CDISC Clinical Research Glossary - Glossary Terms
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Special Resource Issue
CDISC Clinical Research Glossary
Glossary Terms
CDISC Glossary Project
510(k). Premarket Notification (PMN)
required for certain medical devices. Arthur Gertel, Project Leader
See http://www.fda.gov/cdrh/510k Glossary Project Core Team:
home.html. Patricia Beers Block, Medidata Solutions Consulting; Stephen A. Raymond, PHT
abbreviation. A set of letters that Inc; Helle-Mai Gawrylewski, Johnson and Corporation; Erin Muhlbradt, PhD, Lock-
are drawn from a word or from a Johnson PRD; Arthur Gertel, Beardsworth heed Martin; Yiying (CoCo) Tsai, FDA
sequence of words and that are used
for brevity in place of the full word Orientation: The following glossary is document verification” would appear
or phrase. NOTE: An abbreviation is produced by the Glossary Project of under “source,” not “verification.”
NOT pronounced as a word, but each CDISC, which seeks to harmonize The glossary follows the practice of
letter is read in sequence (e.g., NIH). definitions (including acronyms, preceding certain terms with the letter
Compare to acronym. abbreviations, and initials) used in the “e” to denote that they pertain to
various standards initiatives electronic or web implementation. Each
absorption. The process by which undertaken by CDISC in clinical term in the glossary has the following
medications reach the blood stream research. The purpose of the CDISC conventions concerning content and
when administered other than Glossary is also to serve the community order of presentation:
intravenously, for example, through of clinical researchers by selecting and
nasal membranes. See also ADME defining terms pertaining to clinical Term. The word or phrase being
(pharmacokinetics). research, particularly eClinical defined is followed by a period. Only
acronym. 1. A word formed from investigations, sponsored by the proper nouns are capitalized.
the beginning letters (e.g., ANSI) or pharmaceutical industry or a federal
agency. The glossary is publicly Definition. Multiple meanings of the
a combination of syllables and letters
accessible on the CDISC website (CDISC. same term are numbered 1., 2., 3., etc.
(e.g., MedDRA) of a name or phrase.
2. The short set of letters that identify org), where comments on the glossary
NOTE: Comments including usage or
a clinical study protocol. NOTE: An are welcomed.
domain knowledge related to a term
acronym is usually pronounced as a may follow the definition.
Note that this CDISC Glossary is
word, not by speaking each letter
NOT comprehensive for all words
individually. Compare to abbreviation. Source(s). The sources for definitions
bearing on human health, medicine,
or laboratory methods. The glossary are cited (see “Reference Citations”)
action letter. An official
includes references and links to in square brackets. Where the
communication from FDA to an
other glossaries such as regulatory definition has been altered by CDISC,
NDA sponsor announcing an agency
dictionaries and to health-related the citation states “modified from.”
decision. See also approval letter,
approvable letter, not-approvable letter. controlled terminologies that are Where the definition has been drawn
known to be useful in conducting by CDISC from text that is not itself a
activation. Enabling an eClinical trial clinical research, including the CDISC definition, the citation states “after”
system to capture data; usually used for Terminology Project. or “from.” Where no source is listed,
EDC systems. the definition is from CDISC.
Glossary terms are organized
admission criteria. Basis for alphabetically by first word according Related terms. Some definitions offer
selecting target population for a clinical to the opinion of the Glossary Project synonyms (See), comments, or related
trial. Subjects must be screened to Team concerning most common usage terms (See also or Compare to) to
ensure that their characteristics match a in clinical research. Thus “source sharpen or expand upon the definition.
list of admission criteria and that none
of their characteristics match any single
one of the exclusion criteria set up for
adverse drug reaction (ADR). in man for prophylaxis, diagnosis, or
the study. See also inclusion criteria,
Any noxious and unintended response therapy of diseases or for modification of
exclusion criteria.
associated with the use of a drug in physiological function. 2. Pre-approval:
adverse drug experience. humans. 1. Post-approval: an adverse an adverse event that occurs at any
See adverse drug reaction. event that occurs at doses normally used dose and where a causal relationship is
December 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 11Special Resource Issue CDisc Clinical Research Glossary
at least a reasonable possibility. NOTE: procedures for making a series of impossible to know the person
FDA 21 CFR 310.305 defines an adverse choices among alternative decisions to with whom the data are associated.
drug experience to include any adverse reach a calculated result or decision. Applicable particularly for secondary use
event, “whether or not considered to of health data. See de-identified. [After
be drug-related.” CDISC recognizes that alpha error. The likelihood that HITSP]
current usage incorporates the concept a relationship observed between
of causality. [WHO Technical Report two variables is due to chance. The applet. A small application, typically
498(1972); ICH E2A] probability of a Type 1 error. [Modified downloaded from a server.
from AMA Manual of Style]
adverse event (AE). Any untoward application software. See
medical occurrence in a patient amendment. A written description of application.
or clinical investigation subject a change(s) to, or formal clarification of,
a protocol. application. 1. Computer application:
administered a pharmaceutical product software designed to fill specific needs
and which does not necessarily have a American National Standards of a user; for example, software for
causal relationship with this treatment. Institute (ANSI). Founded in 1918, navigation, project management,
An adverse event (AE) can therefore ANSI itself does not develop standards. or process control. 2. Regulatory
be any unintended sign (including an ANSI’s roles include serving as the application: application made to a
abnormal laboratory finding), symptom, coordinator for US voluntary standards health authority to investigate, market,
or disease temporally associated with efforts, acting as the approval body or license a new product or indication.
the use of a medicinal (investigational) to recognize documents developed Synonyms: 1. computer application,
product, whether or not related to the by other national organizations as application software.
