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  • Administration of Radioactive Substances Advisory Committee (ARSAC)

    Administration of Radioactive Substances Advisory Committee advises the Health Departments on written applications from practitioners for certificates which will enable them to use specific radioactive medicinal products in diagnosis, therapy or research.

  • Admixed embryo

    Embryos produced by somatic cell nuclear transfer: involving the transfer of human nuclei into empty animal egg cells.  The production of human admixed embryos is regulated by the Human Fertilisation and Embryology Authority.

  • Adult stem cells

    Formed from embryonic stem cells they are partially specialized so that they retain the ability to generate a limited number of cell types, but can no longer make all of the different cells in the body.  They replace and replenish cells that are continually lost by depletion or damage e.g. bone marrow, blood, eye, brain and skeletal muscle. Adult stem cells are found in adults, children, babies and the umbilical cord.

  • Advanced therapy medicinal product (ATMP)

    Advanced therapy medicinal products: include gene therapy, stem cell therapy and tissue engineered products (containing some viable cells) exhibiting medicinal function.

  • 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. For other research that does not use investigational products, it may be any unfavourable and unintended sign, symptom or disease temporally associated with participation in the research project.  The term has also been used to describe unfortunate events that may have serious consequences for the research project, e.g. breaking down of a freezer and loss of tissue samples. Alternative terms: Adverse Outcome, Adverse Incident.

  • 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.

  • Audit

    A systematic and independent examination of study related activities and documents, to determine whether the evaluated study-related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor's standard operating procedures (SOP's), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

  • Autonomy

    An ethical concept describing an individual's freedom to make decisions and choices that affect them and the lives they lead.

  • Chief investigator (CI)

    The Investigator with overall responsibility for the research. In a multi-site study the CI has co-coordinating responsibility for research at all sites. In relation to a clinical trial of an investigational medicinal product, CI has specific, defined responsibilities.

  • Clinical Record Form/Case Report Form (CRF)

    Clinical Record Form/Case Report Form, also used in a different context to mean Clinical Research Facility.

  • Clinical Trial

    Clinical trial is commonly used in the academic sector to refer to any prospective evaluation of a health care intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle (e.g. dietary) advice.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.

  • Clinical Trial Authorisation (CTA)

    Clinical Trial Authorisation - statutory approval from the MHRA for a Clinical Trial of an Investigational Medicinal Product.Is also used to describe a Clinical Trial Agreement: a legal agreement drawn up between parties to define roles and responsibilities in the initiation, conduct and management of a clinical trial.

  • Clinical Trial of an Investigational Medicinal Product (CTIMP)

    A Clinical Trial of an Investigational Medicinal Product or CTIMP is a clinical trial that falls within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. The European Commission have developed an algorithm to enable you to determine whether or not your study falls within the scope of the regulations (available from the Clinical Trials Toolkit)

  • 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. Further information can be found in the Clinical Trials Toolkit.

  • Competence

    The ability of a person, given the necessary information, to understand the nature and the consequences of the proposed procedure or treatment, and to use that information to make a valid choice in accordance with their own fundamental values.In relation to research this would be the ability to understand the research project and their proposed role with in that project and to make a decision as to whether they would like to participate or not based on this information.

  • 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. A template is available on the NRES website.

  • Direct Costs

    Direct costs are those associated with equipment, personnel, travel, and other expenses necessary to carry out a research application.Directly Incurred Costs: costs that are explicitly identifiable as arising from the conduct of a project, are charged as the cash value actually spent and are supported by an audit record.Directly Allocated Costs: the costs of resources used by a project that are shared by other activities. They are charged to projects on the basis of estimates rather than actual costs and do not represent actual costs on a project-by-project basis.

  • Embryonic stem cells

    Stem cells derived from embryos developed as a consequence of IVF treatment, somatic cell transfer or inducing pluripotency in adult cells.  Embryos at the 8 cell stage of development are totipotent (i.e. have to potential to develop into all 216 different cell types that make up the human body).  However older embryos (50-100 cell blastocysts) are pluripotent (i.e. able to specialize into almost all the different types of cell needed to form the human body, but not placenta nor umbilical cord cells and so cannot develop into a complete embryo themselves).

  • European Commission (EC)

    European Commission

  • European Medicines Agency (EMA)

    The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

  • 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

  • Experimental Medicine (EM)

    Investigations undertaken in humans, relating where appropriate to model systems, to identify mechanisms of pathophysiology or disease, or to demonstrate proof-of-concept evidence of the validity and importance of new discoveries or treatments.

