Glossary
The Good Clinical Data Management Practices adopt the ICH definitions for terms defined within the ICH guidelines. Unless otherwise noted, these definitions were taken from ICH E6.1 (ASQ) in a definition indicates the American Society for Quality as a source.
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A
access control
Policy and procedure that defines accessibility to a physical space
or electronic source of information. The policy usually includes the
concept of audit trails, either paper (e.g., signature log) or
electronic.
adverse drug reaction (ADR)
In the pre-approval clinical experience with a new medicinal product
or with its new usage (particularly as the therapeutic dose[s] may
not be established), all noxious and unintended responses to a
medicinal product related to any dose should be considered adverse
drug reactions. The phrase “responses to a medicinal product” means
that a causal relationship between a medicinal product and an
adverse event is at least a reasonable possibility (i.e., the
relationship cannot be ruled out). Regarding marketed medicinal
products, and ADR is a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of diseases or for modification
of physiological function (see ICH Guideline for Clinical Safety
Data Management: Definitions and Standards for Expedited Reporting2).
adverse event (AE)
In a subject or clinical-investigation subject administered a
pharmaceutical product, any untoward medical occurrence which does
not necessarily have a causal relationship with the treatment. An
adverse event (AE) can therefore be any unfavorable and 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 (see the ICH Guideline for Clinical Safety Data Management:
Definitions and Standards for Expedited Reporting).
amendment (to the protocol)
See protocol amendment.
analysis dataset
The final data set, including derived items and excluding redundant
data points, which is used to perform the analyses required for
safety assessment, efficacy assessment, submission to regulatory
authorities, or other review. Can be comprised of one or more data
files.
analysis file
Same as analysis dataset in the context of the GCDMP.
annotated crf
A document that maps the names of the collected items to their
corresponding database tables, variable item names, forms, visits
and any other objects needed for a person to correctly analyze data
collected in a clinical trial. Annotated collection documents are
required so that any person can understand where variables for
analysis originate.
applicable regulatory requirement(s)
Any law(s) and regulation(s) addressing the conduct of clinical
trials of investigational products.
Application Service provider (ASP)
An application service provider is a vendor who provides, manages
and distributes software-based services to customers over a network.
approval (in relation to institutional review boards)
The affirmative decision of the institutional review board (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.
audit
A systematic and independent examination of trial-related activities
and documents to determine whether the trial-related activities
being evaluated were conducted and the data were recorded, analyzed
and accurately reported according to the protocol, the sponsor’s
standard operating procedures (SOPs), GCP, and the applicable
regulatory requirement(s).
audit certificate
A declaration of confirmation by the auditor that an audit has taken
place.
audit report
A written evaluation by the sponsor’s auditor of the results of the
audit.
audit trail
Documentation that allows reconstruction of the course of events.
B
batch job
A series of processes run in an electronic system that perform
specific tasks, such as data validation, query generation, external
data upload, or lab reference range normalization.
biologics
A biological product (as a vaccine or blood serum) used in medicine.
blinding/masking
A procedure in which one or more parties to the trial is kept
unaware of the treatment assignment(s). Single-blinding usually
refers to the subject(s) being unaware, and double-blinding usually
refers to the subject(s), investigator(s), monitor, and, in some
cases, data analyst(s) being unaware of the treatment assignment(s).
C
case report form (CRF)
A printed, optical, or electronic document designed to record all of
the protocol-required information to be reported to the sponsor on each
trial subject.
CDISC
Acronym for the Clinical Data Interchange Standards Consortium.
central lab
A vendor contracted for a clinical trial that processes samples
collected from subjects and provides the results of laboratory tests
or other medical analyses (e.g., ECG results, pathology results) to
the sponsor. Refer to the Laboratory Data Handling chapter.
change control
A procedure that defines how planned changes to any part of a
computer system are handled in a manner as to maintain compliance
with required functionality of that system. The procedure ensures
that changes applied to the system do not unexpectedly impact the
functionality of the system in question, or any other computer
systems. The procedure should also define how unexpected changes to
a system are prevented and managed.
checklist
(ASQ) A tool used to ensure that all important steps or actions in
an operation have been taken. Checklists contain items that are
important or relevant to an issue or situation. Checklists are often
confused with check sheets and data sheets.