medicinal (investigational) product. American National Standards, acting as
NOTE: For further information, see the US representative in international approvable letter. An official
the ICH Guideline for Clinical Safety and regional standards efforts, communication from FDA to an NDA/
Data Management: Definitions and and serving as a clearinghouse for BLA sponsor that lists issues to be
Standards for Expedited Reporting. national and international standards resolved before an approval can be
“[Modified from ICH E2A]” Synonyms: development information. [HL7] issued. [Modified from 21 CFR 314.3;
side effect, adverse experience. See Guidance to Industry and FDA Staff
also serious adverse event, serious analysis dataset. An organized (10/08/2003)]
adverse experience. collection of data or information with a
common theme arranged in rows and approval (in relation to
adverse experience. See adverse columns and represented as a single institutional review boards). The
event. file; comparable to a database table. affirmative decision of the IRB that the
NOTE: Standardizing analysis datasets is clinical trial has been reviewed and may
adverse reaction. See adverse drug be conducted at the institution site
reaction. intended to make review and assessment
of analysis more consistent [ADaM]. within the constraints set forth by the
alert. To cause a high-priority signal IRB, the institution, good clinical practice
(or warning) to be transmitted to the analysis set. A set of subjects whose (GCP), and the applicable regulatory
relevant stakeholder by way of the data are to be included in the main requirements. [ICH E6]
local system or another system (usually analyses. This should be defined in the
statistical section of the protocol. NOTE: approval letter. An official
according to an established set of rules). communication from FDA to inform
For example, the system may transmit There are a number of potential analysis
sets, including, for example, the set an applicant of a decision to allow
an alert to a patient’s cardiologist that commercial marketing consistent with
the patient has experienced another based upon the intent-to-treat principle.
[ICH E9] conditions of approval. [Modified from
heart attack. Another example is that 21 CFR 314.3; Guidance to Industry and
the pharmacy system may transmit an analysis variables. Variables used to FDA Staff (10/08/2003)]
alert to the prescribing physician that test the statistical hypotheses identified
a potentially dangerous drug-drug in the protocol and analysis plan; arm. A planned sequence of elements,
interaction may occur based on the variables to be analyzed. [PR Project] See typically equivalent to a treatment
current list of medications. Another also variable. group. [SDTM] See element.
example is that the system may notify
a patient’s physician that laboratory anchor. Designation for a planned assessment. A measurement,
results (that are not within normal limits) activity, often marking the transition evaluation, or judgment for a study
are available. [HL7 EHR-S FM Glossary of between epochs or elements of a clinical variable pertaining to the status of
Terms, 2010] study plan (e.g., “FPFV—first patient a subject. NOTE: Assessments are
first visit”). usually measured at a certain time,
algorithm. Step-by-step procedure and usually are not compounded
for solving a mathematical problem; anonymized. Personal data which significantly by combining several
also used to describe step-by-step have been processed to make it simultaneous measurements to form
12 Applied Clinical TrialS appliedclinicaltrialsonline.com December 2011a derived assessment (e.g., BMI) or audit certificate. Document that back translation (natural
a result of statistical analysis. See certifies that an audit has taken place language). The process of translating
variable; outcome, endpoint; the term (at an investigative site, CRO, or clinical a document that was translated from
assessment is intended to invoke some research department of a pharm one language to another back to the
degree of evaluation or judgment aceutical company). [ICH E6 Glossary] original language. Used to ensure that
concerning subject status. consent forms, surveys, and other
audit report. A written evaluation by clinical trial documents will be clear and
attributable. A quality by which the auditor of the results of the audit. accurate in the translated form.
records and data can be traced back to [Modified from ICH E6 Glossary]
the subject to whom they pertain, as background material. Information
well as to those persons who have acted audit trail. A process that captures pertinent to the understanding of a
on the records. details such as additions, deletions, protocol. NOTE: Examples include
or alterations of information in an investigator brochure, literature review,
attribute (n). In data modeling, refers electronic record without obliterating history, rationale, or other documentation
to specific items of data that can be the original record. An audit trail that places a study in context or presents
collected for a class. facilitates the reconstruction of the critical features. [PR Project]
history of such actions relating to
audit. A systematic and independent balanced study. Trial in which a
the electronic record. [after ICH E6,
examination of trial-related activities particular type of subject is equally
CSUICI]
and documents to determine whether represented in each study group.
the evaluated trial-related activities were authorization. The process of giving
conducted and the data were recorded, someone permission to do or have bandwidth. An indicator of the
analyzed, and accurately reported something. In multi-user computer throughput (speed) of data flow on
according to the protocol, sponsor’s systems, a system administrator defines a transmission path; the width of
standard operating procedures (SOPs), for the system which users are allowed the range of frequencies on which a
good clinical practice (GCP), and the access to the system and what privileges transmission medium carries electronic
applicable regulatory requirement(s). of use are permitted. [HL7 EHR-S FM signals. All digital and analog signal
[ICH E6 Glossary] Glossary of Terms, 2010]. channels have a bandwidth.
December 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 13Special Resource Issue CDisc Clinical Research Glossary
baseline assessment. Assessment of difference exists; a false acceptance blinded (masked) medications.
subjects as they enter a trial and before of the null hypothesis. See also Type 2 Products that appear identical in size,
they receive any treatment. error. [AMA Manual of Style] shape, color, flavor, and other attributes
to make it very difficult for subjects
baseline characteristics. bias. Situation or condition that causes and investigators (or anyone assessing
Demographic, clinical, and other a result to depart from the true value the outcome) to determine which
data collected for each participant at in a consistent direction. Bias refers to medication is being administered.
the beginning of the trial before the defects in study design or measurement.
intervention is administered. NOTE: [AMA Manual of Style. See also ICH E9, blinded study. A study in which the
Randomized, controlled trials aim CONSORT Statement] subject, the investigator, or anyone
to compare groups of participants assessing the outcome is unaware of
that differ only with respect to the bioanalytical assays. Methods for the treatment assignment(s). NOTE:
quantitative measurement of a drug, Blinding is used to reduce the potential
intervention (treatment). Although
drug metabolites, or chemicals in for bias. [Modified ICH E6 Glossary] See
proper random assignment prevents
biological fluids. also blinding/masking, double-blind
selection bias, it does not guarantee
that the groups are equivalent at bioavailability. Rate and extent study, single-blind study, triple-blind
baseline. Any differences in baseline to which a drug is absorbed or is study; contrast with open-label or
characteristics are, however, the otherwise available to the treatment site unblinded study.
result of chance rather than bias. The in the body. blinding. A procedure to limit
study groups should be compared at
bioequivalence. Scientific basis bias by preventing subjects and/
baseline for important demographic
on which drugs with the same active or study personnel from identifying
and clinical characteristics. Baseline
ingredient(s) are compared. NOTE: which treatments or procedures
data may be especially valuable when
To be considered bioequivalent, the are administered, or from learning
the outcome measure can also be
bioavailability of two products must the results of tests and measures
measured at the start of the trial.
not differ significantly when the two undertaken as part of a clinical
[CONSORT Statement]
products are given in studies at the investigation. NOTE: Masking, while
baseline imbalance. Systematic error same dosage under similar conditions. often used synonymously with
in creating intervention groups, such that blinding, usually denotes concealing
they differ with respect to prognosis. biological marker. See biomarker. the specific study intervention used.
