The following is a list of clinical trials terms. For a list
of abbreviations, please click here.
AAUCMB
Average Area Under the Curve Minus Baseline
ABS
Abacavir
ACR 20
American College of Rheumatology 20% responder rate
ADE
AIDS- Defining Event
ADR – see Adverse Drug Reaction
Adverse Drug Reaction (ADR)
An unintended reaction to a drug taken at doses normally used
in man for prophylaxis, diagnosis, or therapy of disease, or for
the modification of physiological function. In clinical trials,
an ADR would include any injuries by overdosing, abuse/dependence,
and unintended interactions with other medicinal products.
Adverse Event (AE)
A negative experience encountered by an individual during the
course of a clinical trial, that is associated with the drug.
An AE can include previously undetected symptoms, or the exacerbation
of a pre-existing condition. When an AE has been determined to
be related to the investigational product, it is considered an
Adverse Drug Reaction.
Adverse Event Reports
Investigator reports of all serious and adverse events, injury
and deaths given to the sponsor, the IRB and the FDA or appropriate
regulatory body
Ae
Amount excreted in urine
Aet
Cumulative urinary excretion from administration until time t
AE – see Adverse Event
AIDS
Acquired Immunodeficiency Deficiency Syndrome
ALT
Al anine aminotransferse
ANC
Absolute Neutrophil Count
ANCOVA
Analysis of covariance
ANOVA
Analysis of variances
Anti-HAT
Humanized Anti-Tac
Anti-TNF
Anti-Tumor Necrosis Factor
Anti-TNFα
Anti-Tumor Necrosis Factor-alpha
APV
Amprenavir
ARA
American Rheumatism Association
ARV
Antiretroviral
AUC
Area Under the Curve
AUC0-∞
Area Under the Curve time 0-time infinity
AUCinf
Area under the Curve time infinity
AUCMB
Area under the Curve minus baseline
Assurance
A renewable permit granted by the federal government to an institution
or research center to conduct clinical trials.
Bid
bis in die (twice daily)
Biologic
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product, or analogous
product applicable to the prevention, treatment or cure of diseases
or injuries of man.
Biotechnology
Any technique that uses living organisms, or substances from organisms,
biological systems, or processes to make or modify a product or
process, to change plants or animals, or to develop micro-organisms
for specific uses.
BL
Baseline
Blinding
The process through which one or more parties to a clinical trial
are unaware of the treatment assignments. In a single-blinded
study, usually the subjects are unaware of the treatment assignments.
In a double-blinded study, both the subjects and the investigators
are unaware of the treatment assignments. Also, in a double-blinded
study, the monitors and sometimes the data analysts are unaware.
"Blinded" studies are conducted to prevent the unintentional
biases that can affect subject data when treatment assignments
are known.
BLQ
Below Limit of Quantification
CA – see Competent Authority
Case Report Form (CRF)
A record of pertinent information collected on each subject during
a clinical trial, as outlined in the study protocol.
CCRC – see Certified Clinical Research Coordinator
Certified Clinical Research Coordinator (CCRC)
CRC with >2 years experience and with certification earned
by passing required program and exam.
CI
Confidence Interval
Clinical Investigation
A systematic study designed to evaluate a product (drug, device,
or biologic) using human subjects, in the treatment, prevention,
or diagnosis of a disease or condition, as determined by the product's
benefits relative to its risks. Clinical investigations can only
be conducted with the approval of a governing body such as the
Food and Drug Administration (FDA) or appropriate regulatory body.
Clinical Research
Study of drug, biologic or device in human subjects with the intent
to discover potential beneficial effects and/or determine its
safety and efficacy. Also called clinical study and clinical investigation.
Note that in this glossary, this term is used in its narrow sense
as used by governing bodies such as the FDA. Thus, it does not
encompass all the research that is carried out in the clinical
setting (e.g., health services research).
Clinical Research Associate (CRA)
Person employed by the study sponsor or CRO to monitor a clinical
study at all participating sites. See also, monitor.
Clinical Research Coordinator (CRC)
Site administrator for the clinical study. Duties are delegated
by the investigator. Also called research, study or healthcare
coordinator, and data manager, research nurse or protocol nurse.
