects that must be recruited as candidates for enrollment into a study to meet the requirements of the protocol. In multicenter studies, each investigator has a recruitment target.
Reference Information Model (RIM): An information model used as the ultimate defining reference for all HL7 standards.
registry: A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
regulatory authorities: Bodies having the power to regulate.
reliability, psychometric: The degree to which a psychometric “instrument” is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time.
repeat rule: Guide for repeating activities specified in protocol, including such features as the number of cycles and the criteria for stopping.
replacement: The act of enrolling a clinical trial subject to compensate for the withdrawal of another.
research hypothesis: The proposition that a study sets out to support (or disprove); for example, “blood pressure will be lowered by
response option: One of several choices to be available for selection in response to a prompt, question or instruction (i.e., a stem) in a PRO item
retrospective: Capture of clinical trial data is retrospective when it is recalled from memory rather than captured contemporaneously in realtime.
risk: In clinical trials, the probability of harm or discomfort for subjects.
role: 1. The function or responsibility assumed by a person in the context of a clinical study. Examples include data manager, investigator. 2. Classifier for variables that describe “observations” in the SDTM. Role is a metadata attribute that determines the type of information conveyed by an observation-describing variable and standardizes rules for using the describing variable.
safety: Relative freedom from harm. In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects.
safety and tolerability: The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs, and symptoms), and other special safety tests (e.g., ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject.
sample size: 1. A subset of a larger population, selected for investigation to draw conclusions or make estimates about the larger population. 2. The number of subjects in a clinical trial. 3. Number of subjects required for primary analysis.
sample size adjustment: An interim check conducted on blinded data to validate the sample size calculations or re-evaluate the sample size.
schedule of activities: A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g,. obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments.
schedule of assessments: A tabular representation of planned protocol events and activities, in sequence.
screen failure: Potential subject who did not meet one or more criteria required for participation in a trial
screen/screening (of substances): Screening is the process by which substances are evaluated in a battery of tests or assays (screens) designed to detect a specific biological property or activity. It can be conducted on a random basis in which substances are tested without any preselection criteria or on a targeted basis in which information on a substance with known activity and structure is used as a basis for selecting other similar substances on which to run the battery of tests.
screening (of sites): Determining the suitability of an investigative site and personnel to participate in a clinical trial.
screening (of subjects): A process of active consideration of potential subjects for enrollment in a trial
screening trials: Trials conducted to detect persons with early, mild, and asymptomatic disease.
script: A program or a sequence of instructions that are interpreted or carried out by another program or by a person.
secondary sponsor: Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship.
secondary variable: The primary outcome is the outcome of greatest importance. Data on secondary outcomes are used to evaluate additional effects of the intervention.
self-evident change: A data discrepancy that can be easily and obviously resolved on the basis of existing information on the CRF, e.g., obvious spelling errors or the patient is known to be a male and a date of last pregnancy is provided
semantic: In the context of a technical specification, semantic refers to the meaning of an element as distinct from its syntax. Syntax can change without affecting semantics.
serious adverse event (SAE) or serious adverse drug reaction (serious ADR): Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
serious adverse experience: Any experience that suggests a significant hazard, contra-indication, side effect or precaution
server: A computer that controls a central repository of data, files, and/or applications that can be accessed and/or manipulated in some manner by client computers. A file server hosts files for use by client machines. An application server runs programs that may process and display data exchanged with client machines. After the arrival of the Web, server often refers to software and computers that perform database queries and collect and present timely data to users running browsers or other client applications.
sex: Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other.
side effects: Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects
single-blind study: A study in which one party, either the investigator or the subject, does not know which medication or placebo is administered to the subject; also called singlemasked study
site investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
software: Computer programs, procedures, rules, and any associated documentation pertaining to the operation of a system.
software validation: Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.
source: 1. The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. 2. Sometimes used as shorthand for source documents and/or source data.
source data: All information in 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 source documents (original records or certified copies).
source data verification: The process of ensuring that data that have been derived from source data accurately represent the source data.
source document verification: The process by which the information reported by an investigator is compared with the source records or original records to ensure that it is complete, accurate and valid.
source documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medicotechnical departments involved in the clinical trial)
special populations: Subsets of study populations of particular interest included in clinical trials to ensure that their specific characteristics are considered in interpretation of data (e.g., geriatric).