That is, the groups differ in measured [from ICH E9] The term masking is
Biologics Licensing Application often preferred to blinding in the
or unmeasured baseline characteristics
(BLA). An application to FDA for field of ophthalmology. [from AMA
because of the way participants were
a license to market a new biologic Manual of Style]. See also blinding,
selected or assigned. NOTE: Also used
product in the United States. double-blind study, masking, single-
to mean that the participants are not
representative of the population of all biomarker. A characteristic that is blind study, triple-blind study.
possible participants. [ICH E9] objectively measured and evaluated Contrast with open-label and/or
as an indicator of normal biological unblinded study.
Bayesian approaches. Approaches
processes, pathogenic processes, branch. Point within a study design
to data analysis that provide a posterior
or pharmacologic responses to a where there is an allocation of subject
probability distribution for some
therapeutic intervention. [Biomarker subsets to particular procedures or
parameter (e.g., treatment effect),
definitions working group] treatment groups.
derived from the observed data and
a prior probability distribution for the biometric signature. A brand name. See proprietary name.
parameter. The posterior distribution signature based on the verification Synonyms: trade name; proprietary
is then used as the basis for statistical of an individual’s identity, based on name. [SPL]
inference. [ICH E9 Glossary] measurement of the individual’s physical
feature(s) or repeatable action(s), browser. Computer program that runs
Bayesian statistics. Statistical where those features and/or actions on the user’s desktop computer and is
approach named for Thomas Bayes are both unique to that individual, and used to navigate the World Wide Web.
(1701–1761) that has among measureable [21 CFR 11] See also web browser.
its features giving a subjective
interpretation to probability, accepting biostatistics. Branch of statistics cache. Storage area on a computer’s
the idea that it is possible to talk applied to the analysis of biological hard drive where the browser stores
about the probability of hypotheses phenomena. (for a limited time) web pages and/or
being true and of parameters having graphic elements.
particular values. blind review. Checking and assessing
data prior to breaking the blind, for carry-over effect. Effects of
beta error. Probability of showing the purpose of finalizing the planned treatment that persist after treatment
no significant difference when a true analysis. [Modified ICH E9] has been stopped, sometimes beyond
14 Applied Clinical TrialS appliedclinicaltrialsonline.com December 2011the time of a medication’s known designed to record all of the protocol- moderate, and mild) into various
biological activity. required information to be reported to categories.
the sponsor for each trial subject. 2.
case history. An adequate and causality assessment. An evaluation
A record of clinical study observations
accurate record prepared and maintained performed by a medical professional
and other information that a study
by an investigator that records all concerning the likelihood that a therapy
protocol designates must be completed
observations and other data pertinent to or product under study caused or
for each subject. NOTE: In common
the investigation on each individual contributed to an adverse event.
usage, CRF can refer to either a CRF
administered the investigational drug
(device or other therapy) or employed as page, which denotes a group of one CDISC SHARE. A global, accessible,
a control in the investigation. NOTE: Case or more data items linked together for electronic library, which, through
histories include the case report forms collection and display, or a casebook, advanced technology, enables precise
and supporting data including, for which includes the entire group of CRF and standardized data element
example, signed and dated consent pages on which a set of clinical study definitions that can be used within
forms and medical records including, for observations and other information applications and across studies to
example, progress notes of the physician, can be or have been collected, or improve biomedical research and its link
the individual’s hospital chart(s), and the the information actually collected by with healthcare. In the first iteration,
nurses’ notes. The case history for each completion of such CRF pages for CDISC SHARE will contain the existing
individual shall document that informed a subject in a clinical study [ICH E6 CDISC standards, such as CDASH and
consent was obtained prior to Glossary]. See also CRF (paper). SDTM, providing machine-readable
participation in the study. [21 CFR elements (variables) within those
312.62b] case report tabulations (CRT). In standards. This will allow a range of
a paper submission, listings of data that applications used within organizations
case record form. See case report may be organized by domain (type of to automatically access those
form. data) or by subject. See also eCRT. definitions. [CDISC]
case report form (CRF). 1. A categorical data. Data evaluated CDISC Standard (The). CDISC term
printed, optical, or electronic document by sorting values (for example, severe, for a proposed uniform CDISC standard
December 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 15Special Resource Issue CDisc Clinical Research Glossary
intended to address the full life-cycle clinical benefit if it prolongs life, clinical pharmacology. Science that
of a clinical trial including protocol improves function, and/or improves the deals with the characteristics, effects,
representation, capture of source data, way a subject feels. properties, reactions, and uses of drugs,
submission, and archiving using a set of particularly their therapeutic value in
fully integrated and consistent models, clinical clarification. A query humans, including their toxicology,
terms, and controlled vocabularies derived resolution received from the sponsor safety, pharmacodynamics, and
from the current set of CDISC standards. staff (medical monitors, DSMB pharmacokinetics (ADME).
monitoring board, etc.). See also self-
certified copy. A copy of original clinical protocol. See protocol.
evident change.
information that has been verified
clinical research and
as indicated by a dated signature, as clinical data. Data pertaining to the
development. The testing of a
an exact copy having all of the same medical well-being or status of a patient
drug compound in humans primarily
attributes and information as the or subject.
