Educational Material

GLOSSARY and LIST OF ABBREVIATIONS IN CLINICAL RESEARCH

In the Clinical Research world, there are several terms and acronyms used. In fact, the existing diversity can represent a challenge to all professionals in the field, especially beginners. Thus, this document was created to improve the understanding and enable a quick consultation of some of the most used terms in the scope of Clinical Research. 

This document consists of an abbreviation list with some of the most common acronyms in this area and a glossary with the most used terms in Clinical Research, both in Portuguese and in English.

 

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a

Active comparator arm

Group of participants which receives a specific treatment considered to be effective (or active) by health care providers for a specific disease.

Adverse Drug Reaction

A response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function. It assumes that there is at least one possible causal relationship with the suspected drug.

Adverse Event

Any untoward medical occurrence in a patient or clinical investigation subject administered the pharmaceutical product that does not necessarily have to have a causal relationship with the treatment for which the product is used. For clinical studies, the definition of an Adverse Event includes any untoward events occurring at any time after the subject’s formal entry into the study (being after receipt of the signed informed consent) until the end of the follow-up period, as defined in the respective study protocol.

All-cause mortality

A measure of all deaths, due to any cause, that occur during a clinical study.

Allocation

A method used to assign participants to each arm of the clinical study. The types of allocation are randomized allocation and nonrandomized.

Annual Safety Report

An aggregate Safety Report in the context of clinical trials, considering all newly available safety information reported during a defined period. Where several clinical trials are conducted with the same Investigational Medicinal Product (IMP) the reporter should include a concise global analysis of the actual safety profile of the tested IMP based on the experience for all the clinical trials.

Applicable regulatory requirements

Laws and regulations addressing the conduct of clinical trials of investigational products.

Approval

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the competent authorities, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

Arm assignment

Participants are assigned to different arms of treatment, allowing the identifications of the interventions they are receiving.

Arm type

It identifies the type of intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, sham comparator arm, and no intervention arm.

Assessment

A procedure (e.g. a blood test, scan, etc.) used to generate data required by the trial.

Audit

A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analysed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).

Audit Certificate

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.

b

Background therapy

Background therapy is the current medication that is routinely taken as a standard of care for a particular condition/disease.

Baseline characteristics

Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).

Blinding

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

Case Report Form

Printed or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.

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 (see the ICH Guideline for Structure and Content of Clinical Study Reports).

Company Core Data Sheet

This document is prepared by the Marketing Authorization Holder and contains, in addition to safety information, material relating to indications, dosing, pharmacology and other aspects of the product.

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.

Concerned Member State

The Regulatory Authority in whose territory a clinical trial with the IMP is being conducted or is involved in the registration of a medicinal product in the EU under Mutual Recognition Procedures, as distinct from the Reference Member State that initiated the Procedure.

Confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.

Contract

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.

Contract Research Organization

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.

Coordinating Committee

 A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.

Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.

Cross-over trial

A clinical trial where groups of volunteers are administered two or more interventions in a specific order. For example, a “two-by-two” cross-over trial design is where one group receives drug A at the beginning of the trial and then receives drug B for the rest of the trial. In the second group, participants receive drug B first and then drug A. Thus, the term “cross-over” is used to describe the order in which they are assigned; for example, drug A and then drug B, or drug B and then drug A. All participants receive both drugs during the study.

d

Data Monitoring Committee

A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

Direct Access

Permission to examine, analyse, 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, sponsors, 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.

Documentation

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Dosing discontinuation

Point/time when a patient volunteer permanently stops taking study drug for any reason. This may be at the end of the study or before the end if the patient wants to stop taking the medicine for some reason.

Double-blind

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).

e

Early patient withdrawal (premature withdrawal)

Point/time when a patient exits from a trial prior to the planned completion of all investigational/trial drug administration and all assessments (including follow-up).

Early Phase 1 (formerly listed as Phase 0)

A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Eligibility Criteria

The requirements that people who want to participate in a clinical study must meet. Eligibility Criteria include both inclusion and exclusion criteria and are defined in the protocol.

Enrolment

The point, or time, of a volunteer’s entry into the trial, after informed consent has been obtained. The same term may also be used to define the number of participants in a clinical trial.

Essential Documents

Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

European Medicines Agency

An agency of the European Union that oversees the use of medicinal products.

