This jargon buster or glossary of words contains the definitions of some of the terms commonly used in public involvement in research. It is not a complete list of all the words you might come across. The original definitions were developed for INVOLVE by TwoCan Associates working in consultation with a panel of researchers and a panel of people who use services, and we add to them continually.
The jargon buster can be searched by clicking on one of the letters below or browsing all terms.
Association of the British Pharmaceutical Industry: A trade association for UK pharmaceutical companies
This is a brief summary of a research study and its results. It should tell you why the study was done, how the researchers went about it and what they found.
Academic Clinical Fellowships
Action research is used to bring about improvement or practical change. A group of people who know about a problem work together to develop an idea about how it might be resolved. They then go and test this idea. The people who take part in the testing provide feedback on their experiences. They may also identify further actions that need to be researched and tested. This cycle of developing solutions and testing them is repeated until the problem has been solved.
Administration of Radioactive Substances Advisory Committee (ARSAC)
The committee that 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.
An ARSAC research certificate is obtained for all trials which result in radiation exposure to subjects additional to that involved in their routine diagnostic or therapeutic management.
Adverse Drug Reaction (also known as AR)
Advanced Therapy Investigational Medicinal Products (ATIMP)
Means an ATMP as defined in Article 2(1) of Regulation 1394/2007 which is tested or used in a clinical trial (in accordance with Article 2(d) of Directive 2001/20/EC).
Advanced Therapy Medicinal Products (ATMP)
Means any of the following medicinal products for human use:
- a gene therapy medicinal product
- a somatic cell therapy medicinal product
- a tissue engineered product.
As defined in Article 2(1) of Regulation 1394/2007.
An unfavourable outcome that occurs during or after the use of a drug or other intervention, but is not necessarily caused by it.
Adverse Reaction (AR)
Any untoward and unintended response to an investigational medicinal product related to any dose administered.
Comment: All adverse events judged by either the reporting investigator or the sponsor as having a reasonable causal relationship to a medicinal product would qualify as adverse reactions. The expression ‘reasonable causal relationship’ means to convey, in general, that there is evidence or argument to suggest a causal relationship.
Advisory group (steering group)
Many research projects have an advisory group (or steering group). The group helps to develop, support, advise and monitor the project. The group often includes people who use services, carers, researchers and other health and social care professionals, who can provide relevant advice.
Allied Health Professionals
A technique used to prevent selection bias by concealing the allocation sequence from those assigning participants to intervention groups, until the moment of assignment. Allocation concealment prevents researchers from (unconsciously or otherwise) influencing which participants are assigned to a given intervention group.
A written description of a change or formal clarification. Substantial amendments (See below under ‘Substantial Amendment’) to protocol, participant information/consent require REC, R&D, MHRA approval, Non-substantial amendments should be ‘notified’ to REC, R&D, MHRA
Association of Medical Research Charities
Academy of Medical Sciences
Analysis (data analysis)
Data analysis involves examining and processing research data, in order to answer the questions that the project is trying to address. It involves identifying patterns and drawing out the main themes, and is often done with specialist computer software.
Refers to a group of participants allocated to a particular treatment. In a randomised controlled trial, allocation to different arms is determined by the randomisation procedure. Many controlled trials have two arms, a group of participants assigned to an experimental intervention (sometimes called the treatment arm) and a group of participants assigned to a control (the control arm). Trials may have more than two arms.
Administration of Radioactive Substances Advisory Committee: Research studies wishing to administer radioactive medicinal products to human subjects need to obtain ARSAC approval before NHS R&D approval
Annual Safety Report: For studies involving the use of an Investigational Medicinal Product, this is the annual report which must be submitted to the MHRA detailing all SUSARs and SARs that have occurred in subjects on that study in the past year
Advanced Therapy Medicinal Products
The loss of participants during the course of a study. Also called ‘loss to follow up’.
An audit of health or social care involves carrying out a systematic assessment of how well that care is being delivered. Current policy and practice is compared with an agreed standard, so that any problem areas can be identified and improved. Later, the audit can be carried out again to check that the changes made have actually made a difference.
Authorised Health Professional (AHP)
In relation to the Chief of Principal investigator in a CTIMP; a registered doctor, dentist, nurse or pharmacist. This definition does not apply for research other than CTIMPs.
Basic research aims to improve knowledge and understanding, rather than finding a solution to a practical problem. It usually involves work in a laboratory – for example to find a gene linked to a disease or to understand how cancer cells grow. This kind of research can sometimes provide clues as to which avenues to explore to develop new treatments.
Bio Industry Association
A systematic error or deviation in results or inferences from the truth. In studies of the effects of health care, the main types of bias arise from systematic differences in the groups that are compared (selection bias), the care that is provided, exposure to other factors apart from the intervention of interest (performance bias), withdrawals or exclusions of people entered into a study (attrition bias) or how outcomes are assessed (detection bias). Reviews of studies may also be affected by reporting bias, where a biased subset of all the relevant data is available.
The process of preventing those involved in a trial from knowing which comparison group a participant belongs to. The risk of bias is minimised when fewer people know who is receiving the experimental intervention or the control intervention. Participants, caregivers, outcome assessors, and analysts are all candidates for being blinded. Blinding of certain groups is not always possible, for example, surgeons in surgical trials.
A website or web page that contains information or promotes discussion and consists of discrete entries (also called posts) written over a period of time. The most recent post usually appears first.
A carer is a relative, friend or partner who provides (or intends to provide, or used to provide) a substantial amount of care to another person on a regular basis, but not necessarily through living with them.
Case Report Form (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 Academic Training Programme
Comprehensive Clinical Research Network
Consent Form (also ICF, Informed Consent Form)
Code of Federal Regulations (US)
Chief Investigator (CI)
In the case of a CTIMP:
- In relation to a clinical trial conducted at a single trial site, the Investigator for that site; or
- In relation to a clinical trial conducted at more than one trial site, the authorised health professional, whether or not he is an Investigator at any particular site, who takes primary responsibility for the conduct of the trial.
For research other than CTIMPs:
The person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design conduct and reporting of the study whether or not that person is an Investigator at any particular site.
