Glossary
Here we provide some concise definitions of the various technical terms used throughout our site, with references to relevant sources, when applicable.
A
Adverse Drug Reaction, ADR: any noxious and unintended effect resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product.
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.
Annual Safety Update Report, ASUR or Development Safety Update Report, DSUR or : a document aiming to present a comprehensive annual review and evaluation of safety information, collected during the reporting period. [read more]
Audit: a systematic and independent examination to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, SOPs, GCP and the applicable regulatory requirement(s). [read more]
B
Biological marker (biomarker): a characteristic that is objectively measured and evaluated as an indicator of normal or abnormal biological processes. [read more]
C
Case Report Form, (e)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.
Clinical endpoint: a characteristic or variable that reflects how a patient feels, functions, or survives.
Clinical Research Associate, CRA: a health-care professional, usually hired by a CRO to perform a variety of monitoring activities, such as ensuring compliance with the clinical trial protocol, checking clinical site activities, making on-site visits, reviewing CRFs, and communicating with clinical research coordinators.
Clinical Research Coordinator, CRC or Study-Site Coordinator, SSC: a health-care professional responsible for conducting clinical trials using GCP under the auspices of a PI.
Clinical Study Protocol, CSP: a document that describes the objective(s), design, methodology, statistical consideration, and organisation of a trial. [SPIRIT 2013]
Clinical Study Report, CSR: 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.
Compliance: adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.
Contract Research Organisation, CRO: a person or an organisation (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions. [visit ACRO]
D
Due Diligence: the investigation or exercise of care that a reasonable business or person is expected to take before entering into an agreement or contract with another party.
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. [GCP guideline E6]
H
Health Care Professional, HCP: any member of the medical, pharmacy or nursing professions or any other person who in the course of his or her professional activities may prescribe, administer or dispense to an end-user a medicinal product.
I
Independent Data Monitoring Committee, IDMC or Data Safety Monitoring Board, DSMB: 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. [DSMBs by NHMRC]
Independent Ethics Committee, IEC or Institutional Review Board, IRB: an independent body (a review board or a committee, institutional, regional, national or supranational), constituted of medical professionals and non-medical 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 reviewing and approving on the trial protocol, the suitability of the investigator(s), facilities and the methods and material to be used in obtaining and documented informed consent of the trial subjects.
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. It is documented by means of a written, signed and dated informed consent form. [read more]
Inspection: the act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or CRO’s facilities or at other establishments deemed appropriate by the regulatory authorities. [read more]
International Conference on Harmonisation, ICH: an organisation which provides consistency in standards applied to clinical trials worldwide by bringing together representatives from regulatory authorities and pharmaceutical industry associations in Europe, Japan and the USA. [visit ICH]
Investigator’s Brochure, IB: 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.
Investigational Medicinal Product, IMP or Investigational New Drug, IND: a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial.
K
Key Opinion Leader, KOL: a person or organisation who has expert product knowledge and influence in a respective field.
L
Life-Cycle Management, LCM: the succession of strategies by business management as a medicinal product goes through its life-cycle (pre-launch, launch, growth, maturity & decline).
M
Medical Advisory Board: a meeting of a group of HCPs, often KOLs, headed by a chairperson, discussing a topic in the company’s fields of expertise in order to obtain expert feedback on various aspects related to a product or disease state.
Medical Dictionary for Regulatory Activities, MedDRA: nomenclature used to ensure consistent medical terminology is used throughout. [visit MedDRA]
Meta-Analysis: a statistical analysis that combines the results of multiple clinical studies studies. [read more]
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, SOPs, GCP and the applicable regulatory requirement(s).
P
Patient Profile: an individualised display of patient data, providing a complete picture of the subject’s status and the possibility to easily identify issues in the database.
Phase I Clinical Trial (pharmacology): a trial designed to examine the biological and pharmacological actions, tolerability and safety of an IMP in healthy individuals (n=30-150).
Phase II Clinical Trial (exploratory): a trial designed to define the spectrum of activity of an IMP administered at an optimal schedule and dose in a small clinical population (n=100-150).
Phase III Clinical Trial (confirmatory): a trial designed to confirm the activity of an IMP in a claimed indication in a large clinical population (n=100-1,000).
Phase IV Clinical Trial (therapeutic use): a post-marketing study gathering additional safety data and monitoring efficacy in a larger patient population (n=500-5,000).
Principal Investigator, PI: the responsible medical leader for the conduct of the clinical trial at a trial site.
Proof of Concept Trial, PoC: another term for an early clinical trial of an IMP, conventionally divided into Phase I and Phase II.
Proof of Mechanism Trial, PoM: a preclinical trial aiming to show that the an IMP interacts with the intended molecular receptor or enzyme, and/or affects cell biochemistry in the desired manner and direction.
Proof of Principle Trial, PoP: an early clinical trial, aiming to show that an IMP has an effect on disease biomarkers, but not the clinical endpoints of the condition.
Protocol Amendment: a written description of a change(s) or formal clarification of a clinical protocol.
Protocol Deviation: accidental or unintentional changes to, or non-compliance with the clinical protocol; usually does not increase risk or decrease benefit or; does not have a significant effect on the subject's rights, safety or welfare; and/or on the integrity of the data. More severe protocol deviations, with impact on safety and welfare of study subjects and/or integrity of data, are referred as protocol violations.
R
Regulatory or Competent Authorities: authorities having the power to regulate clinical trials by reviewing submitted clinical data and conducting inspections. [visit FDA] [visit EMA]
S
Scientific Communication Platform, SCP: the foundation of a strong medical communications strategy for a pharmaceutical product or device, serving as an important tool to align communications and messaging across functional areas.
Site Management Organisation, SMO: an organisation that provides clinical trial related services to a CRO, a pharmaceutical company, a biotechnology company, a medical device company or a clinical site.
Serious Adverse Event, SAE or Drug Reaction, SADR: any adverse event or adverse drug reaction that resulted in a fatal outcome or is life threatening; led to hospitalisation or prolonged hospitalisation; led to persistent or significant disability; resulted in congenital abnormality; or considered medically significant for other reasons. [read more]
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. Contained in Source Documents.
Sponsor: an individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Standard Operating Procedure, SOP: detailed, written instructions to achieve uniformity of the performance of a specific function.
Subinvestigator, SI: an individual member of the clinical trial team designated and supervised by the principal investigator at a trial site to perform critical trial-related procedures and/or to make important trial related decisions.
Surrogate endpoint: a biomarker that is intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit (or harm or lack of benefit or harm) based on epidemiological, therapeutic, pathophysiologic, or other scientific evidence. [read more]
Suspected Unexpected Serious Drug Reaction, SUSAR: a serious adverse drug reaction whose nature, severity, specificity or outcome is not consistent with the product information.
Systematic Review: a type of literature review that uses systematic methods to collect secondary data, critically appraise research studies and synthesise findings qualitatively or quantitatively. [read more]
T
Target Product Profile, TPP: a one-page road map summary to guide clinical development of a medicinal product; usually covers the topics of the targeted major unmet needs, the major attributes of the product, and how these attributes will address the unmet needs in question. [TPP guideline WHO]
U
Unexpected Drug Reaction, UDR: an adverse drug reaction whose nature or severity is not consistent with the applicable product information.