CLIA
See Clinical Laboratory Improvement Amendments.
Clinical Laboratory Improvement Amendments (CLIA)
Congress passed the Clinical Laboratory Improvement Amendments
(CLIA) in 1988 establishing quality standards for all laboratory
testing to ensure the accuracy, reliability and timeliness of
patient test results regardless of where the test was performed. See
www.fda.gov/medicaldevices/deviceregulationandguidance/
for more information.
clinical trial/study
Any investigation using human subjects that is intended to discover
or verify the clinical, pharmacological, and/or other
pharmacodynamic effects of an investigational product(s); and/or to
identify any adverse reactions to an investigational product(s);
and/or to study absorption, distribution, metabolism, and excretion
of an investigational product(s) for the purpose of ascertaining its
safety and/or efficacy. The terms “clinical trial” and “clinical
study” are synonymous.
clinical trial/study report
A written description of a trial/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 (see the ICH
Guideline for Structure and Content of Clinical Study Reports).
code libraries
A repository of validated programming logic that can be used during
the programming of edit checks or other programs used in the
collection, review, or analysis of clinical trial data.
common causes
(ASQ) Causes of variation that are inherent in a process over time.
They affect every outcome of the process and everyone working in the
process. See also special causes.
comparator (product)
An investigational or marketed product (i.e., active control) or
placebo used as a reference in a clinical trial.
compliance (in relation to trials)
Adherence to all the trial-related requirements, GCP requirements,
and the applicable regulatory requirements.
composite endpoint
Overall outcome that the protocol is designed to evaluate based on
more than one common endpoint such as myocardial infarction plus
repeat intervention.
compound
A chemical molecule with potential pharmacological activity.
confidentiality
Prevention of disclosure of a sponsor’s proprietary information or
of a subject’s identity to unauthorized individuals.
conformance
(ASQ) An affirmative indication or judgment that a product or
service has met the requirements of a relevant specification, contract, or
regulation.
contract
A written, dated, and signed agreement that sets out any
arrangements on delegation and distribution of tasks and obligations
and, if appropriate, on financial matters between two or more
involved parties. The protocol may serve as the basis of a contract.
coordinating committee
A committee that a sponsor may organize to coordinate the conduct of
a multi-center trial.
coordinating investigator
An investigator assigned responsibility for the coordination of
investigators at different centers that are participating in a
multi-center trial.
contract research organization (CRO)
A person or an organization (e.g., commercial, academic, or
otherwise) contracted by the sponsor to perform one or more of a
sponsor’s trial-related duties and functions.
control chart
(ASQ) A chart with upper and lower control limits on which values of
some statistical measure for a series of samples or subgroups are
plotted. The chart frequently shows a central line to help detect a
trend of plotted values toward either control limit.
corrective action (CA)
(ASQ) The implementation of solutions that lead to the reduction or
elimination of an identified problem.
CS
Clinically Significant.
D
data cleaning
The process of collecting, reviewing, and confirming modifications
to clinical data in such a way that data provided for statistical
analysis is complete, accurate, and consistent with other data
points.
data module
A category of a type of data, such as CRF.
database backup
A duplicate copy of all electronic data and metadata that can be
retrieved in the event of system failure or data corruption.
database lock
The closing of a database after all clinical trial data has been
reviewed, queries resolved and issues addressed, such that the
database cannot be altered in any way.
development/test environment
Computer system instances that are used for study build and test,
prior to release to the production instance. Defined quality
procedures and documentation allow transition of programming code
from one instance to another.
device
I. A means of data collection such as a paper CRF, Personal Digital
Assistant, or medical instrumentation. II. An instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other
similar or related article, including a component part, or accessory
which is: recognized in the official National Formulary, or the
United States Pharmacopoeia, or any supplement to them, intended for
use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other
animals, or intended to affect the structure or any function of the
body of man or other animals, and which does not achieve any of its
primary intended purposes through chemical action within or on the
body of man or other animals and which is not dependent upon being
metabolized for the achievement of any of its primary intended
purposes.
direct access
Permission to examine, analyze, verify, and reproduce any records
and reports that are important to evaluation of a clinical trial.