Collaborations for Leadership in Applied Health Research and Care
A systematically developed statement for practitioners and participants about appropriate health care for specific clinical circumstances.
Clinical research aims to find out the causes of human illness and how it can be treated or prevented. This type of research is based on examining and observing people with different conditions and sometimes comparing them with healthy people. It can also involve research on samples of blood or other tissues, or tests such as scans or X-rays. Clinical researchers will also sometimes analyse the information in patient records, or the data from health and lifestyle surveys.
Clinical trial (trial)
Clinical trials are research studies involving people who use services, which compare a new or different type of treatment with the best treatment currently available. They test whether the new or different treatment is safe, effective and any better than what already exists. No matter how promising a new treatment may appear during tests in a laboratory, it must go through clinical trials before its benefits and risks can really be known.
Clinical Trial Authorisation (CTA)
Authorisation by a competent authority (MHRA in the UK) to conduct a clinical trial.
Clinical Trial Certificate (CTC)
Pre-2004 Clinical Trial Arrangements: former method for approval of a clinical trial by the MHRA, now replaced by the Clinical Trials Authorisation.
Clinical Trial Notification Scheme
For for certain ‘Type A’ trials notification of the trial to the MHRA is possible.
Type A trials are those involving medicinal products licensed in any EU Member State if:
- they relate to the licensed range of indications, dosage and form; or
- they involve off-label use (such as in paediatrics and oncology, etc) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.
See the MHRA website for further information.
Clinical Trial of an Investigational Medicinal Product (CTIMP)
A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.
An investigation in human subjects, other than a non-interventional trial, intended:
a) to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products,
b) to identify any adverse reactions, or
c) to study absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products.
Clinical Trials Exemption (CTX)
Pre-2004 Clinical Trial Arrangements: former method for the approval of a clinical trial by the MHRA now replaced by the Clinical Trial Authorisation.
Clinical Trials Regulations (also known as the UK Regulations or the Regulations)
A term used to describe The Medicines for Human Use (Clinical Trials) Regulations (SI 2004 1031) and its amendments.
A brief description of each of the statutory instruments and their relationship with the European Directives can be accessed here.
Closed Facebook group
When a Facebook group is closed, only those who have been invited into a group can see the content and information shared within it. Others will still be able to see that the group exists and who its members are, but they will not be able to see any posts or information within the closed group unless they are invited. Only the creator of the group and anyone they make an administrator has the power to invite someone to a group. For more information see http://facebook.about.com/od/ PagesGroups/ss/Everything-You-Need-To-Know-AboutFacebook-Groups.htm
Comprehensive Local Research Network: CLRNs are the primary vehicle for providing infrastructure to support study involvement at local NHS Trusts. There are 25 in England.
Cluster randomised trial
A trial where clusters of individuals (e.g. clinics, families, geographical areas), rather than individuals themselves, are randomised to different arms.
Where two or more organisations share a significant interest in a study, they may elect to act as co-sponsors.
See Sponsorship Principles (pdf, 103.44 KB) document for further details
The Cochrane Collaboration is an international, non-profit, independent organisation. It ensures that up-to-date and accurate information about the effects of healthcare interventions is readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions, and promotes the search for evidence in the form of clinical trials and other studies on the effects of interventions. NIHR funding for Cochrane Collaboration related activities is managed by NETSCC.
An observational study in which a defined group of people (the cohort) is followed over time. The outcomes of people in subsets of this cohort are compared, to examine people who were exposed or not exposed (or exposed at different levels) to a particular intervention or other factor of interest. A prospective cohort study assembles participants and follows them into the future. A retrospective (or historical) cohort study identifies subjects from past records and follows them from the time of those records to the present.
Collaboration involves active, on-going partnership with members of the public in the research process. For example, members of the public might take part in an advisory group for a research project, or collaborate with researchers to design, undertake and/or disseminate the results of a research project.
Calls for proposals based on pre-defined research questions developed to respond to the information needs of decision-makers (typically, but not exclusively, within the NHS).
Calls for proposals based on pre-defined research questions developed to respond to the information needs of decision-makers (typically, but not exclusively, within the NHS).
Commissioned workstreams start with the information needs of decision makers typically, but not exclusively, within the NHS. These are refined and prioritised by experts in the field, and commissioning briefs are then advertised. Applications are assessed for compliance with the commissioning brief, scientific quality, feasibility and value for money. All NETS programmes have commissioned workstreams, as well as ‘researcher-led’ workstreams, except the Systematic Reviews Programme which only has a researcher-led workstream.
A commissioner is the person (or organisation) who asks for a piece of research to be carried out.
Commissioning usually involves:
• identifying funding for a piece of research
• preparing a research brief
• advertising the research topic
• selecting a shortlist of researchers who apply to undertake the research
• arranging for proposals to be peer reviewed
• making a decision about which researchers are going to be awarded the funding
• agreeing a contract.
Commissioning board / commissioning panel
A commissioning board is a group of people who oversee the commissioning process. It is made up of research funders, researchers, health and/or social care professionals and often includes people who use services and carers.
A detailed description of a question to be answered by new research. In responding to a commissioning brief, researchers outline what studies they would undertake to obtain the information required.
Common European Submission Platform (CESP)
Provides a simple and secure mechanism for exchange of information between applicants and regulatory agencies via one platform.
An investigational or marketed product (i.e. active control) or placebo, used as a reference in a clinical trial.
Competent Authority (CA)
Each member state in the European Economic Area has appointed a competent authority to perform certain functions required by Directive (2001/20/EC). The MHRA (the UK’s licensing authority established under the Medicines Act 1968) is the competent authority in the UK.
A measure of the uncertainty around the main finding of a statistical analysis. Wider intervals indicate lower precision and narrow intervals indicate greater precision.
During a research project, the researchers must put data protection measures into place, to ensure that all of the information collected about the participants is kept confidential. This means that the researchers must get the participants’ written permission to look at their medical or social care records. It also means that any information that might identify the participants cannot be used or passed on to others, without first getting the participants’ consent. For example, when researchers publish the results of a project, they are not allowed to include people’s names.