Expedited Reporting

Notification (submission) of an ICSR in a designated format to the appropriate Regulatory Authorities in compliance with the parameters and timelines specified by legislation and local regulatory guidelines. An expedited report would be an ICSR meeting the criteria for rapid transmission to a Competent Authority.

Experimental arm

An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.

Extension request

In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health.

f

Factorial assignment

A type of intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So, during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants.

Food and Drug Administration

A government agency within the U.S. Department of Health and Human Services that oversees the Nation's public health by making sure that human and veterinary drugs, vaccines, biological products, medical devices, cosmetics, dietary supplements, the food supply, and any products that give off radiation are safe, effective, and secure.

g

Good Clinical Practice

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.

Group/Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.

h

Health Authority

A national or international health agency that has authority over and regulates a clinical study.

Healthcare Professional

Within the EU, a healthcare professional would be described as a medically qualified doctor, dentist, pharmacist, nurse, or coroner.  When the report originates from a pharmacist or nurse, further information should be sought from a medically qualified doctor responsible for the patient.

Human subjects' protection review board

A group of people who review, approve, and monitor the clinical study's protocol. Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the informed consent form. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee.

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

A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.

Independent 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, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Independent Ethics Committee

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/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 favourable 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.

Indication

A disease, symptom, or particular set of circumstances that make a particular test, medication, procedure, or surgery advisable. For a treatment, an indication refers to the use of that treatment in treating a particular disease.

Individual Case Safety Report

A report received by a company or agency which describes an adverse event.

Informed consent

Informed consent is used by researchers to explain the clinical trial to potential volunteers. Its purpose is to protect the participant. It is used when somebody who is interested in participating first asks about the study and it continues throughout the study, until the study ends. The research team will review the details of the trial with the potential participant and will answer any questions. This information is also written in a document, known as the informed consent form, which is designed to be clear and easy to understand. If a person decides to enrol in a clinical trial, they will sign the informed consent form to acknowledge that they understand the details of the trial and consent to participating. The informed consent form is not a contract and the participant can withdraw from the trial at any time, and for any reason.

Inspection

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

Institution (medical)

Any public or private entity or agency or medical or dental facility where clinical trials are conducted.

Institutional Review Board

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility 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 amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Interim Clinical Trial/Study Report

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

Intervention model

The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include single group assignment, parallel assignment, cross-over assignment, and factorial assignment.

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include non-invasive approaches, such as education or modifying diet and exercise.

Interventional Study

Also known as a clinical trial, a type of clinical study in which participants receive one or more interventions, according to the protocol and group that they are assigned to, so that researchers can evaluate the effects of the intervention on a health condition.

Investigational Medicinal Product

A investigational medicinal product is an active ingredient or placebo that has been formulated (developed) for human use and is being tested or used as a comparator in a Clinical Trial. Usually, IMPs haven’t yet received marketing authorization. However, in some cases, may be drugs that have been authorized for other indications or in other formulations, drugs used as active comparators, or drugs used to generate further information about na approved indication.

Investigator

A person responsible for conducting a Clinical Trial at a trial site. If a trial is conducted by a team of individuals at a trial site, one of the Investigators will be responsible for the team and may be called the Principal Investigator.

Investigator's Brochure

A compilation of the clinical and non-clinical data on the Investigational Medicinal Product relevant to the study of the product in humans.

l

Legal 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.

m

Marketing Authorisation

The approval granted by the Regulatory Authority to market a specific product in a particular country.

Marketing Authorisation Holder

The company named on the Marketing Authorisation for a specific product in a particular country.

Masking

A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include open label, single blind masking, and double-blind masking.

Medication number

A unique number on the label of each investigational drug package that is used in a trial to dispense and track medication. The number is used to make sure the drug is supplied in the right quantities to different research centres./p>

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 Plan

A document that describes the strategy, methods, responsibilities, and requirements for monitoring 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.

Multicentre 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

NCT number

A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).

Non-interventional Trial/Observational Study

A study where the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within the current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods should be used for the analysis of the collected data.

Nonclinical Study

Biomedical studies not performed on human subjects.

o

Outcome measure

For clinical trials, it is a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, it is a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.

p

Parallel assignment

A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So, during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.

Participant flow

A summary of the progress of participants through each stage of a clinical study, by study arm or group/cohort. This includes the number of participants who started, completed, and dropped out of the study.

Patient registry

A type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world.

