Accredited Research Ethics Committee
A Research Ethics Committee (REC) recognised by the United Kingdom Ethics Committee Authority (UKECA) to review the appropriate type of CTIMP under the Medicines for Human Use (Clinical Trials) Regulations 2004 and accredited by NRES.  A list of all recognised and accredited RECs is available on the NRES website.

Adverse Event (AE)
An adverse event is any undesirable occurrence on a particular study.  For clinical trials of investigational medicinal products (CTIMP's) adverse events is defined by ICH GCP as any unfavourable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to that product.

Adverse Reaction

Any untoward and unintended response in a subject to an investigational medicinal product which is related to any dose administered to that subject.

Amendment
A change made to the terms of the Research Ethics Committee (REC) application, the protocol or any supporting documentation after the study has started.  A study is normally considered to start after the commencement of any protocol procedures.  Amendments can be 'substantial' or 'non-substantial'.

Archiving
The retention of study files which demonstrate the compliance of the investigator and sponsor with GCP and regulatory requirements; or the retention of valuable research data which may have secondary use or may be analysed further as part of a meta study.

ATC

The Anatomical Therapeutic Chemical (ATC) classification system divides medicines into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutic properties.  Medicines are classified in groups at five different levels. The medicines are divided into fourteen main groups (1st level), with one pharmacological/therapeutic subgroup (2nd level). The 3rd and 4th levels are chemical/pharmacological/therapeutic subgroups and the 5th level is the chemical substance. The 2nd, 3rd and 4th levels are often used to identify pharmacological subgroups when that is considered more appropriate than therapeutic or chemical subgroups.  The complete classification of metformin illustrates the structure of the code:

A

Alimentary tract and metabolism

(1st level, anatomical main group)

A10

Drugs used in diabetes

(2nd level, therapeutic subgroup)

A10B

Blood glucose lowering drugs, excl. insulins

(3rd level, pharmacological subgroup)

A10BA

Biguanides

(4th level, chemical subgroup)

A10BA02  

Metformin

(5th level, chemical substance)

Thus, in the ATC system all plain metformin preparations are given the code A10BA02.

CAS

CAS (Chemical Abstracts Service) is a division of the American Chemical Society.   CAS Registry Numbers (often referred to as CAS RNs or CAS Numbers) are unique identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides an unambiguous way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary, or trivial names.  CAS Registry Numbers are used in many other public and private databases as well as chemical inventory listings and, of course, are included in all CAS-produced databases. CAS is the largest and most current database of chemical substance information in the world containing more than 23 million organic and inorganic substances and 41 million sequences.

Chief investigator (CI)
The authorised health care professional, whether or not he is an investigator at any particular site, who takes primary responsibility for the conduct of the trial in relation to a clinical trial conducted at a single site or at more than one site.  In relation to a clinical trial of an investigational medicinal product, CI has specific, defined responsibilities.

Clinical Trial
Any investigation in human subjects, other than a non-interventional trial, intended  (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products, (b) to identify any adverse reactions to one or more such products, or (c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products.  A clinical trial of an investigational medicinal product (CTIMP) is a legal definition and describes those trials which fall within the scope of The Medicines for Human Use (Clinical Trials) Regulations (2004).

ClinicalTrials.gov

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. Provides information about a trial's purpose, who may participate, locations, and phone numbers for more details.

Clinical Trials Regulations
The Medicines for Human Use (Clinical Trials) Regulations (2004) is the law within the UK that applies to research into the safety and/or efficacy of investigational medicinal products.  These Regulations are how the EU Clinical Trials Directive was transposed into UK legislation.

Competent Authority (CA)
An organisation (usually a governmental body) that has a statutory role to ensure compliance with relevant current legislation.  This can involve licensing specific activities, performing inspections, granting approvals and/or developing codes of practice.

Consent
The voluntary agreement of an adult or competent child, based on adequate knowledge and understanding of the relevant information, to participate in research.  Consent is often recorded by a signature on a consent form.