This confidentiality will only be broken in extreme circumstances: where it is essential for the person’s care, treatment or safety, where it is required by a court order, for example in a criminal investigation, or where it is necessary to protect the public.
A factor that is associated with both an intervention and the outcome of interest. For example, if people in the experimental group of a controlled trial are younger than those in the control group, it will be difficult to decide whether a lower risk of death in one group is due to the intervention or the difference in age. Age is then said to be a confounder, or a confounding variable. Randomisation is used to minimise imbalances in confounding variables between experimental and control groups. Confounding is a major concern in non-randomised trials.
Consultation involves asking members of the public for their views about research, and then using those views to inform decision-making. This consultation can be about any aspect of the research process – from identifying topics for research, through to thinking about the implications of the research findings. Having a better understanding of people’s views should lead to better decisions.
The term consumer is used to refer collectively to:
• people who use services
• organisations representing consumers’ interests
• members of the public who are the potential recipients of services
• groups asking for research to promote good health or because they believe they have been exposed to potentially harmful circumstances, products or services.
The unintended application of the intervention being evaluated to people in the control group; or unintended failure to apply the intervention to people assigned to the intervention group.
Contract Research Organisation (CRO) (also known as Clinical Research Organisation)
A service organisation that provides support to the pharmaceutical and biotechnology industries (and other organisations) in the form of research services outsourced on a contract basis.
A participant in the arm that acts as a comparator for one or more experimental interventions. Controls may receive placebo, no treatment, standard treatment, or an active intervention, such as a standard drug.
Control Group / Arm
The groups being compared in the randomised trial.
Also referred to as “study groups”, “treatment groups”, “the arms” of a trial, or by individual terms such as treatment and control groups.
A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a “historical control”).
Coordinated System for gaining NHS Permission (CSP)
The Coordinated System for gaining NHS Permission in England which is:
a) a service to Investigators which facilitates set up and approval for research in the NHS
b) a standardised process by which NHS organisations provide NHS permission for research.
Also sometimes used informally to refer to the information system which supports the process.
Central Office for Research Ethics Committees (replaced in 2007 by NRES)
A measure addressing the cost implications of achieving health benefits. To facilitate comparisons, health benefits can be quantified in terms of ‘QALYs’ (Quality-Adjusted Life Years), which incorporate both extra life achieved and improvements in quality of life. Knowing the cost associated with each QALY gained can help decision-makers assess whether the introduction of a treatment or service should be recommended.
An economic analysis that views effects in terms of overall health specific to the problem, and describes the costs for some additional health gain (e.g. cost per additional stroke prevented).
Care Quality Commission
Clinical Research Associate: usually a commercially employed person supporting the management of clinical studies, helps with obtaining R&D approval, site initiation, study monitoring and close out
Centre for Reviews and Dissemination
Case Report Forms: data collection tools provided by a sponsor on which the clinical data is recorded for each participant, such as weight, lab results, symptoms
Clinical Research Facility: hospital-like facility with consulting rooms, standard patient beds, ward medical equipment, research nurses supporting only research
Clinical Research Facilities for Experimental Medicine
Clinical Research Network
Clinical Research Network Coordination Centre
Clinical Research Organisation or Contract Research Organisation: 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
Clinical Studies Advisory Group
Clinical Studies Group
Coordinated System for gaining NHS Permissions: Standard process for adoption onto NIHR Portfolio of Studies in order to access NIHR CRN Support and funding; streamlines the process for gaining NHS permissions by collating the information for global and local approvals; researchers initiate this in IRAS by completing and submitting CSP Application Form
Clinical Trials Toolkit
Clinical Trials Administrator: person providing coordinating/secretarial support for running clinical studies
Clinical Trials Agreement: contract between the legal Sponsor and the hosting research sites
Clinical Trials Associate (similar to CRA): person involved in the management of a study from initiation, through conduct/monitoring to close-out
Clinical Trials Authorisation: The regulatory approval for a clinical trial of a medicinal product issued by the MHRA
Clinical Trials Advisory and Awards Committee
Clinical Trial Document
Clinical Trials Fellowships
Clinical Trial of an Investigational Medicinal Product
Clinical Trials Units
Diarrhoea and Vomiting
Devices for Dignity Healthcare Technology Cooperative
Database of Abstracts of Reviews of Effects
Data is the information collected through research. It can include written information, numbers, sounds and pictures. It is usually stored on computer, so that it can be analysed, interpreted and then communicated to others, for example in reports, graphs or diagrams.
Data Monitoring Committee (DMC) (also known as DMEC, IDMC, DSMB and ISMC)
A 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.
All personal information is protected in the UK by the Data Protection Act (1998). This means that researchers have to put in all the necessary safeguards to protect the confidentiality of the information they collect about research participants. They should explain in the patient information sheet:
• how the participants’ data will be collected
• how it will be stored securely
• what it will be used for
• who will have access to the data that identifies participants
• how long it will be kept
• how it will be disposed of securely.
A list of appropriately qualified persons to whom the investigator has delegated significant trial related duties.
Sponsors/host organisations will usually provide a template for the Delegation Log and researchers should check with their NHS R&D office if any ‘preferred template’ is available. If no default document is available, the following template may be adapted (pdf, 27.25 KB)
Dementia Translational Research Collaboration
Dementias and Neurodegenerative Diseases Research Network
Development Safety Update Report (DSUR)
The common format for annual safety reports on investigational drugs in the ICH regions under ICH guideline E2F.
Department of Health
This is a definition that has been agreed by the EME, PHR, HTA, RfPB and i4i programmes. A diagnostic test is an indicator or predictor of an illness state. As such, the term needs to be interpreted broadly as it includes diagnostic tests, screening, tests to stage disease, treatment monitoring, and estimate prognosis estimation. There are a number of types of diagnostic study that will be considered by the NIHR:
- The first of these is the development of a new test or instrument and/or the broad assessment of its reliability and validity. These might range from questionnaires that identify mental states to molecular assays. Test development and/or testing for psychometric properties or analytic validity, as it is called in the ACCE framework, are only supported to the extent that the test technology is well-developed and forms part of a clear pathway into further research which directly promotes patient benefit
- Diagnostic accuracy studies examine the clinical validity of a test, i.e. whether the changes in the measure reflect changes in disease state or risk, and usually assess a new test against a gold-standard or reference one. Such studies are likely to report sensitivity and specificity, positive and negative predictive values and Receiver Operating Characteristic (ROC) curve in a defined population
- Diagnostic utility studies examine the value of a diagnostic test in improving patient outcomes and are often designed as trials and powered on relevant clinical endpoints. Economic outcomes may also be important.