  • Food and Drug Administration (FDA)

    Food and Drug Administration is the competent authority for the regulation of food and drugs in the United States of America

  • Fraud

    The fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting results of research or deliberate, dangerous or negligent deviations from accepted practices in carrying out research.  It does not include honest error or honest differences in the design, execution, interpretation or judgement in evaluating research methods or results or misconduct unrelated to the research process.  Similarly it does not include poor research unless this encompasses the intention to deceive.

  • Full Economic Costing (fEC)

    fEC is a governmental system to ensure research institution income covers not only the direct costs of research, teaching, administrative and support services, but also the ongoing investment in maintaining and renewing it's infrastructure (e.g. buildings, equipment and systems).

  • 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 Xenotransplantation of animal cells (but not solid organs).

  • Gene Therapy Advisory Committee (GTAC)

    Gene Therapy Advisory Committee is the UK national research ethics committee for CTIMP's of gene therapies (as defined in regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004). It includes stem cell therapy trials and trials of tissue engineered medicinal products.

  • Good Clinical Practice (GCP)

    Good Clinical Practice (GCP) describes the ethical and scientific quality standard for designing, conducting and reporting trials that involve the participation of human subjects. The International Conference on Harmonisation standardised (ICH) practice across Europe, Japan and the USA. For CTIMPs, it is a legal requirement that the trial is run to the principles of GCP.

  • Good Manufacturing Practice (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.

  • Harm

    That which adversely affects the interests or welfare of an individual. This may be physical harm, discomfort, anxiety, pain, and psychological disturbance or social disadvantage as well as damage to reputation.

  • Hazard

    Anything that could cause harm. Risk assessment requires identification of potential hazards and assessing the likelihood and possible impact of each hazard.

  • Health and Safety

    Health and Safety is a discipline concerned with ensuring that the risks in the changing workplace are properly controlled.  In the UK it is the role of the Health & Safety Executive to inspect, investigate and enforce H & S legislation.

  • Healthy volunteers

    Persons recruited to and consenting to participate in research not by virtue of the fact they are an NHS patient suffering from a specific condition, but rather as they represent normal, non-diseased physiology.

  • HRA

    The Health Research Authority (HRA) was established as a Special Health Authority in 2011 to promote and protect the interests of patients in health research and to streamline the regulation of research. The HRA is responsible for providing the Integrated Research Application System (IRAS) on behalf of the IRAS partners; Research Ethics Committees through the National Research Ethics Service (NRES); the Gene Therapy Advisory Committee (GTAC); and the Confidentiality Advisory Group (CAG).

  • HTA Licence

    The HTA licences premises for the storage of relevant material for research purposes in England, Wales and Northern Ireland. There are many exemptions to the need for an HTA licence for research. The HTA also issues licences for human application in the whole of the UK.

  • Human Fertilisation and Embryology Authority (HFEA)

    The Human Fertilisation and Embryology Authority is the UK's independent regulator overseeing safe and appropriate practice in fertility treatment and embryo research.

  • Human Tissue Authority (HTA)

    The Human Tissue Authority is the competent authority for the regulation and use of human tissue e.g. the requirements for consent, licensing and storage of human tissue. For research the HTA has jurisdiction in England, Wales and Northern Ireland. For human application, the HTA has a UK-wide role.

  • ICMJE

    The International Committee of Medical Journal Editors is a group of general medical journal editors whose participants meet annually and fund their work on the Uniform Requirements for Manuscripts. Participating journals and organisations that approve the revised Uniform Requirements for Manuscripts include the British Medical Journal, Journal of the American Medical Association, New England Journal of Medicine and The Medical Journal of Australia.

  • IMP

    Investigational Medicinal Product is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a CTIMP. 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.

  • 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.

  • Indirect Costs

    Non-specific costs charged across all projects based on estimates that are not otherwise included as Directly Allocated Costs. They include the costs of the Research Organisation's administration such as personnel, finance, library and some departmental services.

  • Infrastructure Costs

    The cost of rent, maintenance, electricity, water and other overheads considered in determining the full economic cost of conducting a research 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.

  • Integrated Research Application System (IRAS)

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

  • Intellectual Property (IP)

    Intellectual property is the novel or previously undescribed tangible output of any intellectual activity. It has an owner, it can be bought,sold or licensed and must be adequately protected. It can include inventions,industrial processes, software, data, written work, designs and images.

  • International Conference on Harmonisation (ICH)

    International Conference on Harmonisation - often used in combination with GCP or Good Clinical Practice (i.e. ICH GCP).

  • International Standard Randomised Controlled Trial Number (ISRCTN)

    The International Standard Randomised Controlled Trial Number 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.

