An active substance (AS), is the substance in a medicine that is responsible for the expected effect of the medicine.
The substance in a medicine product that is responsible for the expected effect of the medicine and is produced by biotechnology.
The substance in a medicine product that is responsible for the expected effect of the medicine and is produced by chemistry.
Subjects aged 12 to less than 18 years.
Subjects aged 18 to 64 years
Advance Therapy Investigational Medicinal Products are medicinal products involving cell or gene therapy or tissue engineering
Any untoward medical occurrence in a patient or Clinical Trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment Ref: DIRECTIVE 2001/20/EC.
Acronym: Advanced Therapy Investigational Medicinal Product
A study comparing in vivo biological exposure to two preparations of a Medicinal Product.
Biotechnology is the application of biological organisms, systems or process to manufacturing of medicinal products
Acronym: Completely Automated Public Turing test to tell Computers and Humans Apart. A CAPTCHA or Captcha is a type of challenge-response test used in computing to ensure that the response is not generated by a computer.
Acronym: Chemical Abstract Services Number
Chemical Abstract Services (CAS) numbers are unique numerical identifiers for chemical elements, compounds, polymers, biological sequences, mixtures and alloys. A service of the American Chemical Society.
Scientific recommendation stated by the CAT (Committee on Advanced Therapies).
Acronym: Chemical/Biological Description.
European conformity (Conformité Européenne) Marking: A mandatory European marking for industrial products including medical devices to indicate conformity with the health and safety requirements set out in European Directive.
Acronym: Committee for Medicinal Products for Human Use.
The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicines for human use.
It was established by Regulation (EC) No 726/2004 and replaced the former Committee for Proprietary Medicinal Products (CPMP).
An eight digit unique numeric code assigned to a MedDRA term The code is non-expressive and is intended to fulfill a data field in various electronic submission types.
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy Ref: DIRECTIVE 2001/20/EC.
An ATIMP (Advanced Therapy Investigational Medicinal Product) involving a medical device.
An investigational or marketed product (i.e active control) or placebo, used as a reference in a Clinical Trial.
A regulatory agency in an EU Member State.
The unit of measurement used for the concentration of the active substance.
In a controlled Clinical Trial, the tested product is compared to a reference treatment. The reference treatment can be, for example, a placebo, a product known to be effective, a surgical procedure, or a different dose of the same product.
Countries where Clinical Trials are planned to be conducted.
Name of the country where the holder was granted the Marketing Authorisation of the actual IMP to be used in the Clinical Trial in the member state concerned by the application.
Acronym: A contract research organization, also called a clinical research organization is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).
Comparison of two or more treatments in which patients are switched to the alternative treatment after a specified period of time.
Acronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved.
Acronym: Clinical Trial Application
Acronym: Central Technical Facility
Acronym: Clinical Trial Information. As distinct from a CTA, CTI refers to Third Country Clinical Trial Information.
The current code in use by the sponsor for an active substance.
A Data Monitoring Committee is a group of independent experts, external to a study assessing the progress, safety data and, if needed critical efficacy endpoints of a clinical study May also be called DSMB (Data Safety Monitoring Board).
This is the date on which the National Competent Authority Decision was made on the Clinical Trial.
This is the date on which the Independent Ethics Committee Opinion was given on the Clinical Trial.
This is the date on which the Clinical Trial is ended in all countries.
Acronym: EudraCT's searchable DataBase.
The physical description of the product (e.g white tablet, solution).
The condition being studied.
The dose-response describes the change in effect caused by differing doses of a Medicinal Product after a certain exposure time This may apply to individuals, or to populations.
A Clinical Trial where the investigators and the subjects included in the Clinical Trial (healthy volunteers or patients) don’t know which treatment is given.
Acronym: European Commission
Acronym: Eudra Common Directory Manager - A user management application managed and maintained by the European Medicines Agency.
Acronym = Electronic Data Capture
Acronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association)
Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.
Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein.
A measure of whether the medicinal product has its intended effect.
Subjects 65 years old or more.
Acronym: European Medicines Agency
European Medicines Agency's number for the decision on the Paediatric Investigation Plan (PIP).