Consent Form
A written record of the study participant's decision to take part in the research study.

CRF
Clinical Record Form/Case Report Form.

CTA
Clinical Trial Authorisation - statutory approval from the Competent Authority for a Clinical Trial of an Investigational Medicinal Product.

CTIMP
Clinical Trial of an Investigational Medicinal Product, i.e. a clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.

EMEA
European Medicines Agency (EMEA) is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing authorisation application to the EMEA, which cover the whole of the European Economic Area.  Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use across the European Economic Area.

ERIC
Ethics Research Information Catalogue is a UK Based collection of articles related to the ethics of medical research on humans, provided for researchers or members of research ethics committees to help them consider ethical issues during the development or ethical review of a research proposal.

EudraCT
The European Clinical Trials database (EudraCT) is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC and allows sponsors access to the EudraCT application in order to obtain a EudraCT number, and to complete, save, and print a pdf version of the clinical trial application form.

Exclusion Criteria
Specific criteria which are defined within the study protocol that expressly exclude specific individuals from participating in a study.  The reasons for considering exclusion can range from safety issues, potential difficulties in management of particular participants or the need to control variables within the study.  Exclusion criteria must always be defended ethically to guard against discrimination and uphold the concept of justice (or words to that effect).

Expedited Reporting
Reporting in a specified period of time: e.g. the reporting of SUSARs on CTIMPs.

FDA

The Food and Drug Administration (FDA) is the US government agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the US nation’s food supply, cosmetics, and products that emit radiation.  The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Functional food

A functional food is defined as a foodstuff having health benefits over and above its nutritional value with a health claim on the packaging.

GCP
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.  The objective of the ICH GCP guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.  For CTIMPs, it is a legal requirement that the trial is run to the principles of GCP.

GCP Directive

GCP Directive is the Commission Directive 2005/28/EC of 8 April 2005 which lays down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

Gene Therapy
The deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes.  This includes techniques for delivering synthetic or recombinant nucleic acids into humans and also involves (in the UK definition): genetically modified biological vectors (such as viruses or plasmids), genetically modified stem cells, oncolytic viruses, nucleic acids associated with delivery vehicles, naked nucleic acids antisense techniques (for example, gene silencing, gene correction or gene modification), genetic vaccines, DNA or RNA technologies such as RNA interference and xenotransplantation of animal cells (but not solid organs).

GMP
Good Manufacturing Practice is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification.  GMP is concerned with both production and quality control.

GTAC

Gene Therapy Advisory Committee is the ethics committee for CTIMP's of gene therapies (as defined in Gene Therapy, which includes stem cell therapy trials and trials of tissue engineered medicinal products).

ICD
International Classification of Diseases (ICD) is the international standard diagnostic classification for all general epidemiological, many health management purposes and clinical use. These include the analysis of the general health situation of population groups and monitoring of the incidence and prevalence of diseases and other health problems in relation to other variables such as the characteristics and circumstances of the individuals affected, reimbursement, resource allocation, quality and guidelines.  It is used to classify diseases and other health problems recorded on many types of health and vital records including death certificates and health records. In addition to enabling the storage and retrieval of diagnostic information for clinical, epidemiological and quality purposes, these records also provide the basis for the compilation of national mortality and morbidity statistics by WHO Member States.

ICH
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.  ICH aims to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

Inclusion Criteria
Specific criteria (e.g. age, sex, medical history, the type and stage of a disease) which are defined within the study protocol that identify the specific population group that the researcher wishes to participate in a study.

Inspection
Inspection is a statutory activity, undertaken by government agencies (competent or those acting on their behalf).  It is a systematic investigation into systems and processes to measure compliance with legal frameworks.

Investigational Medicinal Product (IMP)
Investigational Medicinal Product is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial.  This includes products already with a marketing authorisation: when used or assembled (formulated or packaged) in a way different from the authorised form, when used for an unauthorised indication, or when used to gain further information about the authorised form.