  • IRMER

    Ionising Radiation (Medical Exposure) Regulations 2000 lays down basic measures for the health protection of individuals against dangers of ionising radiation in relation to medical exposure. The Regulations impose duties on those responsible for administering ionising radiation to protect persons undergoing medical exposure whether as part of their own medical diagnosis or treatment or as part of occupational health surveillance, health screening, voluntary participation in research or medico-legal procedures

  • Medical Device

    The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products - many thousands of items used each and every day by healthcare providers and patients.  For more information, see the MHRA devices webpages

  • Medical Research Council (MRC)

    Medical Research Council

  • 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" More information is available from the MHRA Borderline Medicines webpages

  • 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. Further information can be found in CTIMP, IMP and the Clinical Trials Toolkit.

  • MHRA

    The Medicines and Healthcare products Regulatory Agency is the 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. They have statutory powers regarding the approval of drug / devices for license; approving CTIMPs under the clinical trials regulations and approval for medical device trials.

  • Microbial challenge

    The deliberate infection of human volunteers with micro-organisms

  • Minimal risk

    Minimal risk can be defined as either: moderate likelihood of a hazard occurring with minimal impact, or low likelihood of hazard occurring with moderate impact or low likelihood of low impact.

  • Monitoring

    Monitoring should be built into the conduct of the study as a means to minimise risk, and should be ongoing and performed by members of the research team and people independent to it.The process of monitoring a study should ensure that the rights and wellbeing 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.

  • National Institute for Health Research (NIHR)

    National Institute for Health Research

  • NHS Research & Development (R&D) Forum

    The NHS R&D Forum is a network for those involved in planning and managing NHS research in health and social care.

  • NHS Research Ethics Committee (NHS REC)

    NHS Research Ethics Committee

  • NRES

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

  • Parent / guardian

    Describes those with legal responsibility for a child. The Children Act 1989, the Children (Scotland) Act 1995 and the Children (Northern Ireland) Order 1995 set out who has parental responsibility in their respective jurisdictions. The Adoption and Children Act 2002 has extended the definition of those with legal responsibility for the child to include unmarried fathers who have entered into a legally binding Parental Responsibility Agreement.

  • Participant

    A person who takes part in a research study or allows their tissue samples or information to be used in research, following appropriate consent, e.g. a patient or a healthy volunteer.

  • 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. For guidance on preparing appropriate participant information sheets see NRES website.

  • Peer review

    A system whereby research, or research proposals, are reviewed by independent experts to assure the quality of the research (e.g. can the research design answer the question? Does the research add to existing knowledge? etc).

  • Personal data

    In the context of the Data Protection Act 1998 personal data comprise information about living people who can be identified from that data, or from combinations of data and other information which the person in control of the data has, or is likely to have in future.This includes written and electronic records, opinions, images, recordings and information obtained from samples, from which the person can be identified.

  • Phase I

    Phase I or Healthy Volunteers studies are often non-placebo controlled, small studies, and the first test of a drug in humans.To establish safe/tolerable levels To establish initial pharacology in humans Usually carried out on volunteers who may be paid

  • Proposal

    A proposal details the scientific and ethical reasons for research and should demonstrate conceptual innovation, methodological rigor and substantive content.

  • Protocol

    A research protocol is a written document demonstrating the necessity and feasibility of a particular study, as well as giving a detailed plan of how the study will be conducted, analysed and disseminated.  In CTIMPs, the protocol should contain specific information (see Clinical Trials Toolkit)

  • Q and S Regulations

    The Human Tissue (Quality and Safety for Human Application) Regulations 2007 were implemented on 5 July 2007 bringing the EU Tissue and Cells Directives (EUTCD) into UK law. 

  • 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.

  • Randomised Controlled Trial (RCT)

    A Randomised Controlled Trial is a scientific procedure in which treatments are allocated to subjects at random, in order to eliminate bias. It is considered the most reliable form of scientific evidence because it ensures that different treatment groups are statistically equivalent.

  • Recognised Research Ethics Committee

    A Research Ethics Committee (REC) recognised by UKECA (UK Ethics Committee Authority) under the Medicines for Human Use (Clinical Trials) Regulations 2004. A list of all recognised RECs is available on the NRES website

  • Regulators

    Organisations that ensure research is conducted in line with the law, e.g. such as the Human Tissue Authority, Medicines and Healthcare products Regulatory Agency.

  • Reproducible

    A reproducible measurement is one that is repeatable, but not necessarily valid.

  • Research & Development (R&D) office or department

    This term is used generically to describe Research and Development offices or departments within either NHS organizations or universities, Meaning the office or department that has responsibility for research governance in that organisation.

  • Research Ethics Committee (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, in particular universities as well as independent Phase 1 committees.