Independent reviewing body that considers and gives an opinion on Clinical Trials involving human subjects A positive opinion is required for each clinical study protocol and site prior to study initiation.
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC.
When registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan.
The European Union Telematics Controlled Terms (EUTCT) System is a Community repository and provider of controlled terms in multiple languages for the ongoing exchange of data between information systems and applications throughout the European Medicines Regulatory Network (EMRN).
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA).
Product's EudraVigilance Code.
Active Substance's EudraVigilance Substance Code.
A medicinal product obtained by extraction, comprising extractive biological/biotechnological products e.g extractive products derived from human blood and plasma, extracts of animal origin, bacterial extracts and toxins as well as extractive products containing herbal and other (active) ingredients.
The first Clinical Trial of an IMP (Investigational Medicinal Product) in human subjects.
The title as specified in the study protocol and other documents submitted as part of the Clinical Trial Application.
The point of contact for further information on the trial (e.g “Clinical Trial Information Desk”).
Acronym: Good Clinical Practice
Product aimed at the transfer of a prophylactic, diagnostic or therapeutic gene to human and its subsequent expression in vivo.
A genetically modified organism (GMO) or genetically engineered organism (GEO) is an organism whose genetic material has been altered using genetic engineering techniques.
Acronym: GNA = Grounds for Non-Acceptance. Usually taking the form of a letter from the NCA to the applicant, providing details of deficiencies or inadequacies in the CTA, which must be addressed before the CT can proceed.
Clinical trial subjects in good health.
Any medicinal product exclusively containing as active ingredients one or more herbal substances or preparations.
Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States A homeopathic medicinal product may contain a number of principles (Directive 2001/83/EC).
Human pharmacology (Phase I) trials are the first stage of testing in human subjects, generally comprising a small group of healthy volunteers This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a medicinal product.
Acronym: Independent Ethics Committee
Independent Ethics Committee opinion on an amendment.
Any medicinal product consisting of vaccines, toxins, serums or allergen products used to produce an immunological response.
Acronym: Investigational Medicinal Product. A pharmaceutical form of an active substance or placebo being tested or used as a reference in a Clinical Trial, including products already with a marketing authorisation but used or assembled in a different way from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.
The whole Clinical Trial when the Clinical Trial is in all countries concerned.
Subjects are unborn infants, still in the womb.
Within the living body (animal/man) A phenomenon that occurs in life, as opposed to in the laboratory ("in vitro").
Subjects are aged 28 days to less than 2 years.
The International Non-proprietary name for an active substance or the name proposed as INN.
A Clinical Trial in which the assignment of the subject to a particular therapeutic strategy is decided in advance by a trial protocol.
A doctor or a person following a profession agreed in the Member State for investigations because of the scientific background and the experience in patient care it requires The investigator is responsible for the conduct of a Clinical Trial at a trial site If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator.
Acronym: Interruptions or Completions (of the Clinical Trial)
International Standard Randomised Controlled Trial Number is used for the identification of Clinical Trials The randomly generated, eight-digit ISRCTN is unique to a registered trial, thereby ensuring that the trial can be simply and unambiguously tracked throughout its lifecycle from initial protocol to results publication.
An individual, company, institution, or organisation authorised to act on behalf of the sponsor of a Clinical Trial When the sponsor is not legally established in the EU, The Legal Representative must be based in the EU or the EEA, which includes Iceland and Norway (Article 15 of Dir 2001/20/EC).
Acronym: Marketing Authorisation
Acronym: Marketing Authorisation Holder. The company named on the Marketing Authorisation for a specific product in a particular country.
The main purpose for which the trial is conducted.
The approval granted by the Regulatory Authority to market a specific product in a particular country.
MedDRA (Medical Dictionary for Regulatory Activities) - is a medical terminology used to classify medical information associated with the use of biopharmaceuticals and other medical products (e.g, medical devices and vaccines).
Key to MedDRA hierarchical levels (highest to lowest) SOC (System Organ Class) HLGT (High Level Group Term) HLT (High Level Term) PT (Preferred Term) LLT (Lower Level Term).
A description of the medical condition being studied in non-medical language.
Description of intended indication for the product under development and object of the trial.
Medicinal Product Dictionary (also known as eXtended EudraVigilance Medicinal Product Dictionary).