done to determine its safety and
original. NOTE: The copy may be verified
clinical development plan. pharmacological effectiveness. Clinical
by dated signature or by a validated
A document that describes the development is done in phases, which
electronic process. A certified copy of a
collection of clinical studies that are progress from very tightly controlled
source document may serve as a source
to be performed in sequence, or dosing of a small number of subjects to
for a clinical investigation. See also
in parallel, with a particular active less tightly controlled studies involving
source data, source. [After CSUICI]
substance, device, procedure, or large numbers of patients. [SQA]
Certified IRB Professional (CIP). treatment strategy, typically with the
clinical research associate
Certification awarded to persons who intention of submitting them as part
(CRA). Person employed by a sponsor
satisfy the educational and employment of an application for a marketing
or by a contract research organization
requirements and pass an examination authorization. NOTE: The plan should
acting on a sponsor’s behalf, who
conducted by the Applied Research have appropriate decision points and
monitors the progress of investigator
Ethics National Association (ARENA), allow modification as knowledge
sites participating in a clinical study.
the membership division of Public accumulates. [from ICH E9] See also
At some sites (primarily in academic
Responsibility in Medicine and Research development plan. settings), clinical research coordinators
(PRIM&R).
clinical document architecture. are called CRAs.
class. A definition of objects with Specification for the structure and clinical research coordinator
properties (attributes, methods, semantics of “clinical documents” for (CRC). Person who handles most
relationships) that all objects in the the purpose of exchange. [HL7; SPL] of the administrative responsibilities
class have in common. [HL7, 2001] In
clinical document. A documentation of a clinical trial on behalf of a site
data modeling, a class defines a set of
of clinical observations and services. investigator, acts as liaison between
objects that share the same attributes,
NOTE: An electronic document should investigative site and sponsor, and
relationships, and semantics. A class
incorporate the following characteristics: reviews all data and records before
is usually an entity that represents a a monitor’s visit. Synonyms: trial
person, place, or thing. persistence, stewardship, potential for
authentication, wholeness, and human coordinator, study coordinator, research
clean database. A set of reviewed readability. [SPL] coordinator, clinical coordinator,
data in which errors have been resolved research nurse, protocol nurse.
to meet QA requirements for error rate clinical efficacy. Power or capacity
to produce a desired effect (i.e., clinical significance. Change in a
and in which measurements and other subject’s clinical condition regarded
values are provided in acceptable units; appropriate pharmacological activity in a
specified indication) in humans. [SQA] as important whether or not due to
database that is ready to be locked. See the test intervention. NOTE: Some
also database lock, clean file. clinical encounter. Contact statistically significant changes (in blood
clean file. When all data cleaning is between subject/patient and healthcare tests, for example) have no clinical
completed and database is ready for practitioner/researcher, during which significance. The criterion or criteria for
quality review and unblinding. an assessment or activity is performed. clinical significance should be stated
Contact may be physical or virtual. in the protocol. The term “clinical
client. A program that makes a service [CDISC] significance” is not advisable unless
request of another program, usually operationally defined.
running on a server, that fulfills the clinical investigation. See clinical
request. Web browsers (such as Firefox trial, clinical study. NOTE: Increased clinical study (trial) report. A
and Microsoft Explorer) are clients that usage of investigation or study in the written description of a study of any
request HTML files from web servers. US rather than “trial,” may reflect therapeutic, prophylactic, or diagnostic
the appearance of the term in FDA agent conducted in human subjects,
clinical benefit. A therapeutic regulations concerning clinical research in which the clinical and statistical
intervention may be said to confer activities. description, presentations, and analysis
16 Applied Clinical TrialS appliedclinicaltrialsonline.com December 2011are fully integrated into a single report. cognitive debriefing. A comparator (product). An
NOTE: For further information, see qualitative research tool used to investigational or marketed product
the ICH Guideline for Structure and determine whether concepts and (i.e., active control), or placebo, used
Content of Clinical Study Reports. [ICH items are understood by patients in as a reference in a clinical trial. [ICH E6
E6 Glossary] the same way that PRO instrument Glossary] See also control.
developers intend. NOTE: Cognitive
clinical study. See clinical trial. Competent Authority (CA).
debriefing interviews involve
The regulatory body charged with
clinical trial. A research investigation incorporating follow-up questions in
monitoring compliance with the national
involving human subjects that is a field test interview to gain better
statutes and regulations of European
designed to answer specific questions understanding of how patients
Member States.
about the safety and efficacy of interpret questions asked of them and
a biomedical intervention (drug, to collect and consider all concepts complete file. File for which all data
treatment, device) or new ways of elicited by an item. [from PRO Draft cleaning is complete and database is
using a known drug, treatment, or Guidance Glossary] ready for quality review and unblinding.
device). [modified from ICH E6 Glossary, cohort. 1. A group of individuals who completion. 1. Subject completion:
Directive 2001/20/EC] Synonym: clinical share a common exposure, experience or the case where a subject ceases active
investigation or study. characteristic. 2. A group of individuals participation in a trial because the
clinical trial data. Data collected in followed-up or traced over time in a subject has, or is presumed to have,
the course of a clinical trial. See also cohort study. [AMA Manual of Style] followed all appropriate conditions of a
clinical trial information. protocol. 2. Study completion: according
cohort study. Study of a group to the study protocol, the point at which
clinical trial exemption (CTX). of individuals, some of whom are all protocol-required activities have been
A scheme that allows sponsors to exposed to a variable of interest, in executed. [Modified EU CTD]
apply for approval for each clinical which subjects are followed over time.
Cohort studies can be prospective or compliance (in relation to trials).
study in turn, submitting supporting
retrospective. [AMA Manual of Style] Adherence to trial-related requirements,
data to the Medicines Control Agency
See also prospective study. good clinical practice (GCP) requirements,
(MCA), which approves or rejects
and the applicable regulatory
the application (generally within 35 combination product. 1. A product requirements. [Modified ICH E6 Glossary]
working days). NOTE: Approval means comprising two or more individual
that the company is exempt from the products. 2. Two or more separate computer application. See
requirement to hold a clinical trial products packaged together in a single application.
certificate (CTC). [UK] package or as a unit. 3. A product that concept. Discrete notion having
clinical trial information. Data is packaged separately but is used only a single meaning. In a controlled
collected in the course of a clinical with another product. [Modified from vocabulary a concept is mapped to one
trial or documentation related to the SPL Glossary] or more of the words that convey its
integrity or administration of that data. common data element. A meaning.