  • Research governance

    Research governance is a term that is first used in the UK Health Departments' Research Governance Frameworks. It is commonly used in a generic way to encompass the Research Governance Framework standards and principles, including all applicable regulatory requirements.

  • Research Governance Frameworks (RGFs)

    The UK Health Departments' Research Governance Frameworks (RGFs) set standards and principles for carrying-out health related or social/community care research in the UK.

  • Research passport

    A streamlined system for issuing honorary research contracts to researchers who do not have a contractual relationship with the NHS in the UK.  The system enables existing pre-engagement checks and assurances from substantial employers to be used by other organisations wishing to issue honorary research contracts to investigators.  More information is available below

  • Risk

    The likelihood of harm being caused by a hazard and its likely impact. The characteristics of risk include both the probability of its occurrence, as well as the magnitude and duration.

  • Risk management

    The process of identifying possible risks associated with a study and planning how to reduce the risk, or contingency plans should the risk occur.

  • Scottish MREC

    The Research Ethics Committee able to give ethical opinions on studies involving adults not able to consent for themselves in Scotland.

  • Screening

    Screening is a process, usually preceded by consent, in which members of a population are tested to identify those individuals who are suitable for inclusion in a study.

  • Serious Adverse Event (SAE)

    A serious adverse event is an untoward occurrence that:results in deathis life-threateningrequires hospitalisation or prolongation of existing hospitalisationresults in persistent or significant disability or incapacityconsists of a congenital anomaly or birth defectis otherwise considered medically significant by the investigator

  • Significance

    There is a difference between statistical and clinical significance. Statistical significance means that a discovered difference between populations could not have occurred by chance alone. Clinical significance is largely a matter of judgement e.g. the difference between populations may be statistically significant but, if the difference isn't worth achieving, not clinically significant. Differences may be found to be statistically significant, but of no clinical significance.

  • Site Specific Assessment (SSA)

    Site Specific Assessment

  • Site Specific Information (SSI)

    Site Specific Information form

  • Source Data Verification (SDV)

    Source data verification (SDV) is a check that the data collected on a research study (e.g. on a CRF or in a database) can be verified by looking at a primary data source (e.g. medical record): checking for consistency and accuracy in transcribing data from one place to another. Auditors will often wish to see SDV documented when the risks involved indicate it should be used.

  • Sponsor

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

  • Stem cells

    Immature cells that have not yet developed into specialized cells.  They are found throughout the human body: in early embryos (embryonic stem cells) and in adulthood.  Stem cells can be considered to be medicinal products or investigational medicinal products, if they are being presented as exerting principally a pharmacological, immunological or metabolic action.

  • Summary of Product Characteristics (SmPC)

    Summary of Product Characteristics (associated with a marketing licence for a drug)

  • Support departments

    Departments, often service departments with the NHS, which provide input into the conduct of a research project by providing a specific service i.e. Pharmacy, as opposed to a collaborating department which provide intellectual input into study design and /or interpretation.

  • 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. For more detailed guidance please see Clinical Trials Tool Kit.

  • Tissue Engineered Products (TEP)

    Tissue engineered products are medicinal products that are composed of human or animal tissue (some of which are viable) that have been ‘engineered' and they are being presented as exerting principally a pharmacological, immunological or metabolic action.  TEPs are a form of Advanced Therapy Medicinal Products and trials of such must be authorized by the MHRA.

  • UK Clinical Research Collaboration (UKCRC)

    The UK Clinical Research Collaboration is a partnership of organisations working to establish the UK as a world leader in clinical research. The UKCRC brings together key organisations in the UK clinical research environment. This includes the main funding bodies, academia, the NHS regulatory bodies, industry and patients.

  • UK Clinical Research Network (UKCRN)

    The UK Clinical Research Network was established to support clinical research and to facilitate the conduct of trials and other well-designed studies across the UK. As part of the UK Clinical Research Collaboration, it works towards the development of a world class infrastructure to support clinical research in the UK.

  • Urgent Safety Measure

    The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of study against any immediate hazard to their health or safety. If such measures are taken, the sponsor shall immediately and in any event no later than 3 days from the date the measures are taken, give written notice to the relevant ethics committee of the measures taken and the circumstances giving rise to those measures

  • Validity

    Validity indicates that a measurement truly reflects the size or extent of a particular parameter.  For data to be ‘truthful' the measurements used must be both valid and reproducible.

  • Version control

    Version control is the management of multiple revisions to the same document. Version control enables us to tell one version of a document from another

  • Xenotransplantation

    Any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live tissues or organs retrieved from animals, or, human body fluids, cells, tissues or organs that have undergone ex-vivo contact with live non-human animal cells, tissues or organs.


Glossary