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Clinical Research Terminology: This ppt has all important terms we use in clinical research. Meanings of those terms are also explained
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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
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