A superset of clinical trial data. structured item characterized by a confidence interval. A measure
clinical trial materials. Complete stem and response options together of the precision of an estimated value.
set of supplies provided to an with a history of usage that can be The interval represents the range of
investigator by the trial sponsor. standardized for research purposes values, consistent with the data, that is
across studies conducted by and for believed to encompass the “true” value
clinician reported outcome. NIH. NOTE: The mark up or tagging with high probability (usually 95%).
Clinician assessment of patient facilitates document indexing, search The confidence interval is expressed in
outcomes, based on objective or and retrieval, and provides standard the same units as the estimate. Wider
subjective data evaluated by the conventions for insertion of codes. [NCI, intervals indicate lower precision;
clinician. CaBIG]. See also item. narrow intervals, greater precision.
[CONSORT Statement]
codelist. Finite list of codes and Common Technical Document. A
their meanings that represent the only format agreed upon by ICH to organize confidentiality. Prevention of
allowed values for a data item. See also applications to regulatory authorities disclosure to other than authorized
controlled vocabulary. A codelist is one for registration of pharmaceuticals for individuals of a sponsor’s proprietary
type of controlled vocabulary. human use. [ICH] See also eCTD. information or of a subject’s identity.
[ICH E6 Glossary]
coding. In clinical trials, the process of comparative study. One in which
assigning data to categories for analysis the investigative drug is compared confirmatory trial. Phase 3 trial
NOTE: Adverse events, for example, may against another product, either active during which the previously revealed
be coded using MedDRA. drug or placebo. actions of a therapeutic intervention
December 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 17Special Resource Issue CDisc Clinical Research Glossary
are confirmed. NOTE: Procedures in contract. A written, dated, and coordinating committee. A
confirmatory trials should be set firmly in signed agreement between two or committee that a sponsor may organize
advance. Compare to exploratory trial. more involved parties that sets out to coordinate the conduct of a
conformity assessment. The any arrangements on delegation and multicenter trial. [ICH E6]
process by which compliance with distribution of tasks and obligations
and, if appropriate, on financial matters. coordinating investigator. An
the EMA’s Essential Requirements is
The protocol may serve as the basis of a investigator assigned the responsibility
assessed. See also Notified Body.
contract. [ICH E6 Glossary] for the coordination of investigators
consent form. Document used during at different centers participating in a
the informed consent process that is the control (of electronic records). multicenter trial. [ICH E6]
basis for explaining to potential subjects To prepare and maintain case histories
the risks and potential benefits of a correlation. The degree to which
and other records for regulated clinical
study and the rights and responsibilities two or more variables are related.
investigations. NOTE: Control is often
of the parties involved. NOTE: The Typically the linear relationship is
used as a casual synonym for the terms
informed consent document provides measured with either Pearson’s
in 21 CFR 312.62 requiring investigative correlation or Spearman’s rho. NOTE:
a summary of a clinical trial (including
sites to prepare, maintain, and retain Correlation does not necessarily mean
its purpose, the treatment procedures
adequate and accurate case histories. causation. [After HyperStat Online
and schedule, potential risks and
benefits, alternatives to participation, Glossary; ADaM]
control group. The group of
etc.) and explains an individual’s rights subjects in a controlled study that covariate (prognostic). Factor or
as a subject. It is designed to begin
receives no treatment, a standard condition that influences outcome of a
the informed consent process, which
treatment, or a placebo. [21 CFR trial. [ADaM]
consists of conversations between the
subject and the research team. If the 314.126] See also controls.
CRF data. Subset of clinical trial data
individual then decides to enter the control(s). 1. Comparator against that are entered into fields on a CRF.
trial, s/he gives her/his official consent which the study treatment is evaluated
by signing the document. Synonym: CRF (paper). Case report form in
[e.g., concurrent (placebo, no treatment, which the data items are linked by
informed consent form; see also
dose-response, active), and external the physical properties of paper to
informed consent.
(historical, published literature)] 2. particular pages. NOTE: Data are
consumer safety officer (CSO). Computer: processes or operations captured manually and any comments,
FDA official who coordinates the review intended to ensure authenticity, notes, and signatures are also linked to
process of various applications. integrity, and confidentiality of electronic those data items by writing or typescript
records. NOTE: The protocol incorporates on the paper pages. See also eCRF, case
content validity. The extent to
scientific rationale for selection of report form.
which a variable (for example, a rating
scale) measures what it is supposed to comparator and describes how the crossover trial. A trial design
measure. [ICH E9 Glossary] Evidence from comparator serves as a reference point for which subjects function as their
qualitative research demonstrating that for the evaluation. SDTM provides a own control and are assigned to
the instrument measures the concept codelist for type of control. [1. After ICH receive investigational product and
of interest, including evidence that the E10. 2. After 21 CFR 11; CSUCT] controls in an order determined
items and domains of an instrument are by randomizations, typically with a
appropriate and comprehensive, relative controlled study. A study in which a washout period between the two
to its intended measurement concept, test article is compared with a treatment products. [Center for the Advancement
population, and use. NOTE: Testing other that has known effects. The control of Clinical Research; ADaM]
measurement properties will not replace group may receive no treatment, active
or rectify problems with content validity. treatment, placebo, or dose comparison curriculum vitae (cv). Document
[FDA Final PRO Guidance] concurrent control. NOTE: For further that outlines a person’s educational and
professional history.