Any party (e.g., domestic and foreign regulatory authorities,
sponsor’s monitors and auditors) with direct access should take all
reasonable precautions within the constraints of the applicable
regulatory requirement(s) to maintain the confidentiality of
subjects’ identities and sponsor’s proprietary information.
disaster recovery plan
A disaster recovery plan is a comprehensive statement of consistent
actions to be taken before, during and after a disaster. The plan
should be documented and tested to ensure the continuity of
operations and availability of critical resources in the event of a
disaster.
(www.drj.com)
discrepancy
Inconsistency in two or more data points collected in a clinical
trial that must be addressed prior to database lock.
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, or
results of a trial; the factors affecting a trial; and the actions
taken.
double data entry
The process of purposely entering clinical trial data twice for
studies with paper collection media. The two entries are done
independently. The goal is to ensure entry into the electronic
system is completed without transcription errors.
E
e-CRF
Acronym for electronic case report form. An auditable electronic
record designed to record information to be reported to the sponsor
on each trial subject, as required by the clinical trial protocol.
See also case report form.
edits - hard and soft edit
Programmed or manual verifications performed on a clinical database
for the purpose of ensuring a quality final analysis set for
analysis. Hard edits refer to verifications that require a data
change or entry in order to resolve it while Soft edits also accept
a confirmation of the existing data.
EHR
Electronic Health Record.
electronic record
Electronic record means any combination of text, graphics, data,
audio, pictorial, or other information representation in digital
form that is created, modified, maintained, archived, retrieved, or
distributed by a computer system.
electronic signature
Electronic signature means 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.
electronic submission
The set of required documents for a submission, rendered in an
acceptable electronic format that is transmitted to a regulatory
agency in lieu of paper documents for review and approval.
EMR
Electronic Medical Record.
endpoint
Overall outcome that the protocol is designed to evaluate. Common
endpoints are severe toxicity, disease progression, or death.
essential documents
Documents which individually and collectively permit evaluation of
the conduct of a study and the quality of the data produced (see ICH
E6, Section 8. “Essential Documents for the Conduct of a Clinical
Trial”).
EU
European Union.
exposure
The condition of being subject to some effect or influence; in
context of a clinical trial this generally refers to exposure to the test
article/drug.
external data
Data that are collected externally and merged in the CDMS or
analyzed together with data collected on the e/CRF.
F
false negative
A test result that is erroneously classified in a negative category
(as of diagnosis) because of imperfect testing methods or
procedures. In statistics a Type II error.
false positive
A test result that shows evidence of a result or condition although
it is not actually present. In statistics, a Type I error.
field
A particular area (as of a record in a database) in which the same
type of information is regularly recorded.
flag
A tag placed on a data point that defines a status (e.g.,
discrepant, closed, or other status) that indicates an action is
required.
flow diagram, flow chart
A graphic means for depicting the steps or activities that
constitute a process. The flow diagram (flow chart) is constructed
from standard symbols (the delay and database symbols have been
added to Juran’s list4).
The activity symbol is a rectangle that designates an activity.
Within the rectangle is a brief description of that activity.
The decision symbol is a diamond that designates a decision
point from which the process branches into two or more paths.
The path taken depends on the answer to the question that
appears within the diamond. Each path is labeled to correspond
to an answer to the question.
The terminal symbol is a rounded rectangle that unambiguously
identifies the beginning or end of a process. “Start” or “begin”
is used to designate the starting point of a process flow.