Clinical Study Materials
Study supplies (i.e., study test article, laboratory supplies,
case report forms) provided by the study sponsor to the investigator.
Clinical Trial
Any investigation in human subjects intended to determine the
clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic
effects of an investigational agent, and/or to identify any adverse
reactions to an investigational agent to assess the agent's safety
and efficacy.
CL/F
Apparent clearance
CLdtot
Total distribution clearance
CLiv
Clearance after iv administration
CLpo
Oral clearance
CLR
Renal clearance
Cmax
Maximum plasma concentration
Cmin
Minimum plasma concentration
CMV
Cytomegalovirus retinitis
CMVR
Cytomegalovirus retinitis
Competent Authority (CA)
A national agency responsible under its national law for the control
or regulation of a particular area, in this case pertaining to
the control and regulation of clinical trials.
Consent Form
A document explaining all relevant study information to assist
the study volunteer in understanding the expectations and requirements
of participation in a clinical trial. This document is presented
to and signed by the study subject.
Contract Research Organization (CRO)
A person or an organization (commercial, academic or other) contracted
by the sponsor to perform one or more of a sponsor's study-related
duties and functions.
Control Group
A comparison group of study subjects who are not treated with
the investigational agent. The subjects in this group may receive
no therapy, a different therapy, or a placebo.
CRA – see Clinical Research Associate
CRC – see Clinical Research Coordinator
CrCl
Creatinine Clearance
CRF – see Case Report Form
CRO – see Contract Research Organization
CRP
C-reactive protein
Css
Plasma concentration at steady state
Cthrough
Through plasma concentration
CTx
C-telopeptide
d
day
D+
Cytomegalovirus-seropositive donor
DAR – see Drug or Device Accountability
Records
Data
This term is legally defined according to the institution. It
generally refers to recorded information regardless of form. Most
institutions hold title to data while researchers have rights
to access the data.
Data Management
The process of handling the data gathered during a clinical trial.
May also refer to the department responsible for managing data
entry and database generation and/or maintenance.
Declaration of Helsinki
A series of guidelines adopted by the 18th World Medical Assembly
in Helsinki, Finland in 1964. The Declaration addresses ethical
issues for physicians conducting biomedical research involving
human subjects. Recommendations include the procedures required
to ensure subject safety in clinical trials, including informed
consent and Ethics Committee reviews.
Demographic Data
Refers to the characteristics of study participants, including
sex, age, family medical history, and other characteristics relevant
to the study in which they are enrolled.
Device
An instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including
any component, part or accessory, which is intended for use in
the diagnosis, cure, treatment or prevention of disease. A device
does not achieve its intended purpose through chemical action
in the body and is not dependent upon being metabolized to achieve
its purpose.
Diagnostic interventional clinical trial
A diagnostic interventional trial assigns a group of human subjects to
intervention based on the results of diagnostic tests and in most cases
a comparison group to follow standard procedures. In that way the
cause-and-effect relationship between a diagnostic test, a resulting
medical intervention and a health outcome can be studied.
dL
deciliter
DMARD
Disease-Modifying Anti-Rheumatic Drug
Documentation
All forms of records that describe or document study methods,
conduct and results, including any adverse events and actions
taken.
Double-Blind
The design of a study in which neither the investigator nor the
subject knows which medication (or placebo) the subject is receiving.
Drug
As defined by the Food, Drug and Cosmetic Act, drugs are "articles
(other than food) intended for the use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other
animals, or to affect the structure or any function of the body
of man or other animals."
Drug Product
A finished dosage form (e.g. tablet, capsule, or solution) that
contains the active drug ingredient usually combined with inactive
ingredients.
Drug or Device Accountability Records (DAR)
Required documentation for material accountability, quantity used
and left over, and date of disposal.
DT
Diphtheria/Tetanus
ECG/EKG
Electrocardiogram
Effective Dose
The dose of an investigational agent that produces the outcome
considered "effective," as defined in the study protocol.
This could mean a cure of the disease in question or simply the
mitigation of symptoms.
Efficacy
A product's ability to produce beneficial effects on the duration
or course of a disease. Efficacy is measured by evaluating the
clinical and statistical results of clinical tests.