contingent subject trial contact. information on “adequate and well-
Planned response to an anticipated controlled study” see 21 CFR 314.126. data. Representations of facts,
but conditional event in a clinical trial. concepts, or instructions in a
controlled terminology. Synonym
[CDISC Trial Design Project] manner suitable for communication,
for controlled vocabulary. interpretation, or processing by humans
contract research organization or by automated means. [FDA]
(CRO). A person or an organization controlled vocabulary. A finite
(commercial, academic, or other) set of values that represent the only data acquisition. Capture of data
contracted by the sponsor to perform allowed values for a data item. These into a structured, computerized format
one or more of a sponsor’s trial-related values may be codes, text, or numeric. without a human-to-computer interface
duties and functions. [ICH E6 Glossary] See also codelist. (i.e., from another measuring instrument
18 Applied Clinical TrialS appliedclinicaltrialsonline.com December 2011or computerized source). Contrast with of the cipher who know the algorithm data item. A named component of
data entry, electronic data capture. but do not have the correct key cannot a data element. Usually the smallest
derive the original data algorithmically. component [ANSI]. See also data model,
data and safety monitoring NOTE: Data that is considered sensitive data element.
board (DSMB). See data monitoring by the responsible authority or data
committee. data management conventions.
that represents a high value should
Procedures and policies for data man-
data capture. See data entry. be cryptographically protected if it is
agement (e.g., documented procedure(s)
vulnerable to unauthorized disclosure
data clarification. Answer supplied for resolving self-evident changes). [ICH
or undetected modification during
by the investigator in response to a E6] See self-evident change.
transmission or while in storage.
query. NOTE: The investigator may [from Federal Information Processing data management. Tasks associated
supply a new data point value to replace Standards (FIPS) Publication 46-2] with the entry, transfer, and/or
the initial value or a confirmation of the preparation of source data and derived
queried data point. data entry. Human input of data items for entry into a clinical trial
into a structured, computerized format database. NOTE: Data management
data clarification form. A form using an interface such as a keyboard, could include database creation, data
used to query an investigator and pen-based tablet, or voice recognition. entry, review, coding, data editing, data
collect feedback to resolve questions NOTE: Although data capture is QC, locking, or archiving; it typically
regarding data. often used synonymously, capture does not include source data capture.
data collection. In the context implies direct entry of original source
data into an electronic record rather data model. Unambiguous,
of clinical research, accessing
than transcription (entry) from paper formally stated, expression of items,
and recording information that
source. Contrast with data acquisition, the relationship among items, and
provides source data for analysis and
electronic data capture; direct entry. See the structure of the data in a certain
interpretation See data entry and data
data collection. problem area or context of use. A data
capture. [CDISC]
model uses symbolic conventions agreed
data collection instrument. A data integrity. A dimension of to represent content so that content
substrate or tool (either electronic or data contributing to trustworthiness does not lose its intended meaning
paper) used to record, transcribe, or and pertaining to the systems and when communicated.
collect clinical data. [PR Project] processes for data capture, correction,
maintenance, transmission, and data monitoring. Process by
data element. 1. For XML, an item retention. Key elements of data which clinical data are examined for
of data provided in a mark up mode to completeness, consistency, and accuracy.
integrity include security, privacy, access
allow machine processing. 2. Smallest controls, a continuous pedigree from data monitoring committee
unit of information in a transaction. capture to archive, stability (of values, (DMC). Group of individuals with
3. A structured item characterized by of attribution), protection against pertinent expertise that reviews on a
a stem and response options together loss or destruction, ease of review regular basis accumulating data from an
with a history of usage that can be by users responsible for data quality, ongoing clinical trial. The DMC advises
standardized for research purposes proper operation and validation of the sponsor regarding the continuing
across studies conducted by and for NIH. systems, training of users. NOTE: In safety of current participants and those
NOTE: The mark up or tagging facilitates clinical research the FDA requires that yet to be recruited, as well as the
document indexing, search and retrieval, data relied on to determine safety and continuing validity and scientific merit
and provides standard conventions for efficacy of therapeutic interventions be of the trial. NOTE: A DMC can stop a
insertion of codes. [1. FDA - GL/IEEE. trustworthy and establishes guidance trial if it finds toxicities or if treatment is
2. Center for Advancement of Clinical and regulations concerning practices proved beneficial. [After FDA guidance
Research. 3. NCI, caBIG] and system requirements needed to on establishment and operation of
promote an acceptable level of data clinical trial data monitoring committees]
data encryption standard (DES).
A FIPS approved cryptographic algorithm integrity. [FDA, CSUICI, IEEE]. Compare
data quality. A dimension of data
for encrypting (enciphering) and with data quality.
contributing its trustworthiness and
decrypting (deciphering) binary coded data integrity verification. Process pertaining to accuracy, sensitivity, validity,
information. Encrypting data converts it of manually supervised verification of and suitability to purpose. Key elements
to an unintelligible form called cipher. data for internal consistency. of data quality include attribution,
Decrypting cipher converts the data legibility (decipherable, unambiguous),
back to its original form called plaintext. data interchange. Transfer of contemporaneousness, originality (i.e.,
The standard specifies both enciphering information between two or more not duplicated), accuracy, precision,
and deciphering operations, which parties, which maintains the integrity of completeness, consistency (logical, not
are based on a 64 bit binary number the contents of the data for the purpose out of range), and those who have
called a key. Unauthorized recipients intended. See also interoperability. modified the data. NOTE: Scientists may
December 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 19Special Resource Issue CDisc Clinical Research Glossary
reasonably trust data that are accurate data storage. To maintain data by derived variable. New variable
(high quality) that have also been placing the data, or a copy of the data, created as a function of existing
reviewed by investigators and protected onto an electronically accessible device variables and/or application of
from unauthorized alteration (high for preservation (either in plain-text mathematical functions. See also
integrity). See also ALCOA, data integrity. or encrypted format). [HL7 EHR-S FM variable, raw data.
