Clinical trial glossary for words and terms that are often used.
Adverse Event
Any unexpected and unfavorable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
A process, where one or more parties within the clinical trial are not aware of the treatment the patients are assigned. Blinding is performed to avoid bias. E.g. if a patient know that he/she is getting the active treatment, this could skew the results, so that it might seem better to get the active drug, than it actually is.
Adherence to all the trial-related requirements. Both considering that the clinic follows the GCP requirements, and the applicable regulatory requirements. Furthermore, compliance can be used in relation to patients adhering to the study schedule.
Case Report Form
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.
Clinic 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.
Double blinded
Two parties are blinded in the clinical trial. Often this is the the patient and the persons performing the trial (monitors) and sometimes even the persons analysing the data from the trial.
Food and Drug Administration
Only relevant in USA. They decide if new medical products can enter the market.
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.
Good Documentation Practice
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. GCP ensures that the data from clinical trials are credible and accurate, making sure that the subjects rights and confidentiality is protected.
In general terms also known as "copy drugs", meaning that the drug contains the same active ingredient as the original drug, but the excipients can vary from the original drug. This is the reason for why some patients cannot use generic drugs.
Good Laboratory Practice
A quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality and integrity of chemical (including pharmaceuticals) non clinical safety tests; from physio-chemical properties through acute chronic toxicity tests.
Good Manufacturing Practice
The GMP guidelines provide the minimum requirements which a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch for their intended user. The requirements for the GMP might vary in relation to the different industry (e.g. food, cosmetics, pharmaceutical products and medical devices). The main purpose of GMP is to avoid that harm is done to the end user.
Investigators Brochure
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.
International Conference on Harmonisation
A regulatory/industry project to improve the efficiency of the process for developing and registering new products in Europe, Japan and USA.
Independent Ethics Committee
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, 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 as described in this guideline.
In vitro
Test made on cultures and in an artificial enviroment - not tested in humans, more like tested in petri dishes at the lab.
In vivo
Test made in living animals and/or human systems.
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
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 subject.
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.
Over The Counter drugs
Drugs that you can buy without having a prescription e.g. painkillers etc.
Principle investigator
The person(s) in charge of a clinical trial or a scientific research grant. The principal investigator prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant. The principal investigator also analyzes the data and reports the results of the trial or grant research.
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 Good clinical Practice (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.
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
Serious Adverse Event
A SAE in human drug trials is defined as any untoward medial occurence that any dose; results in death, is life-threatening, requres inpatient hospitalization or causes prolongation of existing hospitalization , results in persistent or significant disability/incapacity, is a congenital anomality/birth defact, or requires intervention to prevent permanent impairment or damage.
Single 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), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). Often, at a single blinded trial, it is the patient who does not know which medication they recieve.
Site / Clinic
The site is were the patient participate in the clinical trial. This is were all data is collected e.g. Blood samples, CT scan, X-ray etc.
Site Management Organisation
Organisation thats finds and manage performing of clinical sites.
Standard Operating Procedure
Detailed, written intructions to achieve uniformity of the performance of a specific function.
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
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 coroperation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
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 make important trial-related decisions (e.g. associates, residents, research fellows).
Therapeutical Area
A knowledge field that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. The different TA's Patiro has are e.g. cardiovascular disease, endocrine/hormonal diseases etc.
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information.
Vulnerable subjects
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or a retaliatory response from senior members of a hierachy in case of refusal to participate. Examples are members of a group with a hierarchial 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.
Orphan diseases
An orphan disease is a disease which has not been "adopted" by the pharmaceutical industry. Meaning that no treatment has been developed, often due to the fact that it provides little financial incentive for the privat sector to make and market new medications to prevent it.
Rare diseases
A rare disease affects a small percentage of the population. However, there is not single widely accepted definition for rare diseases, so a specific cutoff has not been established. Often, the rare disease is genetic and many rare diseases appear early in life, and about 30 % of children with rare diseases will die before reaching 5 years of age.
A branch of medicine involving medical care of infants, children and adolescents. Pediatrics means "healer of children".
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