sponsor: 1. An individual, company, institution, or organization that takes responsibility for the initiation and management of a clinical trial, although may or may not be the main funding organization. If there is also a secondary sponsor, this entity would be considered the primary sponsor. 2. A corporation or agency whose employees conduct the investigation is considered a sponsor and the employees are considered investigators.
sponsor-investigator: An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject.
standard: Criterion or specification established by authority or consensus for 1. measuring performance or quality; 2. specifying conventions that support interchange of common materials and information.
standard deviation: Indicator of the relative variability of a variable around its mean; the square root of the variance.
standard of care: A guideline for medical management and treatment.
standard operating procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.
standard treatment: A treatment currently in wide use and approved by the FDA or other health authority, considered to be effective in the treatment of a specific disease or condition.
statistical analysis plan: A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.
statistical method: The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial.
statistical significance: State that applies when a hypothesis is rejected. Whether or not a given result is significant depends on the significance level adopted. For example, one may say “significant at the 5% level.” This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it.
stem: The prompt, question or instruction in a PRO item
stochastic: Involving a random variable; involving chance or probability.
stopping rules: A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary.
stratification: Grouping defined by important prognostic factors measured at baseline
structured product label (SPL): The Structured Product Labeling (SPL) specification is an HL7 ANSI-approved document markup standard that specifies the structure and semantics for the exchange of product information.
study description: Representation of key elements of study (e.g., control, blinding, gender, dose, indication, configuration).
study design: Plan for the precise procedure to be followed in a clinical trial, including planned and actual timing of events, choice of control group, method of allocating treatments, blinding methods; assigns a subject to pass through one or more epochs in the course of a trial. Specific design elements, e.g., crossover, parallel; dose-escalation
study design rationale: Reason for choosing the particular study design.
study design schematic: Schematic diagram (not tabular) of study design, procedures and stages.
study initiation date: Date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria.
study population: Defined by protocol inclusion/exclusion criteria.
study start: The formal recognition of the beginning of a clinical trial that is referred to in the clinical study report.
study variable: A term used in trial design to denote a variable to be captured on the CRF
sub-investigator: Any 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., associates, residents, research fellows).
subject data event: A subject visit or other encounter where subject data are collected, generated, or reviewed.
subject identification code: A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial-related data.
subject-reported outcome (SRO): An outcome reported directly by a subject in a clinical trial.
subject trial contact: Any activity, anticipated in the study protocol, involving a subject and pertaining to collection of data.
subject/trial subject: An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control.
submission model: A set of data standards (including SDTM, ADaM, and define.xml) for representing data that are submitted to regulatory authorities to support product marketing applications.
superiority trial: A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control).
supplier: An organization that enters into a contract with the acquirer for the supply of a system, software product, or software service under the terms of a contract.
surrogate marker: A measurement of a drug’s biological activity that substitutes for a clinical endpoint such as death or pain relief.
surrogate variable: A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical.
survey: Any means (e.g., questionnaire, diary, interview script, group of items) that is used to collect PRO data.
synopsis: Brief overview, prepared at the conclusion of a study as a routine part of a regulatory submission, summarizing the study plan and results; includes numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc.
syntactic: The order, format, content of clinical trial data and/or documents as distinct from their meaning.
system: People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives.
t-test: A statistical test used to compare the means of two groups of test data.
table of roles and responsibilities: A cumulative record documenting operational access and authorizations of study personnel to electronic systems used in eClinical trials.
tabulation dataset: A dataset structured in a tabular format.
target enrollment: The number of subjects in a class or group (including the total for the entire trial) intended to be enrolled in a trial to reach the planned sample size. Target enrollments are set so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by agreement, algorithm, or other specified process.
target study population: Demographic and health condition of the population to be included in a clinical study.
technology provider: A person, company, or other entity who develops, produces, and sells software applications and/or hardware for use in conducting clinical trials and/or in analyzing clinical trial data and or submitting clinical trial information for regulatory approval.
term: One or more words designating something.
termination (of subject): Now considered nonstandard.
termination (of trial): Premature discontinutation of a trial prior to plan.
terminology: 1. Set of concepts, designations, and relationships for a specialized subject area. See Glossary. 2. In the context of clinical research in human subjects, a standardized, finite set of terms (e.g., picklists, medDRA codes) that denote patient findings, circumstances, events, and interventions.
token: Physical key that provides access to a secure electronic system or location.
transcription: Process of transforming dictated or otherwise documented information from one storage medium to another.
transition rule: A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan.
translation: Converting information from one natural language to another while preserving meaning.
transmit: To transfer data, usually electronically.