EFV
Efavirenz
EMEA – see European Medicines Agency
EORTC
European Organization for Research and Treatment of Cancer
ESR
Erythrocyte Sedimentation Rate
Ethics Committee
An independent group of both medical and non-medical professionals
who are responsible for verifying the integrity of a study and
ensuring the safety, integrity, and human rights of the study
participants.
European Medicines Agency (EMEA)
A decentralised body of the European Union with headquarters in
London. Its main responsibility is the protection and promotion
of public and animal health, through the evaluation and supervision
of medicines for human and veterinary use. The EMEA coordinates
the evaluation and supervision of medicinal products throughout
the European Union. The Agency brings together the scientific
resources of the 25 EU Member States in a network of 42 national
competent authorities. It cooperates closely with international
partners, reinforcing the EU contribution to global harmonisation.
Exclusion Criteria
Refers to the characteristics that would prevent a subject from
participating in a clinical trial, as outlined in the study protocol.
F
Bioavailability
FDA – see Food and Drug Administration
Food and Drug Administration (FDA)
Department within the United States Department of Health and Human
Services. Enforces Food, Drug and Cosmetics Act and related federal
public health laws. Grants IND, IDE, PMA and NDA approvals.
Formulation
The mixture of chemicals and/or biological substances and excipients
used to prepare dosage forms.
FSGS
Focal Segmental Glomerulosclerosis
g
gram
GC-MS
Gas Chromatograph Mass Spectrometer
GCP – see Good Clinical Practice
Generic Drug
A medicinal product with the same active ingredient, but not necessarily
the same inactive ingredients as a brand-name drug. A generic
drug may only be marketed after the original drug's patent has
expired.
GGT
Gamma-Glutamyl Transferase
Good Clinical Practice (GCP)
International ethical and scientific quality standard for designing,
conducting, monitoring, recording, auditing, analyzing and reporting
studies. Insures that the data reported is credible and accurate,
and that subject's rights and confidentiality are protected.
HAART
Highly Active Antiretroviral Therapy
HAQ
Health Assessment Questionaire
HIV
Human Immunodeficiency Virus
Human Subject
A patient or healthy individual participating in a research study.
A living individual about whom an investigator obtains private
information or data through intervention or interaction.
hr
hour
Top ^
IEC – see Independent Ethics Committee
Inclusion Criteria
Refers to the characteristics that must be met by a subject in
order to participate in a clinical trial, as outlined in the study
protocol.
IND – see Investigational New Drug Application
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-medical/nonscientific 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.
Informed Consent
The voluntary verification of a patient's willingness to participate
in a clinical trial, along with the documentation thereof. This
verification is requested only after complete, objective information
has been given about the trial, including an explanation of the
study's objectives, potential benefits, risks and inconveniences,
alternative therapies available, and of the subject's rights and
responsibilities in accordance with the current revision of the
Declaration of Helsinki.
Institution
Location of research. Retains ultimate responsibility for human
subject regulation compliance.
Institutional Review Board (IRB)
An independent group of professionals designated to review and
approve the clinical protocol, informed consent forms, study advertisements,
and patient brochures, to ensure that the study is safe and effective
for human participation. It is also the IRB's responsibility to
ensure that the study adheres to regulations of a a regulatory
body such as the FDA.
Investigational New Drug Application (IND)
The petition through which a drug sponsor requests the FDA to
allow human testing of its drug product.
Investigator
A medical professional, usually a physician but may also be a
nurse, pharmacist or other health care professional, under whose
direction an investigational drug is administered or dispensed.
A principal investigator is responsible for the overall conduct
of the clinical trial at his/her site.
Investigator's Brochure
Relevant clinical and non-clinical data compiled on the investigational
drug, biologic or device being studied.
In Vitro Testing
Non-clinical testing conducted in an artificial environment such
as a test tube or culture medium.
In Vivo Testing
Testing conducted in living animal and human systems.
IRB – see Institutional Review Board
ISR
Injection Site Reaction
ITT
Intention To Treat
Iv
Intravenous
Kel
Elimination constant
kg
kilogram
LC/MS/MS methods
Liquid Chromatography mass spectrometery
LOCF
Last Observation Carried Forward
Longitudinal Study
A study conducted over a long period of time.