A multinational trial is a Clinical Trial conducted in more than one country.
This is where the trial will be conducted in more than one Member State of the European Economic Area.
A trial is conducted in multiple sites in the concerned Member State.
Name of individual, company, institution or organisation.
A shortened title or description of the Clinical Trial.
Acronym: National Competent Authority
Subjects are newborn aged from birth to less than 28 days.
Number of investigator sites in the Member State concerned where the trial will take place.
Number of investigator sites in the European Economic Area where the trial is planned to take place.
Number of investigator sites outside the European Economic Area where the trial is planned to take place.
Number of treatment groups in a randomised Clinical Trial. Most randomised Clinical Trials have two "arms," but some have three "arms", or even more.
Clinical trial includes women subjects who are breastfeeding.
The goal intended to be attained by the Clinical Trial.
A Trial where the investigators and the subjects know which treatment is actually given.
An orphan medicine is a medicinal product that has been developed specifically to treat a rare medical condition medicine A rare disease (affecting fewer than 5 in every 10,000 individuals in the EU or fewer than 200,000 people in the US) Orphan designation may also be granted for a disease not likely to generate sufficient profit to justify Research and Development costs.
Commission Decision number for the orphan Designation.
Other descriptive names for an active substance.
Two or more treatments groups are evaluated concurrently in a Clinical Trial.
Clinical Trial includes subjects who are currently patients affected by a condition.
Acronym: Portable Document Format (PDF) is an open standard for document exchange. The file format created by Adobe Systems in 1993 is used for representing two-dimensional documents in a manner independent of the application software, hardware, and operating system.
A dosage form is the physical form of a dose of medication, such as a capsule or solution.
Pharmacodynamics is the exploration of what the Medicinal Product does to the body.
Pharmacoeconomics refers to the evaluation of the cost and impact on health systems of a medicine or therapy in comparison to other therapy.
Pharmacogenetics is the study of genetic factors that give rise to differing response to medicines.
Pharmacogenomics is the study of genetic variations that influence a response to medicine.
Pharmacokinetics is the exploration of what the body does to a Medicinal Product.
Phase I is the first stage of the clinical development of a medicinal product. It includes the first administration of that product in human subjects. Phase I Clinical Trials include a small number of subjects (up to 30) and frequently involve healthy volunteers, but may also involve patients. They generally have no therapeutic intent and are initial studies of the safety and tolerability of an IMP. They also include pharmacokinetc and sometimes pharmacodynamic studies.
Phase II Clinical Trials are conducted in patients with the intended target disease. They are conducted to investigate the safety and efficacy of an IMP, and to determine the doses to be used in the larger Phase III trials. They usually involve 100-300 people in total.
Phase III Clinical Trials are the large Clinical Trials (several hundred to several thousand subjects) used to determine the safety and efficacy of the IMP. They are usually multicentre and very often multi-country Clinical Trials. It is usually on completion of the Phase III Clinical Trials that a Marketing Authorisation application is made.
These are studies carried out after the Marketing Authorisation has been granted, and are carried out within the terms of the marketing authorisation (therapeutic use and dose) and using the authorised product Post marketing studies to delineate additional information including the medicine's risks, benefits, and optimal use. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
Acronym: Paediatric Investigation Plan. Document upon which the development and authorisation of medicinal products for the paediatric population is based. It is presented by an applicant early during the development of a product to the EMA Paediatric Committee in order to agree a paediatric development plan.
The PIP Addressee is the legal entity that has received the European Medicines Agency's decision on a Paediatric Investigation Plan (PIP).
A placebo is a control product that does not contain an active substance (a dummy treatment) that is given to people taking part in a Clinical Trial.
The number of subjects planned to be enrolled for a Clinical Trial.
A medicinal product derived from human blood or human plasma.
Plans for treatment or care after the subject has ended the participation in the Clinical Trial.
Subjects born before 37 weeks from their conception.
The main result that is measured at the end of a study (e.g, the number of deaths between the treatment group and the control group). The primary endpoint is decided before the study begins and determines the number of patients to be included.
Most important reasons for exclusion of subjects from the Clinical Trial from among the exclusion criteria described in the protocol.