Glossary of Terms, 2010].
data security. Degree to which data design. 1. In the context of clinical
are protected from the risk of accidental decision rule. Succinct statement trials, see design configuration. 2. In
or malicious alteration or destruction of how a decision will be reached the context of eClinical trials systems,
and from unauthorized access or based upon the expected foreseen a design for an application to support
disclosure. [FDA] clinical benefits in terms of outcomes actions on electronic records.
of the primary endpoint. [FDA
data selection criteria. The rules by documentation] design configuration. Clinical
which particular data are selected and/ trial design developed to compare
or transferred between the point of care Declaration of Helsinki. A treatment groups in a clinical trial.
and the patient record; subsequently, set of recommendations or basic NOTE: The configuration usually
from the patient record to the database; principles that guide medical doctors requires randomization to one or
and from database to inclusion in sub- in the conduct of biomedical research more treatment arms, each arm being
population analyses. involving human subjects. It was allocated a different (or no) treatment.
originally adopted by the 18th World Examples include: Parallel Group Design,
data transformations. Algorithmic
Medical Assembly (Helsinki, Finland, Crossover Design, Factorial Designs.
operations on data or data sets to
1964) and recently revised (52nd WMA [from ICH E9]
achieve a meaningful set of derived data
General Assembly, Edinburgh, Scotland,
for analysis. [ADaM] See also derived development plan. An ordered
October 2000).
variable.
program of clinical trials, each with
define.XML. Table used by XML
data type. Data types define the specific objectives. [Adapted from
review tools to configure a review
structural format of the data carried ICH E9, see ICH E8]. See also clinical
engine to deal with CDISC standard
in the attribute and influence the set development plan.
data for a trial.
of allowable values an attribute may
assume. [HL7] de-identified. Removal of elements development process. See drug
connected with data which might development process.
data validation. 1. Checking data
aid in associating those data with an digital signature. An electronic
for correctness and/or compliance
individual. Examples include name, birth signature, based on cryptographic
with applicable standards, rules,
date, social security number, home
and conventions. 2. Process used methods of originator authentication,
address, telephone number, e-mail
to determine if data are inaccurate, computed by using a set of rules and a
address, medical record numbers, health
incomplete, or unreasonable. The set of parameters, such that the identity
plan beneficiary numbers, full-face
process may include format checks, of the signer and the integrity of the
photographic images). See anonymized.
completeness checks, check key tests, data can be verified. [21 CFR 11]
[HIPAA: 45 CFR, 164.514]
reasonableness checks, and limit checks.
[1. FDA. 2. ISO] direct access. Permission to examine,
demographic data. Characteristics
analyze, verify, and reproduce any
of subjects or study populations, which
data listing. Set of observations records and reports that are important
include such information as age, sex,
organized by domain. to evaluation of a clinical trial. NOTE:
family history of the disease or condition
The party (e.g., domestic and foreign
database. A collection of data or for which they are being treated, and
regulatory authorities, sponsor’s
information, typically organized for ease other characteristics relevant to the
monitors and auditors) with direct
and speed of search and retrieval. study in which they are participating.
access should take all reasonable
database lock. Action taken to dependent variable. Outcomes that precautions within the constraints of the
prevent further changes to a clinical are measured in an experiment and that applicable regulatory requirement(s) to
trial database. NOTE: Locking of a are expected to change as a result of maintain the confidentiality of subjects’
database is done after review, query an experimental manipulation of the identities and sponsor’s proprietary
resolution, and a determination has independent variable(s). [Center for information. [ICH E6 Glossary]
been made that the database is ready Advancement of Clinical Research]
direct entry. Recording of data by
for analysis
deployment. Readying an electronic human or automated action where an
dataset. A collection of structured clinical trial system for field use by electronic record is the original means
data in a single file. [CDISC, ODM, and providing or disseminating capture of capturing the data into an electronic
SDS] Compare with analysis dataset, devices, tokens, or passwords for users records system without a paper source
tabulation dataset. of an activated system. See activation. document. Examples are an individual
20 Applied Clinical TrialS appliedclinicaltrialsonline.com December 2011keying original observations into a
system or the automatic recording
into the system of the output from Ethics Committees
measuring devices such as a balance Bodies convened to protect human clinical research subjects
that measures subject’s body weight or work under a variety of other names. For convenience and
an ECG machine. Compare with data consistency, Applied Clinical Trials generally uses the terms
entry, data acquisition.
institutional review board and ethics committee. Other names
discontinuation. The act of and abbreviations for such bodies are shown below.
concluding participation, prior to
CCI committee on clinical investigations
completion of all protocol-required
elements, in a trial by an enrolled CCPPRB Comité Consultative pour la Protection des Personnes dans
subject. NOTE: Four categories of les Recherches Biomédicales (France)
discontinuation are distinguished: a) CHR committee on human research
dropout: Active discontinuation by a CPPHS committee for the protection of human subjects
subject (also a noun referring to such
a discontinued subject); b) investigator CRB central review board
initiated discontinuation (e.g., for EAB ethical advisory board
cause); c) loss to follow-up: cessation of EC ethics committee
participation without notice or action
HEX human experimentation committee
by the subject; d) sponsor initiated
discontinuation. Note that subject HSRC human subjects review committee
discontinuation does not necessarily IEC independent ethics committee
imply exclusion of subject data from IRB independent review board; institutional review board
analysis. “Termination” has a history of
synonymous use, but is now considered LREC local research ethics committees (UK)
nonstandard. See also withdrawal and MREC multicentre research ethics committees (UK)
ICH E3, section 10.1 and FDA Guidance NIRB noninstitutional review board
for Industry: Submission of Abbreviated
NRB noninstitutional review board, also known as an independent
Reports & Synopses in Support of
review board
Marketing Applications, IV A.
REB research ethics board (Canada)
discrepancy. The failure of a data
point to pass a validation check. NOTE:
Discrepancies may be detected by description, and figures. Descriptors documentation. All records, in
computerized edit checks or observed/ for HL7 documents include type, any form (including but not limited
identified by the data reviewer as a class, and element. NOTE: In HL7, to written, electronic, magnetic, and
result of manual data review. See also a document can be either physical optical records, and scans, x-rays, and
query. (referring to the paper) or logical electrocardiograms) that describe or
disease. Any deviation from or (referring to the content) with the record the methods, conduct,
interruption of the normal structure or following characteristics: 1) Steward and/or results of a trial, the factors
function of a part, organ, or system of ship; 2) Potential for authentication; 3) affecting a trial, and the actions taken.
the body as manifested by characteristic Wholeness; 4) Human readability; 5) [ICH E6 Glossary]
symptoms and signs. [Dorland’s Medical Persistence; 6) Global vs. local context.
domain. A collection of observations
Dictionary] with a topic-specific commonality about
document root. The element in
distribution. 1. In statistics, a group an XML document that contains all each subject in a clinical investigation.