Diagnostic tests: Which programme should I apply for?
- Applications can be made to the i4i Programme which funds innovative technologies that offer significant patient benefit. Otherwise, for test development and assessment of test properties, the RfPB Programme is an appropriate funding source if the trajectory into patient benefit is likely to be short.
- Stand-alone studies of diagnostic accuracy are most likely to be submitted to RfPB.
- Studies of diagnostic utility (even if they contain components looking at diagnostic accuracy) should be submitted to the HTA Programme.
- Diagnostic utility studies should be submitted to the EME Programme; if they include studies of mechanisms or promote understanding of pathophysiology.
Database of Individual Patient Experience – the DIPEx website has a range of open source videos of real patient experiences www.healthtalkonline.org
Dissemination involves communicating the findings of a research project to a wide range of people who might find it useful. This can be done through:
• producing reports (often these are made available on the Internet)
• publishing articles in journals or newsletters
• issuing press releases
• giving talks at conferences.
It is also important to feedback the findings of research to research participants.
Doctors and Dentists Exemption (DDX)
Pre-2004 Clinical Trial Arrangements: former method for the approval of a clinical trial by the MHRA now replaced by the Clinical Trial Authorisation.
A trial where the investigators and the subjects included in the trial (healthy volunteers or patients) do not know which interventions / treatments have been assigned.
Doctoral Research Fellowships
Diabetes Research Network
Data and Safety Monitoring Board: An independent committee composed of clinical research experts and community representatives that reviews data whilst a clinical trial is in progress to ensure that participants are not being exposed to undue risk
Experimental Cancer Medicine Centre
Economic analysis (economic evaluation)
Comparison of the relationship between costs and outcomes of alternative healthcare interventions.
A generic term for the estimate of treatment effect for a study.
The extent to which an intervention produces a beneficial result under ideal conditions. Clinical trials that assess efficacy are sometimes called explanatory trials.
The key standards that people who want to participate in a clinical study must meet or the characteristics that they must have. These include inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.
The European Medicines Agency: A body of the European Union which has responsibility for the protection and promotion of public health through the evaluation and supervision of medicines for human use
With emancipatory research, people who use services, rather than professional researchers, have control of the whole research process. They plan and undertake the research, and interpret the findings. The main aim is always to empower people and improve people’s lives. ‘Professional’ researchers may be brought in as advisers or have specified roles within the project.
Efficacy and Mechanism Evaluation, one of the NETS programmes. The EME Programme funds research which aims to establish definitive proof of clinical efficacy. Studies may also include embedded mechanistic studies which will add to our understanding of biological or behavioural mechanisms.
This is the process by which people who use services equip themselves with the knowledge, skills and resources they need to be able to take control over decisions and resources. It often involves people building confidence in their own strengths and abilities. It does not always mean people take control over all decisions or all resources.
Endpoint Adjudication Committees
In clinical studies where endpoints are complex to assess and/or include subjective components or the study cannot be blinded, an Endpoint Adjudication Committee, consisting of clinical experts in a specific clinical area, might be set up to harmonise and standardise endpoint assessment and to determine whether the endpoints meet protocol-specified criteria. In order to allow for an unbiased endpoint assessment the members of such a committee should be blinded to treatment assignment. Endpoint Adjudication Committees are, for example, widely used in the assessment of radiological endpoints.
Where information and knowledge about research is provided and disseminated, for example science festivals, open days, media coverage.
Enabling Research in Care Homes
The act of admitting a participant into a trial. Participants should be enrolled only after study personnel have confirmed that all the eligibility criteria have been met.
Formal enrolment must occur before randomised assignment.
Bowel Function Healthcare Technology Cooperative
The study of population and community health, not just individuals.
Enhancing the Quality and Transparency of Health Research Network
A state of uncertainty where a person believes it is equally likely that either of two treatment options is better.
Essential Documents (EDs)
The essential documents relating to a clinical trial are those which enable both the conduct of the clinical trial and the quality of the data produced to be evaluated; and show whether the trial is, or has been, conducted in accordance with the applicable regulatory requirements.
Ethics are a set of principles that guide researchers who are carrying out research with people. Ethical principles are designed to protect the safety, dignity, rights and well-being of the people taking part. They include the requirement to ask each individual to give their informed consent to take part in a research project.
The job of an ethics committee is to make sure that research carried out respects the dignity, rights, safety and well-being of the people who take part. Increasingly ethics committee approval is needed for health and social care research. Ethics committee members include researchers and health care professionals as well as members of the public.
EU Clinical Trials Register
The website providing the public with information held in the EU clinical trial database, EudraCT. It provides the public with information on clinical trials which have been authorised in the EEA and also those which are part of a PIP (Paediatric Investigation Plan). It gives users the ability to search for information on any paediatric clinical trial and any adult clinical trial recorded in EudraCT.
European Clinical Trials Database: A database of all clinical trails in Europe, held since 1994 in accordance with EU directive 2001/20/EC
EudraVigilance Clinical Trials Module (EVCTM)
Part of the EudraVigilance data processing network and management system to facilitate the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) as required by Directive 2001/20/EC.
European Commission (EC)
The European Commission is the executive body of the European Union, responsible for proposing legislation, implementing decisions, and day-to-day running of the EU.
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.
European Union Drug Regulating Authorities Clinical Trials (EudraCT)
The European Clinical Trials Database of all clinical trials administered by the European Medicines Agency. It is mandatory for sponsors to post clinical trial summary results in EudraCT following the end of a trial.
This involves assessing whether an intervention (for example a treatment, service, project, or programme) is achieving its aims. A project can be evaluated as it goes along or right at the end. An evaluation can measure how well the project is being carried out as well as its impact. The results of evaluations can help with decision-making and planning.