Most important reasons for the inclusion of subjects in the Clinical Trial.
This is a code designated by the sponsor which represents the name routinely used by the sponsor to identify the product in the Clinical Trial documentation.
In the absence of trade name this is the name routinely used by a sponsor to identify the IMP in the Clinical Trial Documentation.
Medical or public health measure taken whose purpose is to prevent a disease. Primary prophylaxis is generally intended to prevent the development of a disease, while secondary prophylaxis is intended to prevent the disease, once contracted by a patient, from worsening.
The anticipated start date for the recruitment of subjects (patients) for a Clinical Trial.
A document that describes the objective(s), design, methodology, statistical considerations and organisation of a Clinical Trial. The term ‘protocol’ refers to the protocol, successive versions of the protocol and protocol amendments.
A radioactive pharmaceutical, nuclide, or other chemical used for diagnostic or therapeutic purposes.
A Clinical Trial in which subjects are assigned to one of the treatment arms according to chance.
A rare disease affects a limited number of patients. The limit accepted in Europe is at most 5 people in 10,000 affected by the disease.
A medicinal product produced using recombinant technology (i.e by recombining genetic material from different cells or organisms).
The path by which the medicine is brought into contact with the body (e.g oral, epidural, intravenous).
The profile of adverse effects
A definition of the general outline of what the Clinical Trial will investigate.
Results that are measured at the end of a study, in addition to the main result (primary endpoint). Secondary endpoints can explore other aspects of the treatment.
A description of the secondary objectives of the trialClinical Trial, as defined by secondary endpoints.
A Clinical Trial where only the subjects (healthy volunteers or patients) included in the Clinical Trial don’t know which treatment they are given, but the investigator does.
A Clinical Trial is conducted in a single centre (Clinical Trial site) in the country concerned by the application.
Means the use of autologous (emanating from the patient himself), allogeneic (coming from another human being) or xenogeneic (coming from animals) somatic living cells, the biological characteristics of which have been substantially altered as a result of their manipulation to obtain a therapeutic, diagnostic or preventive effect.
Organisation providing monetary or material support for the conduct of the Clinical Trial.
Formulation specifically developed for paediatric use.
Clinical Trial includes subjects (healthy volunteers or patients), who are considered to be part of a population at risk due to their vulnerability (e.g. age, disease state, poverty, hierarchical relationship, institutionalisation).
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a Clinical Trial.
Country name of the organisation or individual sponsoring the Clinical Trial.
Unique Identifier number for the Protocol assigned by the sponsor.
Indication of whether the sponsor is commercial or non-commercial.
A person participating in a Clinical Trial - the subject may be a patient or a healthy volunteer.
Subjects who are legally incapable of giving consent personally to be enrolled in the Clinical Trial. For example: minors or mentally impaired subjects.
This is the product information document which is made available to all prescribing physicians in the EU for marketed products.
Acronym: Suspected Unexpected Serious Adverse Reaction(s).
A third country is a country outside of the European Union/European Economic Area.
A product that contains or consists of engineered cells or tissues, is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue.
Title of the Clinical Trial in non-technical terms, suitable for comprehension by individuals without medical/pharmaceutical training.
Name under which the medicinal product with a marketing authorisation is sold.
A sub-study, or ancillary study, is a study performed on a sub-group of the subjects included in the Clinical Trial. For example, a pharmacokinetics or pharmacogenetics sub-study may include a sample of the patients participating in the Clinical Trial.
A study is described in the Decision on a Paediatric Investigation Plan.
The Clinical Trial phase (Phase I, II, III or IV).
ClinicalTrials.gov registry number. National Clinical Trial numbers assigned in the USA are eight digits, ascending and correlated with registration date.
The version of MedDRA (Medical Dictionary for Regulatory Activities) used to assign a term.
World Health Organisation Universal Trial Reference Number is obtained by the Clinical Trial's sponsor or principal investigator from WHO.
Clinical Trial includes female subjects who have the potential (age) to become pregnant and are not using contraception.
Clinical Trial includes female subjects who have the potential (age) to become pregnant but are using contraception.
eXtended EudraVigilance Medicinal Product Dictionary.
Acronym: eXtensible Markup Language