“Stop” or “end” is used to designate the end of process flow.
The document symbol is a document pertinent to the process.
The flow line represents a process path that connects process elements. The arrowhead indicates the direction of the flow.
The connector is a circle that is used to indicate a
continuation of the flow diagram.
The delay symbol is a rectangle rounded on one side that
identifies a waiting point or delay in the process flow.
The database symbol is a cylinder that represents a database
application and the contained data.
frozen
A temporary locked state for data that allows the generation of
queries but does not allow a change to data points.
G
global library
In a Clinical Data Management System, the superset of all
standard objects (e.g., CRF modules, edit checks, fields, etc.).
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.
H
hard coding
Computer programs utilize logic and hardware to allow dynamic
responses based on user input. For example, Web site can be
programmed to tabulate the total bill when books are selected
for purchase on-line or the average weight of the patients in
the active treatment arm each time a program is run on a
dataset. “Hard coding” is the limiting of the dynamic response
by actually typing the data in the computer program itself
rather than letting the data come from a dataset or the user.
This approach can be dangerous because it is not visible in the
analysis tables and listings or to the regulatory authorities
and because it is easily forgotten once typed into the computer
program.
hard lock
The final state of the database where no changes are permitted
and all user access is removed.
I
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.
in-control process
(ASQ) A process in which the statistical measure being evaluated
is in a state of statistical control (i.e., the variations among
the observed sampling results can be attributed to a constant
system of chance causes). See also out-of-control process.
independent data-monitoring committee (IDMC) (data and safety
monitoring board, monitoring committee, data monitoring
committee)
An independent data-monitoring committee that may be established
by the sponsor to assess at intervals the progress of a clinical
trial, the safety data, and the critical efficacy endpoints.
Such a committee may also recommend to the sponsor whether to
continue, modify, or stop a trial.
independent ethics committee (IEC)
An independent body—i.e., a review board or a committee, whether
institutional, regional, national, or supranational, constituted
of medical professionals and non-medical members—that is
responsible for ensuring the protection of the rights, safety,
and well-being of human subjects involved in a trial and to
provide public assurance of that protection. These
responsibilities are accomplished 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. The legal
status, composition, function, operations, and regulatory
requirements pertaining to IECs may differ among countries but
should allow the IEC to act in agreement with GCP, as described
in this guideline.
informed consent
A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial after having
been informed of all aspects of the trial that are relevant to
the subject’s decision to participate. Informed consent is
documented by means of a written, signed, and dated
informed-consent form.
inspection
1. (ICH) The act by a regulatory authority (or authorities) of
conducting an official review of documents, facilities, records,
and any other resources that are deemed by the authority 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. 2. (ASQ)
Measuring, examining, testing, and gauging one or more
characteristics of a product or service and comparing the
results with specified requirements to determine whether
conformity is achieved for each characteristic.
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—that is responsible for ensuring 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
amendments and of the methods and material to be used in
obtaining and documenting informed consent of the trial
subjects.
instrument
A device for capturing or measuring the present value of a
quantity under observation.
interim clinical trial/study report
A report of intermediate results and their evaluation based on
analyses performed during the course of a trial.
intervention
A method of interfering with the outcome or course, especially
of a condition or process.
Investigational New Drug application (IND)
An IND application is submitted to the FDA when a sponsor or
investigator wishes to initiate trials with human subjects. The
IND regulations can be found at the following link:
https:// www.fda.gov/cber/ind/ind.htm
. “ND” is synonymous with “Notice of Claimed Investigational
Exemption for a New Drug.”
investigational product
A pharmaceutical form of an active ingredient or placebo that is
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, for an unapproved indication, or to gain further
information about an approved use.
