Clinical Research Terminology

TERMINOLOGY IN CLINICAL RESEARCH

- PRIYANKA KAMDAR

Systematic study of drug/device in human subjects

Investigation in human subjects intended to discover clinical/pharmacodynamic effects of IP

To identify adverse reactions to IP To study absorption, distribution,

metabolism and excretion of IP with the objective to ascertain its safety and efficacy

CLINICAL TRIAL

International ethical and scientific quality standard for designing, conducting, monitoring, recording, reporting, auditing clinical studies

Ensures that data reported is credible and accurate, and that subject’s rights and confidentiality are protected

GOOD CLINICAL PRACTICE (GCP)

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

PROTOCOL

Compilation of clinical and nonclinical data on the investigational product relevant to study of IP in human subjects

INVESTIGATOR BROCHURE

Process by which subject voluntarily confirms his or her willingness to participate

Precedes enrollment

Documented by means of written, signed and dated consent form

INFORMED CONSENT

Inclusion: Criteria that prospective subjects must meet to be eligible for participation in study

Exclusion: list of criteria which excludes potential subject from participation in study

INCLUSION/EXCLUSION CRITERIA

An independent body constituted of medical/scientific and non-scientific members

To ensure protection of rights, safety and well-being of human subjects in a trial

Provide protection by reviewing and approving/providing favourable opinion on the protocol

Checks the suitability of investigators, facilities, methods to be used in obtaining and documenting informed consent

INDEPENDENT ETHICS COMMITTEE

Composition, functions, operations pertaining to IEC may differ among countries

But should allow the IEC to act in agreement with GCP

Individual who is a participant in research

May be either a healthy human or patient

Should have signed the informed consent document prior to his participation in a study

HUMAN SUBJECT

Untoward medical occurrence in patient administered pharmaceutical product

Does not necessarily have causal relationship with the treatment

Can be any unintended sign

When an AE has been determined to be related to the investigational product, it is considered an Adverse Drug Reaction

ADVERSE EVENT

Baseline assessment: assessment of subjects as they enter a trial and before they receive any treatment

Randomisation: process of assigning trial subjects to treatment/control groups using element of chance

BASELINE/RANDOMISATION

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

OPEN LABEL TRIAL

Study in which neither the subject nor investigator nor research team know what treatment subject is receiving

The expectations of the doctor/participant about the experimental drug do not affect the outcome

"Blinded" studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known

DOUBLE-BLIND STUDY

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.

Printed, electronic document designed to record protocol-required information to be reported to sponsor

Record of clinical study observations that a protocol designates must be completed

CASE REPORT FORM

CRA:Person employed by sponsor/CRO who monitors progress of investigator sites

CRC: person who handles most of administrative responsibilities of trial

Acts as a liasion between the site and sponsor

Reviews all data and records before monitor’s visit

CLINICAL RESEARCH ASSOCIATE/CLINICAL RESEARCH COORDINATOR

Written description of trial/study conducted in human subjects in which clinical/statistical description, analysis are integrated into single report

CLINICAL STUDY REPORT

In which the investigative drug is compared against another product (active drug/placebo)

A comparator is an investigational/marketed product or placebo used as a reference

COMPARATIVE STUDY

Organisation contracted by sponsor to perform one or more of sponsor’s trial-related duties and functions

CONTRACT RESEARCH ORGANISATION (CRO)

Researchers who periodically review data from clinical studies

An independent committee composed of clinical research experts

It reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk

A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved

DATA AND SAFETY MONITORING BOARD (DSMB)

Set of recommendations/basic principles that guide medical doctors in conduct of research involving human subjects

Published first in 1964 sought to address ethical aspects of clinical research

Has made informed consent a central requirement for ethical research

DECLARATION OF HELSINKI

Research in vulnerable groups should be conducted only if necessary to promote the health of that population

Benefits, risks, effectiveness of new method should be tested against best current methods

Electronic record designed to record information required by the protocol to be reported to sponsor on each trial subject

eCRF

Person who is independent of the trial who attends the informed consent process if subject or his LAR cannot read

Impartial witness reads the informed consent form and any other written information supplied to the subject

IMPARTIAL WITNESS

Individual or other body authorised to consent on behalf of prospective subject about the subject’s participation in clinical trial

LEGALLY ACCEPTABLE REPRESENTATIVE

Active ingredient or placebo being tested/used in clinical trial

Includes a product with marketing authorisation when used for unapproved condition, or when used to gain further information about an approved use

INVESTIGATIONAL PRODUCT

A planned analysis intended to compare treatment arms with regards to safety and efficacy at any time prior to completion of trial

Determined as part of the study protocol

INTERIM ANALYSIS

Person responsible for conduct of clinical trial at the site

Investigator is the responsible leader of the team

INVESTIGATOR

Act of overseeing progress of a clinical trial

Ensuring it is conducted, recorded and reported in accordance with protocol, SOP, GCP

A written report submitted to the sponsor by the monitor after each site visit is called monitoring report

MONITORING

Term used for adverse event monitoring and reporting

The science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problems

PHARMACOVIGILANCE

A new drug, antibiotic drug, or biological drug that is used in a clinical investigation

IND application is a petition through which a drug sponsor requests the regulatory authority to allow human testing of its new drug product

INVESTIGATIONAL NEW DRUG

The compilation of all non-clinical, clinical, pharmacological, pharmacokinetic and stability information required about a drug by the regulatory authority in order to approve the drug for marketing

NEW DRUG APPLICATION (NDA)

The standard against which experimental observations are compared and evaluated

In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo

CONTROL GROUP

Before a drug may be tested on humans, pre-clinical studies must be conducted on animals to determine that the drug is safe

PRE-CLINICAL TESTING

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

RANDOMISATION

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 OPERATING PROCEDURES (SOPs)

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)

VULNERABLE SUBJECTS

Study supplies (i.e., study test article, laboratory supplies, case report forms) provided by the study sponsor to the investigator

CLINICAL STUDY MATERIAL

Study of processes of bodily absorption, distribution, metabolism and excretion of compounds and medicines

PHARMACOKINETICS

Ongoing safety monitoring of marketed drugs

Phase 4 studies

POSTMARKETING SURVEILLANCE

Treatment currently in wide use and approved by FDA or other health authority, considered to be effective in treatment of specific disease or condition

STANDARD TREATMENT

Plan for precise procedure to be followed in clinical trial

Includes planned and actual timing of events, method of allocating treatments

STUDY DESIGN

Systematic and independent examination of trial-related activities and documents

Determines if trial was conducted and data recorded, analysed and accurately reported acc. to protocol, GCP etc.

Audit report is written evaluation by the sponsor’s auditor of the results of audit

AUDIT