Pharmacovigilance

The process of monitoring, evaluating, and improving the safety of medicines. It is carried out by pharmaceutical companies on their products and by government agencies on all medicinal products. Also, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems (WHO).

Phase

Categories, defined by the Food and Drug Administration (FDA), for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are four phases:

  • Phase I trials test an experimental drug, vaccine, or device in a small group of people to evaluate safety, identify side effects and determine safe dosages.
  • Phase II trials involve larger groups of people than Phase I and they are designed to assess whether an experimental treatment is safe and whether it works. This phase can last several years.
  • Phase III trials are usually large studies comparing the experimental drug or vaccine to a placebo or standard treatment, to evaluate whether the drug works and collect information to allow it to be used safely.
  • Phase IV trials are performed once a drug has reached the market, to provide additional information about the best use of the drug. /

Placebo

Placebos are inactive substances. In a clinical trial a placebo, made to look like the investigational treatment, is sometimes used to compare against the actual investigational treatment to evaluate effectiveness.

Post-authorisation safety study

A pharmacoepidemiologic study or a clinical trial carried out in accordance with the terms of the Marketing Authorization, with the aim of identifying or quantifying a safety hazard relating to an authorized medicinal product.

Post-authorization Study

A clinical study conducted within the conditions of the approved Summary of Product Characteristics or under normal conditions of use. A post-authorization study may also be a Post-authorization safety/efficacy study.

Primary outcome measure

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.

Primary purpose

The main reason for the clinical trial. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.

Principal Investigator

The person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical site.  In most cases the principal investigator will be a leading physician in the disease area being studied.

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.

q

Quality Assurance

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 GCP and the applicable regulatory requirement(s).

Quality Control

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.

r

Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments to reduce bias.

Randomization number

A unique number assigned to each randomized patient that is used to identify individuals but maintain anonymity, corresponding to a specific study arm assignment.

Randomized allocation

A strategy in which participants are randomly assigned to study arms of a clinical trial by computer.

Recruitment status

  • Not yet recruiting: The study has not started recruiting participants.
  • Recruiting: The study is currently recruiting participants.
  • Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
  • Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
  • Suspended: The study has stopped early but may start again.
  • Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
  • Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
  • Withdrawn: The study stopped early, before enrolling its first participant.
  • Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years. /

Registration

The process of submitting and updating summary information about a clinical study and its protocol, from its beginning to end, to a structured, public Web-based study registry that is accessible to the public, such as ClinicalTrials.gov.

Regulatory Authorities

Bodies having the power to regulate. In the ICH GCP guidance, the expression "Regulatory Authorities" includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities.

Risk Management System

A set of Pharmacovigilance activities and interventions designed to proactively identify, characterize and prevent or minimize risks relating to Medicinal Products, including risk communication and the assessment of the effectiveness of risk minimization and interventions.

Run-in period

The elapsed time before a trial starts when no investigational drug is given to trial participants. During this time patients may still receive standard treatments for their disease if these treatments are allowed within the trial period.

s

Secondary outcome measure

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.

Serious Adverse Event

Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Sham comparator arm

An arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components.

Single group assignment

A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.

Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original record or certified copies).

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 and complete, 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).

Sponsor

An individual, company, institution, or organization which 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). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

Spontaneous Report

An unsolicited communication by a regulatory authority, healthcare professional, consumer or other person that describes an ADR/AE in a patient administered the Product and which does not derive from a study or any organized data collection scheme.

Standard Operating Procedures

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Statistical Analysis Plan

The written description of the statistical considerations and methods for analysing the data collected in the clinical study.

Study completed date

The date on which the last trial participant made the final visit to the study location (that is, "last subject, last visit") and the last samples were collected, or last tests performed.

Subinvestigator

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).

Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

Subject/Trial Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

t

Title

The official title of a protocol used to identify a clinical study, or a short title written in language intended for the lay public.

Title acronym

The acronym or initials used to identify a clinical study (not all studies have one). For example, the title acronym for the Women's Health Initiative is "WHI."

Trial Site

The location(s) where trial-related activities are conducted.

u

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 Computerized Systems

A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

Variable

Information collected during a clinical trial either from direct or indirect data. For example, one variable might be “weight,” which would then be checked at specified time points throughout the trial.

Vulnerable Subjects

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

Wash-out period

The period allowed for all the administered drug to be eliminated from the body.