Evaluative research seeks to assess or judge in some way, providing useful information about something which cannot be gleaned by mere observation or investigation of relationships.
An evidence base is a collection of all the research data currently available about a health or social care topic, such as how well a treatment or a service works. This evidence is used by health and social care professionals to make decisions about the services that they provide and what care or treatment to offer people who use services.
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.
This type of research allows researchers to explore cause and effect. For example, experimental research would be used to see whether a new drug is effective in reducing blood pressure. The research design (in this example a randomised controlled trial) will tell the researcher whether any reduction in blood pressure is definitely due to the drug.
Experts by experience
The term ‘experts by experience’ refers to service users and carers, who are experts through their experience of illness or disability and services.
An agreement between an organisation and relevant external parties for example between an organisation and a research organisation. External agreements may be required to confirm issues such as: indemnity, intellectual property, roles and responsibilities, data protection, confidentiality, financial and termination issues, standards of service and where applicable regulatory obligations.
An online social networking service. After registering to use the site, users can create a personal profile, add other users as friends, exchange messages, post status updates and photos, and receive notifications when others update their profiles. Users can also join interest groups, which can be open, closed or secret.
A trial design used to assess the individual contribution of treatments given in combination, as well as any interactive effect they may have. In a trial using a 2×2 factorial design, participants are allocated to one of four possible combinations. This type of study is usually carried out in circumstances where no interaction is likely.
Frequently Asked Questions
A streamlined system used in some NETS programmes under exceptional circumstances to speed up the assessment of proposals.
Food and Drug Administration: the Competent Authority in the United States, giving authorisation to conduct clinical trials and issuing marketing licences
Feasibility and Pilot studies: Which programme should I apply to?
There are a number of NIHR programmes which will fund feasibility and pilot studies. There are no strict rules about which programme funds which feasibility or pilot study and it is for applicants to choose the most appropriate in the context of the guidance on applicability provided by each programme. It may be that it is best suited to the Research for Patient Benefit Programme or one of the five NETS programmes. Nevertheless, in choosing, you might like to consider the following:
- Is the programme appropriate in terms of geography and grant size? (RfPB funding, for example, can only be accessed through English NHS trusts and has a maximum grant size of £250,000.)
- Can a robust case be made for the plausibility of the intervention and clinical importance of any subsequent full trial? If there is good proof of concept and/or efficacy data available and there is a clear plan to explore the intervention further in a large clinical trial, then the HTA or EME programmes might be considered, the latter in particular if there are substantial mechanistic elements and laboratory support involved in the project. On the other hand, if the feasibility or pilot study is for a potential trial which might be viewed as more speculative, with no clear plan for a large trial in the very near future, or in which there seems a high risk that the pilot/feasibility study is likely to demonstrate that a full trial is not possible, then the smaller sums that RfPB provide might be seen as more appropriate.
Note that feasibility and pilot studies should be distinguished from Phase II trials in which some sort of evidence for efficacy, often in a surrogate marker, is sought prior to embarking on a full Phase III trial: EME might be the most appropriate funding stream for these if there is strong scientific interest in the question, and RfPB if there is a clear potential trajectory into patient benefit.
The Public Health Research Programme also funds feasibility and pilot studies within its remit of evaluating public health interventions delivered outside the NHS.
This is a definition that has been agreed by the EME, PHR, HTA and RfPB programmes. Feasibility Studies are pieces of research done before a main study in order to answer the question “Can this study be done?”. They are used to estimate important parameters that are needed to design the main study. For instance:
- standard deviation of the outcome measure, which is needed in some cases to estimate sample size;
- willingness of participants to be randomised;
- willingness of clinicians to recruit participants;
- number of eligible patients, carers or other appropriate participants
- characteristics of the proposed outcome measure and in some cases feasibility studies might involve designing a suitable outcome measure;
- follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs in cluster trials, etc.
- availability of data needed or the usefulness and limitations of a particular database
- time needed to collect and analyse data
A focus group is a small group of people brought together to talk. The purpose is to listen and gather information. It is a good way to find out how people feel or think about an issue, or to come up with possible solutions to problems.
A process of periodic contact with participants enrolled in the trial for the purpose of administering the assigned intervention(s), modifying the course of intervention(s), observing the effects of the intervention(s), or for data collection.
Twitter users may subscribe to other users’ tweets – this is known as ‘following’ and subscribers are known as ‘followers’.
Full and appropriate funding
Full and appropriate funding is provided because no upper limit is placed on the amount of funding granted for a project. Subject to availability of funds, if the question is important enough and the science requires it, we will fund it. For University based projects, we will fund up to 80 per cent of the Full Economic Cost (FEC) of the research, and 100 per cent of the direct costs for NHS Trust based projects. Other organisations are welcome to apply to our programmes and should discuss costing with us.
Organisation providing funding for a study (through agreements, grants or donations to an authorised member of the employing and/ or care organisation). The main funder typically has a key role in scientific quality assurance. In any case, it remains responsible for securing value for money.
A group of experts who consider grant applications and reviewer reports to decide whether to recommend funding.
Governance Arrangements for Research Ethics Committees
Gene Therapy Advisory Committee (GTAC)
The Gene Therapy Advisory Committee is the national ethics committee for clinical trials involving medicinal products for gene therapy under Regulation 14(5).
The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings.
The method, procedure, or measurement that is widely accepted as being the best available, against which new developments should be compared.
Good Clinical Practice (GCP)
Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) 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.
A Google+ page is similar to a Facebook page, in that it enables people to set up profiles, or ‘pages’, to post and share information.
Governance Arrangements for Research Ethics Committees (GAfREC)
A policy document has been written by the UK Health Departments describing what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Department’s responsibility. It also explains when review by these committees is required. It can be downloaded from the Department of Health’s Publications Policy and Guidance web page.
Grey literature is material that is less formal than an article in a peer review journal or a chapter in a book – so it’s not easily tracked down. It includes internal reports, committee minutes, conference papers, factsheets, newsletters and campaigning material. However, ‘grey literature’ may be made available on request and is increasingly available on the Internet.