of ordered values; the frequencies or other elements; the first element in the NOTE: CDISC classifies domains. For
relative frequencies of all possible val document. [SPL Glossary] example, the Interventions class is a
ues of a characteristic. 2. In pharma domain that captures investigational
document type definition (DTD). treatments, therapeutic treatments, and
cokinetics, the processes that control
XML specification for content and surgical procedures that are intentionally
transfer of a drug from the site of
presentation of data and text in a administered to the subject (usually for
measurement to its target and other
document including definitions for therapeutic purposes) either as specified
tissues. [1. AMA Manual of Style]. See
the elements considered to be legal in by the study protocol (e.g., exposure),
also ADME.
the document. NOTE: Agreeing on a coincident with the study assessment
document (HL7). An ordered common DTD facilitates interoperability period (e.g., concomitant medications),
presentation of XML elements, possibly among systems incorporating the or other substances self-administered by
including text and tabular analyses, agreed standards. [from XML files.com] the subject (such as alcohol, tobacco,
December 2011 appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 21Special Resource Issue CDisc Clinical Research Glossary
or caffeine). The Events class captures investigator nor the research team GCP/454280/2010 GCP Inspectors
occurrences or incidents independent interacting with the subject or data Working Group (GCP IWG) June 2010]
of planned study evaluations occurring during the trial knows what treatment a
during the trial (e.g., “adverse events” subject is receiving. eClinical trial. Clinical trial in which
or “disposition”) or prior to the trial primarily electronic processes are
(e.g., “medical history”). The Findings double-dummy. A technique for used to plan, collect (acquire), access,
class captures the observations resulting retaining the blind when administering exchange, and archive data required for
from planned evaluations such as supplies in a clinical trial, when the two conduct, management, analysis, and
observations made during a physical treatments cannot be made identical. reporting of the trial. NOTE: FDA has
examination, laboratory tests, ECG Supplies are prepared for Treatment A recently drawn a distinction between
testing, and sets of individual questions (active and indistinguishable placebo) studies and trials. Both words refer to
listed on questionnaires. and for Treatment B (active and systematic efforts to obtain evidence
indistinguishable placebo). Subjects then relevant to regulatory authorities,
domain name. The way a particular take two sets of treatment; either A but, depending on regulatory
web server is identified on the Internet. (active) and B (placebo), or A (placebo) context and particularly in the case
For example, www.fda.gov names the and B (active). [ICH E9] of postmarketing commitments, a
World Wide Web (www) server for the study might not be the appropriate
Food and Drug Administration, which is dropout. A subject in a clinical trial word for a clinical trial (prospective,
a government (.gov) entity. [Center for who for any reason fails to continue in controlled, randomized), but should
Advancement of Clinical Research] the trial until the last visit or observation be reserved instead for surveillance,
required of him/her by the study structured gathering of information,
dosage. The amount of drug protocol. [from ICH E9] epidemiological studies, or even animal
administered to a patient or test subject studies [DRAFT Guidance for Industry
over the course of the clinical study; a drug. 1. Article other than food
intended for use in the diagnosis, cure, Postmarketing Studies and Clinical
regulated administration of individual Trials—Implementation of Section
doses. [AMA Manual of Style] mitigation, treatment, or prevention
of disease; or intended to affect the 505(o) of the Federal Food, Drug, and
dosage form. Physical characteristics structure or any function of the body. Cosmetic Act]. Synonyms: eClinical
of a drug product, (e.g., tablet, Not a device or a component, part, study, eClinical investigation.
capsule, or solution) that contains a or accessory of a device. 2. Substance eCRF. 1. Auditable electronic record
drug substance, generally—but not recognized by an official pharmacopia designed to capture information
necessarily—in association with one or formulary. [from FDA Glossary of required by the clinical trial protocol
or more other ingredients. [21 CFR Terms, CDER] to be reported to the sponsor on
§314.3]. See also drug product each trial subject. 2. A CRF in which
drug development process.
dosage regimen. The number of The program for advancing an related data items and their associated
doses per given time period; the elapsed investigational product from preclinical comments, notes, and signatures are
time between doses (for example, every studies through approval for marketing linked electronically. NOTE: eCRFs
six hours) or the time that the doses following review by regulatory agencies. may include special display elements,
are to be given (for example, at 8 a.m. electronic edit checks, and other special
drug product. 1. A dosage form that properties or functions and are used for
and 4 p.m. daily); and/or the amount
contains an active drug ingredient or both capture and display of the linked
of a medicine (the number of capsules,
placebo. 2. A finished dosage form as data. [FDA CSUCT]
for example) to be given at each
specific dosing time. [from Center for described in regulations. [SPL Glossary]
eCRT. CRTs provided in electronic
Advancement of Clinical Research] dynamic HTML. Collective term for a format for eSubmissions (electronic
combination of tags and options, style regulatory submissions). NOTE:
dosage strength. 1. Proportion of
sheets, and programming that allows According to FDA guidance, eCRTs are
active substance to excipient, measured
users to create web pages in Hypertext datasets provided as SAS Transport files
in units of volume or concentration.
Mark-up Language (HTML) that are with accompanying documentation
2. The strength of a drug product tells
more responsive to user interaction than in electronic submissions. They enable
how much of the active ingredient
previous versions of HTML. reviewers to analyze each dataset for
is present in each dosage. [2. FDA
each study. Each CRF domain should
Glossary of Terms] eCertified copy. A copy of an be provided as a single dataset;
dose. The amount of drug electronic record that is created however, additional datasets suitable
administered to a patient or test through the application of a process for reproducing and confirming
subject at one time or the total quantity validated to preserve the data and analyses may also be needed. Becoming
administered. [AMA Manual of Style] metadata of the original and where the obsolete, being replaced by SDTM.
validation of the process is certified by
double-blind study. A study in the dated signature of an authorized edit check. An auditable process,
which neither the subject nor the person. [CDISC, after EMA/INS/ usually automated, of assessing the
22 Applied Clinical TrialS appliedclinicaltrialsonline.com December 2011You can also read