LSM
Least Squares Mean
m
meter
MedWatch Program
An FDA program designed to monitor adverse events (AE) from drugs
marketed in the U.S. Through the MedWatch program, health professionals
may report AEs voluntarily to the FDA. Drug manufacturers are
required to report all AEs brought to their attention.
mcg
microgram
mg
milligram
MITT
Modified Intention To Treat
mL
millilitre
mm
millimetre
mmol
millimole
Monitor
Person employed by the sponsor or CRO who reviews study records
to determine that a study 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 study, and assessing the conduct
of studies. Monitors work with the clinical research coordinator
to check all data and documentation from the study. See also CRA.
Monitoring
Reviewing a clinical study, ensuring conduct, proper records and
reports are performed as stated in the clinical protocol, standard
operating procedures, GCP and by regulatory requirements.
MOS
Medical Outcomes Study
MPA
Mycophenolic Acid
MPAG
Mycophenolic Acid Glucuronide
Multiple Project Assurance
Permit given to institution for multiple federally funded research
grants for a specified period of time. States institution retains
responsibility for all research involving humans and that the
institution must have an established IRB.
MTX
Methotrexate
NAG
N-acetyl-β-D-glucosaminidase
NDA – see New Drug Application
New Drug Application (NDA)
The compilation of all non-clinical, clinical, pharmacological,
pharmacokinetic and stability information required about a drug
by the FDA in order to approve the drug for marketing in the U.S.
ng
nanogram
Nuremberg Code
As a result of the medical experimentation conducted by Nazis
during World War II, the U.S. Military Tribunal in Nuremberg in
1947 set forth a code of medical ethics for researchers conducting
clinical trials. The code is designed to protect the safety and
integrity of study participants.
OB
Optimized Background
Off Label
The unauthorized use of a drug for a purpose other than that approved
of by a regulatory body such as the FDA.
Office for Human Research Protection (OHRP)
A U.S. federal government agency that issues Assurances and overseas
compliance of regulatory guidelines by research institutions.
OHRP – see Office for Human Research Protection
Open-Label Study
A study in which all parties, (patient, physician and study coordinator)
are informed of the drug and dose being administered. In an open-label
study, none of the participants are given placebos. These are
usually conducted with Phase I & II studies.
Orphan Drug
A designation of the FDA to indicate a therapy developed to treat
a rare disease (one which afflicts a U.S. population of less than
200,000 people). Because there are few financial incentives for
drug companies to develop therapies for diseases that afflict
so few people, the U.S. government offers additional incentives
to drug companies (i.e. tax advantages and extended marketing
exclusivity) that develop these drugs.
OTC – see Over-the-Counter
Over-the-Counter (OTC)
Drugs available for purchase without a physician's prescription.
Patient
Individual seeking medical care.
PD
Pharmacodynamics
Pharmacoeconomics
The study of cost-benefit ratios of drugs with other therapies
or with similar drugs. Pharmacoeconomic studies compare various
treatment options in terms of their cost, both financial and quality-of-life.
Also referred to as "outcomes research".
Phase I-IV Studies
For a complete description of the definitions of Phase I-IV please
click here.
PI
Protease Inhibitor
Pivotal Study
Usually a phase III study that presents the data a governing body
(e.g. the FDA) uses to decide whether or not to approve a drug.
A pivotal study will generally be well-controlled, randomized,
of adequate size, and whenever possible, double-blind.
PK
Pharmacokinetic
Placebo
An inactive substance designed to resemble the drug being tested.
It is used as a control to rule out any psychological effects
testing may present. Most well-designed studies include a control
group which is unwittingly taking a placebo.
PNBC
Periods with New Bone Complications
Po
per os (oral)
Pre-Clinical Testing
Before a drug may be tested on humans, pre-clinical studies must
be conducted either in vitro but usually in vivo on animals to
determine that the drug is safe.
Protocol
A detailed plan that sets forth the objectives, study design,
and methodology for a clinical trial. A study protocol must be
approved by an IRB before investigational drugs may be administered
to humans.
Protocol Amendment
Changes or clarifications made in writing to the original protocol.