Gene Therapy Advisory Committee: the ethics committee for clinical studies using genetically modified products; usually no REC approval required
On Twitter, a hashtag (#) is a way to bring together information about a topic. For example you can have a hashtag for a conference or an interest group.
Health Research Authority (HRA)
An NHS organisation established to protect and promote the interests of patients and the public in health research. The National Research Ethics Service (NRES) is now part of the HRA.
Health Technology is an internationally recognised term that covers any method used by those working in health services to promote health, prevent and treat disease and improve rehabilitation and long-term care. “Technologies” in this context are not confined to new drugs or pieces of sophisticated equipment.
Health Education England
Higher Education Institution
Human Fertilisation and Embryological Authority
Health Innovation Challenge Fund
Honorary contracts are required by anyone who wants to carry out research or observe people in an NHS setting, but who does not already have an employment contract or a volunteer contract with the relevant NHS Trust. The contract ensures that they are covered by NHS liability insurance, and that they are contractually bound to take proper account of the NHS duty of care.
Health Research Authority
Honorary Research Contract
Health Services and Delivery Research, one of the NETS programmes. The HS&DR Programme funds research into the quality, access and organisation of health services, including costs and outcomes.
Health Services and Delivery Research Programme
Horizon Scanning Centre
Health Technology Assessment, the HTA Programme produces independent research information about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS.
Human Tissue Act or Human Tissue Authority
Health Technology Assessment – one of the NIHR research funding streams
Hubs for Trials Methodology Research
In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value.
Integrated Academic Training Programme
Informed Consent Form
International Conference on Harmonisation (Europe, USA, Japan): Defined standards for the terminology, design, conduct, monitoring, recording, analysis and reporting of a study. These standards give assurance that the reported results are accurate and credible and that the rights, integrity and confidentiality of all study participants have been protected throughout the study. Section E6 of ICH defines principles of Good Clinical Practice (referred to as ICH-GCP). Research teams on CTIMPs in the UK must follow GCP requirements as detailed in MfHU (CT) Statutory Instruments; all non-CTIMP studies conducted within the NHS adhere to GCP according to Research Governance Framework
Independent Data Monitoring Committee
Investigational Medicinal Product: an unlicensed new drug, or an existing drug tested outside its licence, or existing drugs tested against each other for their efficacy/safety. The MHRA provide an algorithm to establish whether a study is a CTIMP: see Resource 2 or the MHRA website (provided on p67) http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con009394.pdf
Implementation involves putting research findings into practice. This means using research findings to make appropriate decisions and changes to health and social care policy and practice.
An adult unable by virtue of physical or mental incapacity to give informed consent.
Specific criteria which are defined within the study protocol that expressly include specific individuals to participate in a study e.g. individuals within a certain age range, with a specific condition, etc.
Investigational New Drug: sometimes used instead of IMP
Insurance or indemnity includes provision for meeting losses or liabilities—
a) under a scheme established under—
i) section 21 of the National Health Service and Community Care Act 1990 (schemes for meeting losses and liabilities etc. of
certain health service bodies in England and Wales)(d),
ii) section 85B of the National Health Service (Scotland) Act 1978 (schemes for meeting losses and liabilities etc. of certain
health service bodies in Scotland)(e), or
iii) Article 24 of the Health and Personal Social Services (Northern Ireland) Order 1991(schemes for meeting losses and
liabilities etc. of certain health service bodies in Northern Ireland)(f), or
b) in accordance with guidance issued by—
i) the Secretary of State,
ii) the Scottish Ministers,
iii) the National Assembly for Wales, or
iv) the Department for Health, Social Services and Public Safety,
As to the arrangements to be adopted by health service bodies for meeting the costs arising from clinical negligence (known as NHS Indemnity).
Compensation for damage, loss or injury
Informed Consent (IC)
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.
For CTIMPs: A person gives informed consent to take part only if his/her decision:
a) is given freely after that person is informed of the nature, significance, implications and risks of the trial; and
i) is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or
ii) if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.
The act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent 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 contract research organisation’s facilities, or at other establishments which the competent authority sees fit to inspect.
In the UK, the MHRA’s Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA.
Institutional Review Board (IRB)
The generic term used by the Food & Drugs Administration (FDA) in the United States for independent ethics committees that have been formally designated to review and monitor biomedical research involving human subjects.
Integrated Research Application System (IRAS)
The online application system used to apply for most permissions and approvals for research in health and social care in the UK.
Intellectual Property (IP)
IP can be described as the novel or previously undescribed tangible output of any intellectual activity. It has an owner and can be bought, sold or licensed and must be adequately protected. It can include inventions, industrial processes, software, data, written works, designs and images.
The situation in which the effect of one independent variable on the outcome is affected by the value of a second independent variable.
Interactive Response Technologies (IRTs)
Interactive Response Technology (IRT) is software that enables activities such as randomisation into clinical trial and dispensing medications in a blinded trial. Examples include telephone based Interactive Voice Response Systems (IVRS) or internet based, Interactive Web Response Systems (IWRS). These technologies are also used in other trial management activities and the EMA has published a reflection paper with further guidance.
A website that encourages people to interact with it, rather than just offering information or selling products. For example it might invite contributions (e.g. stories, photos, films), comments and blogs; hold online events and discussions; and include open or closed discussion forums.
Analysis comparing intervention groups at any time before the formal completion of a trial, usually before recruitment is complete. Often used with stopping rules so that a trial can be stopped if participants are being put at risk unnecessarily. Timing and frequency of interim analyses should be specified in the protocol.
An analysis comparing intervention groups undertaken at any time before the formal completion of the trial, usually before recruitment is complete.
Often used with “stopping rules” so that a trial can be stopped if participants are being put at risk unnecessarily. Timing and frequency of interim analyses should be specified in the protocol.
An agreement between an organisation and relevant internal parties. Examples include:
- Agreements, memoranda or documentation between a ‘ R&D Office’ and clinical and non-clinical support services in order to facilitate engagement and internal authorisation from named support service leads.
