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Glossary- Clinical Trials Terminology – M to P
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Glossary- Clinical Trials Terminology – M to P
M
meta-analysis A statistical process for pooling data from many clinical trials and summarizing it through formal statistical means. Also called overview.
monitor Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol. A monitor’s duties may include, but are not limited to, helping to plan and initiate a trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial.
monitoring report A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs
multicenter trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.
N
n-of-1 study A trial in an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment’s effect in that person, often with experimental and control treatments randomized.
New Drug Application (NDA) An application to FDA for a license to market a new drug in the United States
null hypothesis A null hypothesis (for example, “subjects will experience no change in blood pressure as a result of
administration of the test product”) is used to rule out every possibility except the one the researcher is trying to prove, an assumption about a research population that may or may not be rejected as a result of testing. Used because most statistical methods are less able to prove something true than to provide strong evidence that it
is false
O
open label study A trial in which subjects and investigators know which product each subject is receiving; opposite of doubleblind study.
P
p value The lowest level of significance at which a given null hypothesis can be rejected; that is, the probability of
observing a result as extreme or more extreme than that observed if the null hypothesis is true.
parallel trial Volunteers are randomized to one of two differing treatment groups (usually medicine and placebo) and usually receive the assigned treatment during the entire trial. Also called parallel group trial, parallel design trial.
pharmacodynamics (PD) The branch of pharmacology that studies reactions between drugs and living structures, including the processes of bodily responses to pharmacological, biochemical, physiological, and therapeutic effects.
pharmacokinetics (PK) The study of the processes of bodily absorption, distribution, metabolism, and excretion
(ADME) of compounds and medicines
placebo A pharmaceutical preparation that contains no active agent. In blinded studies, it is generally made to look just like the active product.
postmarketing surveillance Ongoing safety monitoring of marketed drugs.
preclinical studies Animal studies that support Phase 1 safety and tolerance studies and must comply with good
laboratory practice (GLP). Data about a drug’s activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies or trials). Because many animals have much shorter life spans than humans, preclinical studies can provide valuable information about a drug’s possible toxic
effects over an animal’s life cycle and on its offspring.
protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term “protocol” refers to protocol and protocol amendments.
protocol amendment A written description of a change(s) to or formal clarification of a protocol. (ICH)
Glossary- Clinical Trials Terminology – G to L
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Glossary- Clinical Trials Terminology – G to L
G
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
Healthy Volunteer A healthy person who agrees to participate in a clinical trial for reasons other than medical and receives no direct health benefit from participating
Human Subject A human subject, defined in 21 CFR 50.3, is an “individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.”
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
Inclusion Criteria The criteria that prospective subjects must meet to be eligible for participation in a study
Independent Data-Monitoring Committee (IDMC) A 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, and to recommend to the sponsor whether to continue, modify, or stop a trial.
independent ethics committee (IEC) An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved
in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the
methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries, but should allow the independent ethics committee to act in agreement with
GCP as described in the [ICH] 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. (ICH)
Under 21 CFR 50.20, no informed consent may include any “language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”
inspection The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or
at other establishments deemed appropriate by the regulatory authority(ies). (ICH)
Investigational product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when
used to gain further information about an approved use. (ICH)
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. (ICH). 21 CFR 50.3 expands on the ICH definition by stating that an investigator is the individual
“under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
investigator’s brochure A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects
L
legally acceptable representative An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.
Glossary- Clinical Trials Terminology – C – F
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Glossary- Clinical Trials Terminology – C – F
C
Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s), with the object 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
Cohort Group of subjects in a clinical trial followed up at regular, predetermined intervals
Comparative Study One in which the investigative drug is compared against another product, either active drug or placebo.
Comparator (product) An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.
Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.
Consent Form (CF)(also Informed Consent Form/Document – ICD) Document used during the consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved
Clinical Research Organization (CRO) A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trialrelated duties and functions.
D
Database: A collection of data, typically organized for easy search and retrieval. Data stored in computer form for
retrieval, processing, and/or analysis.
Data Monitoring Process by which case report forms are examined for completeness, consistency, and accuracy
Declaration of Helsinki A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. It was originally adopted by the 18th World Medical Assembly (Helsinki, Finland, 1964)
Demographic Data Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.
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 subject’s identities and sponsor’s proprietary information.
Dosage Regimen (a) The number of doses per given time period; (b) the time that elapses between doses (for example, every six hours) or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); or (c) the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time.
E
Effectiveness The desired measure of a drug’s influence on a disease condition as proved by substantial evidence from adequate and well-controlled investigations.
Efficacy A product’s ability to produce beneficial effects on the course or duration of a disease.
Endpoint An indicator measured in a subject or biological sample to assess the safety, efficacy, or other objective of a trial
Essential Documents Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Ethics Committee: An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Exclusion Criteria A list of criteria, any one of which excludes a potential subject from participation in a study
F
Final Report Complete, comprehensive description of a completed trial that describes the experimental materials and statistical design. It also presents and evaluates the trial results and statistical analyses
Food and Drug Administration (FDA) The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals
Glossary- Clinical Trials Terminology – A – C
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Glossary- Clinical Trials Terminology – A – C
A
Adverse Drug Reaction (ADR) In the preapproval clinical experience with a new medicinal product or its new usages, 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 marketedmedicinal products: 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
Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable 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
Audit (of a clinical trial) A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).
Audit Trail Documentation that allows reconstruction of the course of events.
B
Baseline Assessment Assessment of subjects as they enter a trial and before they receive any treatment.
Bioavailability Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body
Bioequivalence Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions.
Blind Study One in which the subject or the investigator (or both) are unaware of what trial product a subject is taking
Blinding/masking A procedure in which one or more parties to the trial are 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
Carry-Over Effect Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication’s known biological activity.
Case 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.
Causality Assessment Determining whether there is a reasonable possibility that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, dechallenge/rechallenge information, association (or lack of association) with underlying disease, and the presence (or absence) of a more likely cause
Clinical Research Associate (CRA) Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study.
Clinical Research Coordinator (CRC) Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before
a monitor’s visit.
Clinical Significance Change in a subject’s clinical condition regarded as important whether or not due to the test article. Some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol
Glossary- Clinical Trials Terminology – T to Z
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Glossary- Clinical Trials Terminology – T to Z
T
trial site The location(s) where trial-related activities are actually conducted.
triple-blind study A study in which knowledge of the treatment is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators.
Type 1 (or Type I) error Error made when a null hypothesis is rejected but is actually true. Also called false positive.
Type 2 (or Type II) error Error made when an alternative hypothesis is rejected when it is actually true. Also called false negative.
U
unequal randomization A technique used to allocate subjects into groups at a differential rate; for example, three
subjects may be assigned to a treatment group for every one assigned to the control group.
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).
V
validation of data Procedure carried out to ensure that the data contained in the final clinical trial report match original observations
vulnerable subjects Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or
impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads,
refugees, minors, and those incapable of giving consent.
W
washout period A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated
Warning Letter A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent
any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice.
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