Investigational Medicinal Product Dossier

The dossier relating to an investigational medicinal product which accompanies a request for authorisation to conduct a trial in which that product is or is to be used.

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Investigator

The authorised health professional responsible for the conduct of a clinical trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team.

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Investigator's Brochure

A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects.

IRAS
Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals required for health and social care / community care research in the UK.

ISRCTN
The International Standard Randomised Controlled Trial Number (ISRCTN) is a simple numeric system for the unique identification of randomised controlled trials worldwide. The ISRCTN Register also accepts registration of other forms of studies designed to assess the efficacy of health-care interventions. A protocol number is required on each protocol, it is recommended that an ISRCTN number is used for this purpose.

Medicinal Product
Article 1 of Directive 2001/83/EC as amended defines a "medicinal product" as "Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis".

Medicines for Human Use (Clinical Trials) Regulations
The Medicines for Human Use (Clinical Trials) Regulations (2004) apply to research into the safety and/or efficacy of investigational medicinal products.

MedDRA

Medical Dictionary for Regulatory Activities (MedDRA) a pragmatic, medically valid terminology with an emphasis on ease of use for data entry, retrieval, analysis, and display, as well as a suitable balance between sensitivity and specificity within the regulatory environment. It was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee.

MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.  Underpinning the MHRA's work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.  MHRA has statutory powers regarding the approval of medicines / devices for license, approving CTIMPs under the clinical trials regulations and approval for medical device trials.

Monitoring
Monitoring is built into the conduct of the study as a means to minimise risk, and performed by members of the research team and people independent to it.  The process of monitoring a study ensures that the rights and well being of any participants are protected, the reported data are accurate, complete, and verifiable from source documents, and that the conduct of the study is in compliance with the approved protocol/amendments, with GCP, and with the applicable regulatory requirements.

NRES

The National Research Ethics Service (NRES) is a directorate within the UK’s National Patient Safety Agency and provides help and leadership for Research Ethics Committee's (RECs): formerly COREC (Central Office for Research Ethics Committees).

Participant/ Patient Information Sheet (PIS)
The participant information sheet, in a form appropriate for the study population, explains what the research involves and how the research study will affect the participant.  It is usually accompanied by a consent form.

Phase I
A clinical trial to study the pharmacology of an investigational medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.  Phase I trials involve only small numbers of subjects.  The tests are usually carried out on healthy volunteers who may be paid.

PIAG
The Patient Information Advisory Group in the UK was established to provide advice on the use of patient information, and reviews research projects that propose to use identifiable personal information without consent in England and Wales as permitted in law under Section 60 of the Health and Social Care Act 2001.  Its membership is drawn from patient groups, healthcare professionals and regulatory bodies.

Protocol
A research protocol is a written document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial.

Quality Assurance (QA)

A planned and systematic pattern of all actions necessary to provide adequate confidence that the research data output collected was done so consistently and in accordance with established methods.

REC
Research Ethics Committees are independent committees that review the ethical issues within research projects that involve people as participants or their data or tissues. Research Ethics Committees (REC) are established throughout the UK within the NHS as well as independent Phase 1 committees.

Serious Adverse Event (SAE) or Reaction (SAR)
A serious adverse event is an untoward occurrence that (a) results in death, (b) is life-threatening, (c) requires hospitalisation or prolongation of existing hospitalisation, (d) results in persistent or significant disability or incapacity, or (e) consists of a congenital anomaly or birth defect.

Sponsor
The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study.  Responsibilities are defined by the Research Governance Frameworks and by the Clinical Trial Regulations.

SSA
Site Specific Assessment

Suspected Unexpected Serious Adverse Reaction (SUSAR)
All suspected adverse reactions related to an investigational medicinal product (the tested investigational medicinal products and comparators) which occur in the concerned trial, and that are both unexpected and serious.

Unexpected Adverse Reaction

An adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out - (a) in the case of a product with a marketing authorization, in the summary of product characteristics for that product, (b) in the case of any other investigational medicinal product, in the investigator's brochure relating to the trial in question.