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. See also
subinvestigator.
investigator/institution
An expression meaning “the investigator and/or institution,
where required by the applicable regulatory requirements.”
investigator meeting
The kickoff meeting for an upcoming trial where the
participating investigators review and provide feedback on the
protocol or procedures in a protocol. Training of the principal
investigator or other site staff on protocol procedures and/or
EDC system entry is conducted at the investigator meeting as
well.
investigator’s brochure
A compilation of the clinical and non-clinical data on the
investigational product(s) that is relevant to the study of the
investigational product(s) in human subjects (see ICH E6,
Section 7. “Investigator’s Brochure”).
IOM
Institute of Medicine.
ISE
Integrated Summary of Efficacy.
ISO
(ASQ) English acronym for International Organization for
Standardization.
ISO 9000 series standards
(ASQ) A set of five individual, but related, international
standards on quality management and quality assurance developed
to help companies effectively document the elements that should
be implemented to maintain an efficient quality system.
Initially published in 1987, the standards are not specific to
any particular industry, product, or service. The standards were
developed by the International Organization for Standardization
(ISO), a specialized international agency for standardization
that is composed of the national standards bodies of 91
countries.
ISS
Integrated Summary of Safety.
L
legacy system
An electronic system previously in production, but no longer
actively used, that may contain data needed for current analysis
or other use and therefore must be maintained by the sponsor
organization.
legally acceptable representative
An individual, juridical, or other type of body that is
authorized under applicable law to consent, on behalf of a
prospective subject, to the subject’s participation in the
clinical trial.
local lab
Local labs are labs in close proximity to individual clinical
study sites or patients and are most often used when timely
results are needed.
M
MedDRA
Medical Dictionary for Regulatory Activities is a medical
terminology used to classify adverse event information
associated with the use of biopharmaceuticals and other medical
products. See
www.meddra.org
for additional information.
medical monitor
An individual, other than the principle investigator, who
evaluates clinical trial data from a safety perspective.
medical monitoring
The act of evaluating the clinical trial data from a safety
perspective.
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 to the sponsor that is produced by the monitor
after each site visit and/or other trial-related communication,
as specified by the sponsor’s SOPs.
multi-center trial
A clinical trial that is conducted according to a single
protocol but at more than one site and therefore is carried out
by more than one investigator.
N
NCS
Non Clinically Significant.
new drug application (NDA)
The documentation submitted to the U.S. Food and Drug
Administration. As described by the FDA: The goals of the NDA are to provide enough information to permit
FDA reviewer to reach the following key decisions: Whether the
drug is safe and effective in its proposed use(s), and whether
the benefits of the drug outweigh the risks. Whether the drug’s
proposed labeling (package insert) is appropriate, and what it
should contain. Whether the methods used in manufacturing the
drug and the controls used to maintain the drug’s quality are
adequate to preserve the drug’s identity, strength, quality, and
purity. The documentation required in an NDA is supposed to tell
the drug's whole story, including what happened during the
clinical tests, what the ingredients of the drug are, the
results of the animal studies, how the drug behaves in the body,
and how it is manufactured, processed and packaged.5 The NDA
regulations are 21 CFR 314.
non-clinical study
Biomedical studies that are not performed on human subjects.
O
OCR
Optical Character Recognition.
open access
See National Cancer Institute’s cancer Biomedical Informatics
Grid (caBIG®) for additional details.
open development
See National Cancer Institute’s cancer Biomedical Informatics
Grid (caBIG®) for additional details.
open source
See National Cancer Institute’s cancer Biomedical Informatics
Grid (caBIG®) for additional details.
opinion (in relation to an independent ethics committee)
The judgment and/or the advice provided by an independent ethics
committee (IEC). See also independent ethics committee.
out-of-control process
(ASQ) A process in which the statistical measure being evaluated
is not in a state of statistical control (i.e., the variations
among the observed sampling results can be attributed to a
constant system of chance causes). See also in-control process.
original medical record
See source documents.
P
Pareto Principle / 80-20 rule
An observation that 20% of the input creates 80% of the result
phase I - IV
Refer to the FDA glossary
(clinicaltrials.gov).
predicate rule
The overreaching regulations that the industry must follow for
GxP (Good “Anything” Practice or any collection of quality
guidelines).
production environment
The location (e.g., website, server, EDC) where real clinical
data is entered and stored.