Pts-yrs
Patient-years
PWFU
Patients who Withdrew From study prematurely
q12h
every 12 hours
QLQ-C30
Quality of Life Questionnaire-core 30
QOL
Quality Of Life
qow
every other week
Quality Assurance
Systems and procedures designed to ensure that a study is being
performed in compliance with Good Clinical Practice (GCP) guidelines
and that the data being generated is accurate.
R-
Cytomegalovirus-seronegative
RA
Rheumatoid arthritis
Randomization
Study participants are usually assigned to groups in such a way
that each participant has an equal chance of being assigned to
each treatment (or control) group. Since randomization ensures
that no specific criteria are used to assign any patients to a
particular group, all the groups will be equally comparable.
Recruitment
Act of enrolling subjects with the proper inclusion criteria.
Recruitment Period
Time allowed to enroll all subjects for a study.
Regulatory Affairs
In clinical trials, the department or function that is responsible
for ensuring compliance with government regulations and interacts
with the regulatory agencies. Each drug sponsor has a regulatory
affairs department that manages the entire drug approval process.
Research
Systematic investigation designed to develop or contribute to
generalizable knowledge. Includes Clinical Research.
Research Team
Investigator, subinvestigator and clinical research coordinator
involved with study.
Risk-Benefit Ratio
Risk to individual subject vs. potential benefits. Also called
Risk-Benefit Analysis.
RNA
Ribonucleic Acid
RT
Restricted Treated
RTV
Ritonavir
SAE – see Serious Adverse Event
Safety Reports
FDA or other regulatory body reports required by investigator
for any serious and unexpected adverse experience.
sc
subcutaneous
SD
Standard Deviation
SEM
Standard Error of the Mean
Serious Adverse Event (SAE)
Any adverse event (AE) that is fatal, life-threatening, permanently
disabling, or which results in hospitalization, initial or prolonged.
SF-36
Short-Form 36
Single Project Assurance
Permit given to institution for single grant in compliance with
government standards. See "assurance."
SMPR
Skeletal Morbidity Period Rate
SOP – see Standard Operating Procedure
SOT
Solid Organ Transplant
Source Data
All information contained in original records and certified copies
of results, observations or other facets required for the reconstruction
and evaluation of the study that is contained in source documents.
Source Documentation
Location where information is first recorded including original
documents, data and records.
Sponsor
Individual, company, institution or organization taking responsibility
for initiation, management and financing of study.
Standard Operating Procedure (SOP)
Official, detailed, written instructions for the management of
clinical trials. SOPs ensure that all the functions and activities
of a clinical trial are carried out in a consistent and efficient
manner.
Standard Treatment
The currently accepted treatment or intervention considered to
be effective in the treatment of a specific disease or condition.
Sub-investigator
Helps design and conduct investigation at a study site.
Subject/Study Subject
Participant in a study. See "Human Subject."
t1/2p
Bioloogical half-life of parent compound
t1/2u
Urinary half-life
TBW
Total Body Weight
Telephone Report
Notification via telephone to the FDA of unexpected fatal or life
threatening advent associated with a clinical study.
tid
thrice daily
Tmax
Time to maximum plasma concentration
Treatment IND
A method through which the FDA allows seriously ill patients with
no acceptable therapeutic alternative to access promising investigational
drugs still in clinical development. The drug must show "sufficient
evidence of safety and effectiveness." In recent decades
many AIDs patients have been able to access unapproved therapies
through this program.
TT
Tetanus Toxoid
Unexpected Adverse Drug Reaction
A reaction that is not consistent in nature or severity with study
application.
V1
Central (vascular) compartment
V2
Peripheral (extra-vascular) compartment
Vss
volume of distribution at steady state
Vulnerable Subjects
Group/individual that cannot give informed consent because of
limited autonomy (e.g., children, mentally ill and prisoners).
Also refers to subjects who may be unduly influenced to participate
(e.g., students, subordinates and patients).
WHO
World Health Organization
WHO PS
World Health Organization Performance Status
Well-being
Subject's physical and mental soundness.
Withdrawal Application
Investigator/sponsor letter to FDA or other regulatory body requesting
application withdrawal when no additional work is envisioned.
yr
year