treatment effect: An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments.
treatment-emergent adverse event: An event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.
Trial Design Model: Defines a standard structure for representing the planned sequence of events and the treatment plan of a trial.
trial monitoring: Oversight of quality of study conduct and statistical interim analysis.
trial site: Synonym for investigative site, investigator site, site, site of the trial, study site.
trial statistician: A statistician who has a combination of education/ training and experience sufficient to implement the principles in the ICH E9 guidance and who is responsible for the statistical aspects of the trial.
trial subject: Subject in a clinical trial
triple-blind study: A study in which knowledge of the treatment assignment(s) is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators.
trustworthy (electronic records): An attribute of records (data and documents) and signatures submitted to regulatory agencies referring to their suitability for making scientific findings of safety and efficacy that underlie public policy decisions pertaining to market authorization. Two key dimensions that determine the trustworthiness of eClinical trial data are data quality and data integrity.
type of comparison: How treatment arms will be compared (e.g., Safety, Efficacy, PK/PD). May also include comparison to data from other studies or sources (e.g., historical control).
type 1 (or type I) error: Error made when a null hypothesis is rejected but is actually true.
type 2 (or type II) error: Error made when an alternative hypothesis is rejected when it is actually true.
type 3 (or type III) error: Some statisticians use this designation for an error made when calling the less effective treatment the more effective one.
unblinding: Identification of the treatment code of a subject or grouped results in studies where the treatment assignment is unknown to the subject and investigators.
unexpected adverse drug reaction: An adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.
uniform resource locator (URL): Address of a Web page, actmagazine.com, for example.
use case: An explicit scenario designed to help in determining whether a system/process is capable of performing the functions required for a particular use. A use case might describe, for example, how a study coordinator would use a tablet computer to capture medical history data.
user site testing (UST): Any testing that takes place outside of the developer’s controlled environment.
valid: 1. Sound. 2. Well grounded on principles of evidence. 3. Able to withstand criticism or objection.
validation: 1. Process of establishing suitability to purpose. 2. For software and systems, establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
validation of data: 1. A process used to determine if data are inaccurate, incomplete, or unreasonable. The process may include format checks, completeness checks, check key tests, reasonableness checks and limit checks. 2. The checking of data for correctness or compliance with applicable standards, rules, and conventions.
variable: 1. Any entity that varies; any attribute, phenomenon, or event that can have different qualitative or quantitative values. 2. In SDTM “variables” are used to describe observations. Such describing variables have roles that determine the type of information conveyed by the variable about each observation and how it can be used.
variance: A measure of the variability in a sample or population. It is calculated as the mean squared deviation (MSD) of the individual values from their common mean. In calculating the MSD, the divisor n is commonly used for a population variance and the divisor n-1 for a sample variance.
verification: 1. The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements. 2. (of software). Provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase.
visit: A clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject. A visit has a start and an end, each described with a rule.
vocabulary: Terms that function in general reference to concepts that apply over a variety of languages are words, and their totality is a vocabulary.
volunteer: A person volunteering to participate as a subject in a clinical trial, often a healthy person agreeing to participate in a Phase 1 trial
vulnerable subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
Warning Letter: A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice.
washout period: A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated).
Web browser: A computer program that interprets HTML and other Internet languages and protocols and displays Web pages on a computer monitor.
Web page: A single page on a Web site, such as a home page.
Web server: A computer server that delivers HTML pages or files over the World Wide Web
Web site: A collection of Web pages and other files. A site can consist of a single Web page, thousands of pages, or custom created pages that draw on a database associated with the site.
weighting: An adjustment in a value based on scientific observations within the data.
well-being (of the trial subjects): The physical and mental integrity of the subjects participating in a clinical trial.
withdrawal: The subject-initiated act of discontinuing participation in a clinical study.
within-subject differences: In a crossover trial, variability in each subject is used to assess treatment differences.
World Wide Web: All the resources and users on the Internet that are using HTTP protocols. Also called the Web and www.

Improvements Coming

The listing above is produced from a simple SPARQL query of on the CDISC SPARQL endpoint. Improvements are coming …

improve the CDISC graph. Currently ala the paper form from CDISC, multiple definitions appear in the same clause (predicate). Reference fields (not yet shown above) such as synonym or see are now labels. They need to become URIs.
distinguish IT from Health-Care specific terms. CDISC’s strength is Health-Care. Many of its glossary’s generic IT terms (Dynamic HTML etc.) are defined more comprehensively elsewhere. The hoot72 glossary should get its definitions of such terms directly from those places and not show CDISC’s versions.
highlight the redefinition of common words in Health-care (”protocol” etc.). This will draw on WordNet.
distinguish acronyms and abbreviations. CDISC makes note of the difference using definitions but doesn’t mark entries as one or the other.
note the “coiner” of terms - CDISC just notes the source of its definition which may not be the same thing. Take the “FDA” - many may just be interested in browsing the terms they coined.
evaluate SKOS for these glossary graphs.

hoot72

Glossary

Improvements Coming