- Agreements between a Principal Investigator / Chief Investigator and support service or stakeholders within an organisation.
- Agreements between the organisation and relevant party for resources who require an honorary research contract or letter of access.
These agreements may be in the form of a standardised document or email format.
International Committee of Medical Journal Editors (ICMJE)
The ICMJE is a group of general medical journal editors whose participants meet annually and fund their work on the Uniform Requirements for Manuscripts.
International Conference on Harmonisation (ICH)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs to establish common standards for clinical trials.
International Standard Randomised Controlled Trial Number (ISRCTN)
A simple numeric system for the unique identification of randomised controlled trials worldwide. The randomly generated number is unique to a registered trial, thereby ensuring that the trial can be simply and unambiguously tracked throughout its lifecycle. The ISRCTN Register also accepts registration of other forms of studies designed to assess the efficacy of health-care interventions.
An intervention is something that aims to make a change and is tested through research. For example, giving a drug, providing a counselling service, improving the environment or giving people information and training are all described as interventions.
A group of participants in a study receiving a particular health care intervention. Parallel group trials include at least two intervention groups.
A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
In research, an interview is a conversation between two or more people, where a researcher asks questions to obtain information from the person (or people) being interviewed. Interviews can be carried out in person (face-to-face) or over the phone.
Investigational Medicinal Product (IMP)
A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a Clinical Trial, and includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial –
a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorisation,
b) used for an indication not included in the summary of product characteristics under the authorisation for that product, or
c) used to gain further information about the form of that product as authorised under the authorisation.
Investigational Medicinal Product Dossier (IMPD)
The IMPD includes summaries of information related to the quality, manufacture and control of any IMP (including reference product and placebo), and data from non-clinical and clinical studies.
Investigator Site File (ISF)
The Investigator Site File contains all essential documents held by Principal Investigator(s) conducting a trial which individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.
Investigator’s Brochure (IB)
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. Guidance on when an Investigator’s Brochure is required can be accessed from the Trial Supplies station.
Involvement in research refers to active involvement between people who use services, carers and researchers, rather than the use of people as participants in research (or as research ‘subjects’). Many people describe involvement as doing research with or by people who use services rather than to, about or for them.
Integrated Research Application System
Independent Review Boards: US equivalent of authorised REC
Ionising Radiation Medical Exposure Regulations: part of NHS R&D approval, usually done by the local hospital experts
Information Systems Programme
Investigator Site File: A file designed for use in organising and collating all essential documentation required to conduct a study in accordance with the principles of GCP and the applicable regulatory requirements (e.g. REC approval letter/correspondence, MHRA approval, blank CRF, staff CVs, delegation of duties log etc.)
International Standard Randomised Control Trial Number: A simple numeric system for the identification of randomised controlled clinical trials worldwide. Allows the identification of trials and provides a unique number that can be used to track all publications and reports resulting from each trial; can be obtained from www.isrctn.org or www.controlledtrials.com/mrct
James Lind Alliance
James Lind Alliance Priority Setting Partnerships
Where two or more organisations share a significant interest in a study, they may elect to act as joint-sponsors.
See Sponsorship Principles (pdf, 103.44 KB) document for further details.
A journal is a regular publication in which researchers formally report the results of their research to people who share a similar interest or experience. Each journal usually specialises in one particular topic area. The British Medical Journal (BMJ), British Journal of Social Work and The Lancet are examples of journals.
Research Knowledge Mobilisation Fellowshipships
Getting the right information to the right people in the right format at the right time, so as to influence decision-making. Knowledge Mobilisation includes dissemination, knowledge transfer and knowledge translation.
Lay (lay person)
The term ‘lay’ means non-professional. In research, it refers to the people who are neither academic researchers nor health or social care professionals.
A lay summary is a brief summary of a research project or a research proposal that has been written for members of the public, rather than researchers or professionals. It should be written in plain English, avoid the use of jargon and explain any technical terms that have to be included.
Legal Representative (in relation to sponsor role)
If the main sponsor of a clinical trial with a medicinal product is not based in the European Economic Area (EEA), for example, an American or Japanese company, it is a statutory requirement to appoint a legal representative based in the EEA for the purposes of the trial.
The legal representative:
- may be an individual person or a representative of a corporate entity
- does not have to be a legally qualified person
- should be willing to act as the agent of the sponsor in the event of any legal proceedings instituted in the EEA (for example, for service of legal documents)
- should be established and contactable at an address in the EEA
- does not assume any of the legal liabilities of the sponsor(s) for the trial by virtue of the role of legal representative and does not therefore require insurance or indemnity to meet such liabilities, but may in some cases enter into specific contractual arrangements to undertake some or all of the statutory duties of the sponsor in relation to the trial, in which case the legal representative would also be regarded as a co-sponsor and would then require insurance or indemnity cover.
Letters of Access
Letters of access enable NHS employees or staff with an honorary clinical contract (e.g. clinical academics) with one NHS organisation to conduct research in another NHS organisation.
Local Research Network
Leadership Support & Development Programme
Marketing Authorisation (MA)
A medicinal product may only be placed on the market in the European Economic Area (EEA) when a marketing authorisation has been issued by the competent authority of a Member State (or EEA country) for its own territory (national authorisation) or when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a Community authorisation).
Marketing Authorisation Holder (MAH)
The entity that has been granted a Marketing Authorisation. Marketing Authorisation Holders must be established within the EEA.
Mental Capacity Act
model Clinical Investigation Agreement
model Clinical Investigation Agreement: for medical devices, covers the running of the study, not design of prototype or design of protocol; standard template for the UK (use is not obligatory)
Medicines for Children Research Network
model Clinical Trial Agreement
model Clinical Trial Agreement: for IMP studies with commercial sponsor/CRO conducted; standard template for the UK (use is not obligatory)
Any instrument, apparatus, implement, machine, appliance, implant, software, material, or other similar or related article
a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices, and
b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Medicines and Healthcare Products Regulatory Agency (MHRA)
The MHRA is the competent authority for the UK in relation to the Directive 2001/20/EC and the Clinical Trials Regulations, and for Medical Devices, the competent authority in relation to the Medical Devices Regulations 2002.