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 details could be provided in other
protocol-referenced documents. Throughout the ICH GCP Guideline,
the term “protocol” refers to protocol and protocol amendments.
protocol amendment
A written description of a change (or changes) to, or formal
clarification of, a protocol.
protocol deviation
Any alteration/modification to the IRB-approved protocol. The
protocol includes the detailed protocol, protocol summary,
consent form, recruitment materials, questionnaires, and any
other information relating to the research study. (Partners
Human Research Committee;
http://healthcare.partners.org)
protocol violation
Any protocol deviation that is not approved by the IRB prior to
its initiation or implementation. (Partners Human Research
Committee;
http://healthcare.partners.org
)
Q
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 with 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 assurance/quality control
(ASQ) Two terms with many interpretations because of the
multiple definitions for the words “assurance” and “control.”
For example, “assurance” can mean the act of giving confidence,
the state of being certain, or the act of making certain.
“Control” can mean an evaluation to indicate needed corrective
responses, the act of guiding, or the state of a process in
which the variability is attributable to a constant system of
chance causes (for a detailed discussion on the multiple
definitions, see ANSI/ISO/aSQC a35342, Statistics—Vocabulary and
Symbols—Statistical Quality Control). One definition of quality
assurance includes the following: all the planned and systematic
activities implemented within the quality system that can be
demonstrated to provide confidence that a product or service
will fulfill requirements for quality. One definition for
quality control includes the following: the operational
techniques and activities used to fulfill requirements for
quality. Often, however, “quality assurance” and “quality
control” are used interchangeably to discuss the actions that
ensure the quality of a product, service, or process.
quality audit
(ASQ) A systematic, independent examination and review to
determine whether quality activities and related results comply
with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve the
objectives.
query rule
See edit check.
R
random sampling
(ASQ) A commonly used sampling technique in which sample units
are selected in such a manner that all combinations of n units
under consideration have an equal chance of being selected as
the sample.
randomization
The process of assigning trial subjects to treatment or control
groups using an element of chance to determine the assignments.
Used to reduce bias.
regulatory authorities
Bodies having the power to regulate. In the ICH GCP Guideline,
the expression “regulatory authorities” includes the authorities
that review submitted clinical data and the authorities that
conduct inspections (see Section 1.291). These bodies are
sometimes referred to as “competent authorities.”
research misconduct
Falsification of data in proposing, designing, performing,
recording, supervising, or reviewing research or in reporting
research results. Falsification includes acts of omission and
commission. Deliberate noncompliance with the regulations can be
considered misconduct but is secondary to falsification of data.
Research misconduct does not include honest error or differences
of opinion.
S
safety database
A database typically used by Drug Safety or Pharmacovigilence
departments to collect adverse event data.
SAS transport file
A machine-independent file that allows you to move a SAS data
set from one operation system to another. (
http://kb.iu.edu/data/aevb.html)
serious adverse event (SAE); serious adverse drug reaction
(serious ADR)
Any untoward medical occurrence that at any dose:
- Results in death;
- Is life-threatening;
- Requires hospitalization or prolongs hospitalization of a subject;
- Results in persistent or significant disability/incapacity; or
- Is a congenital anomaly/birth defect.
Service Level Agreement (SLA) - from the Vendor chapter
An SLA is part of a service contract where the level of
service is formally defined.
SLA
Service Level Agreement.
source data
All information that is necessary for the reconstruction and
evaluation of the trial, including information about clinical
findings, observations, or other activities in a clinical trial.
Source data are contained in source documents such as original
records or certified copies of original records.
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 medico-technical
departments involved in the clinical trial).
special causes
(ASQ) Causes of variation that arise because of special
circumstances. These causes are not an inherent part of a
process. Special causes are also referred to as assignable
causes. See also common causes.
specification
(ASQ) A document that states the requirements to which a given
product or service must conform.
sponsor
An individual, company, institution, or organization that takes
responsibility for the initiation, management, and/or financing
of a clinical trial.
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. The term does not include any person other
than an individual (e.g., it does not include a corporation or
an agency). A sponsor-investigator must fulfill the obligations
of both a sponsor and an investigator.
standard operating procedures (SOPs)
Detailed instructions written to achieve uniformity of the
performance of a specific function.
statistical process control (SPC)
(ASQ) The application of statistical techniques to control a
process. Often the term “statistical quality control” is used
interchangeably with “statistical process control.”
statistical quality control (SQC)
(ASQ) The application of statistical techniques to control
quality. Often the term “statistical process control” is used
interchangeably with “statistical quality control,” although
statistical quality control includes acceptance sampling as well
as statistical process control.
sub-investigator
Any individual member of the clinical trial team designated and
supervised by the investigator at a trial site to perform
critical trial-related procedures and/or to make important
trial-related decisions (e.g., associates, residents, research
fellows). See also investigator.
subject/trial subject
An individual who participates in a clinical trial, either as a
recipient of the investigational product(s) or as a control.
subject identification code
A unique identifier assigned by the investigator to each trial
subject to protect the subject’s identity and to be used in lieu
of the subject’s name when the investigator reports adverse
events and/or other trial related data.
T
trial site
The location(s) where trial-related activities are actually
conducted.
trigger
An event that precipitates other events.
Type I error
(ASQ) An incorrect decision to reject something that is
acceptable, such as a statistical hypothesis or a lot of
products.
Type II error
(ASQ) An incorrect decision to accept something that is
unacceptable.
U
UAT
User Acceptance Testing.
unexpected adverse drug reaction
An adverse reaction, the nature or severity of which is not
consistent with the applicable product information (e.g.,
investigator’s brochure for an unapproved investigational
product or package insert/summary of product characteristics for
an approved product). See the ICH Guideline for Clinical Safety
Data Management: Definitions and Standards for Expedited
Reporting.
V
variable
See also field.
VCL
Virtual Central Lab
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 subjects with incurable diseases, persons in nursing
homes, unemployed or impoverished persons, subjects in emergency
situations, ethnic minority groups, homeless persons, nomads,
refugees, minors, and those incapable of giving consent.
W
well-being (of the trial subjects)
The physical and mental integrity of the subjects participating
in a clinical trial.
WHOdrug
WHO Drug is a dictionary of medicinal product information. It is
used to identify drug names and provides information about a
drug's active ingredients and its therapeutic use(s).
X
XML
Extensible Markup Language is a markup language that defines a
set of rules for encoding documents in a format that is both
human-readable and machine-readable.
References
- International Conference on Harmonisation. Guideline for Good Clinical Practice, E6. Geneva, Switzerland: Author; 1996.
- International Conference on Harmonisation. Guideline for Good Clinical Practice, E2. Geneva, Switzerland: Author; 1996.
- International Conference on Harmonisation. Guideline for Good Clinical Practice, E3. Geneva, Switzerland: Author; 1996.
- Juran JM. Juran’s Quality Control Handbook, 4th ed. New York, NY: McGraw-Hill; 1988.
- US Food and Drug Administration. New Drug Application (NDA) Process Web site. Available at: http://www.fda.gov/cder/regulatory/applications/nda.htm . Accessed on February 27, 2007.
- American Society for Quality. ANSI/ISO/ASQC A3534-2-1993: Statistics—Vocabulary and Symbols—Statistical Quality Control. Milwaukee, WI: American National Standards Institute; 1993.
- Woolen S. Office for Good Clinical Practice Web site. October 2001. Available at: http://www.fda.gov/oc/gcp/ . Accessed on February 27, 2007.
Revision history
Publication Date | Comments |
September 2000 | Initial publication. |
May 2007 | Revised for style, grammar, and clarity. Substance of chapter content unchanged. |
October 2013 | Revised with the addition of approximately seventy-five (75) terms. |