Medicines reconciliation is the process some hospital staff will use to find out what medicines you were taking before you came into hospital and make sure you are prescribed the correct medications when you are admitted.
Definition submitted by a consensus panel held at Sheffield Teaching Hospitals Trust with members of an existing PPI panel. The piece of work has been featured in Health Expectations and also won best poster at the 2018 HSRPP: Health Services Research & Primary Practice Conference in Newcastle.
Members of the public (or public)
INVOLVE uses this term to cover:
• patients and potential patients
• people who use health and social care services
• informal (unpaid) carers
• disabled people
• members of the public who are potential recipients of health promotion programmes, public health programmes, and social service interventions
• groups asking for research because they believe they have been exposed to potentially harmful substances or products (for example pesticides or asbestos)
• organisations that represent people who use services.
Other organisations have different definitions of this term.
Mental Capacity Act (2005)
Provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions. It makes it clear who can take decisions, in which situations, and how they should go about this.
The research provisions of the Mental Capacity Act 2005 do not apply to the conduct of CTIMPs.
A mentor is a person willing to share their experience, knowledge and wisdom to help, guide and support someone who is less experienced. Mentors act as friends, teachers and advisers. A person who is newly involved in research can ask for a mentor to help them adjust to their new role.
Combining data from multiple independent studies. May be undertaken in evidence syntheses.
The term methodology describes how research is done – so it will cover how information is collected and analysed as well as why a particular method has been chosen.
Medicines for Human Use (Clinical Trials) Regulations: SI 2004:1031 and subsequent amendments 2006:1928, 2006:2984 ,2008:941, 2009:1164 and 2010:1882 are the UK Statutory Instruments translating EU directives 2001/20/EC and 2005/28/EC into UK law, laying down the legal requirements for conducting CTIMPs in the UK
Mental Health Research Network
In relation to a CTIMP, defined in ‘The Medicines for Human Use (Clinical Trials) Regulations’ as a person under the age of 16.
model Non-Commercial Agreement: for clinical research studies; standard template for the UK (use is not obligatory)
The person designated by the sponsor to perform site visits and conduct the monitoring process; eg check whether there are any deviations from the protocol and that all source data was transferred into the Case Report Forms correctly
Monitor (also known as a Clinical Research Associate (CRA))
An individual who undertakes monitoring activities for a trial.
Maintaining contact with funded projects to ensure they progress satisfactorily and deliver meaningful results.
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
Monitoring research involves keeping up to date with the progress of a research project. This will include ensuring that the researchers are carrying out their research according to their research proposal or protocol, that the research is keeping to time and budget and that the research is being conducted ethically.
Illness or harm.
Medical Research Council, the main UK Government source of funds for biomedical and early stage clinical research. The MRC funds the researcher-led workstream of the EME Programme.
MRC-NIHR National Phenome Centre
Methodology Research Programme
A study conducted according to a single protocol but carried out at more than one site and by more than one investigator; one CI oversees several local PIs
A trial/study conducted at more than one site.
A trial conducted at several geographical sites. Trials are sometimes conducted among several collaborating institutions, rather than at a single institution – particularly when large numbers of participants are needed.
National Information Governance Board for Health and Social Care (NIGB)
An independent statutory body that was responsible for Section 251 of the NHS Act 2006 in England and Wales; and reviewed applications for use of identifiable data where consent was not practicable. From April 2013 this function will transfer to the Health Research Authority (HRA) who will convene a Confidentiality Advisory Group (CAG) to perform this function.
National Research Ethics Service (NRES)
The National Research Ethics Service (NRES) is the core function of the Health Research Authority (HRA) and provides help and leadership for NHS Research Ethics Committees (RECs) by co-ordinating the development of operational and infrastructure arrangements in support of their work.
National Screening Committee
The UK national body that advises on screening programmes within the NHS. The National Screening Committee is an important policy customer of the NETS programmes.
National Cancer Research Network
We are needs-led because we assess the important questions and the priority they should be answered in. We actively ensure that our programmes meet the needs of decision makers. We ensure that we are needs-led throughout the funding pipeline, by actively assessing need and priority for all funding streams.
NIHR Evaluation, Trials and Studies Coordinating Centre
NIHR Evaluation, Trials and Studies programmes; a suite of NIHR programmes funding clinical trials and other studies relevant to the NHS and public health.
National Health Service
NHS Economic Evaluation Database
NHS Permission for research (formerly known as R&D Approval) confirms that appropriate checks have been made and that clinical negligence will be covered by NHS indemnity schemes or by independent contractors’ professional indemnity insurance during the course of the research. In addition, where the staff of an NHS organisation were responsible for designing the study, NHS permission confirms that indemnity is provided for harm arising from the design of the study.
NHS permission for research ensures that:
a) The organisation is aware of the potential impact of the research in terms of risks and resources.
b) The organisation has made the necessary arrangements to support the activity.
c) All the activities for which the organisation is responsible are compliant with the law.
d) The organisation accepts vicarious liability for the activities of staff for which it is responsible.
NHS Permission Letter
Letter confirming that NHS Permission has been given and the study can commence. Similar terms are used for the permission letter issued in other UK countries.
NHS R&D Office
The responsible person / team acting on behalf of the organisation in matters relating to R&D management. The NHS R&D Office may delegate some of its functions to other parties.
NB. Where a trial is run without NHS involvement, the term NHS R&D office may often be replaced with the term ‘sponsor’s office’.
NHS research is research carried out in the NHS or funded by the NHS. This includes research that takes place in local hospitals or GP surgeries, and larger studies commissioned by the NHS at a national level, for example:
• a study based in a GP surgery looking at people’s experience of long-term chronic pain
• a randomised controlled trial to look at the best treatment for people with bowel cancer.
The National Institute for Health and Clinical Excellence recommends which treatments should be provided by the NHS. NICE makes extensive use of evidence generated by the NETS programmes.
National Information Governance Board for Health and Social Care Ethics and Confidentiality Committee (NIGB HSC ECC): formerly PIAG, gives approval for projects using patient data without obtaining consent
The National Institute for Health Research was established in 2006 to provide the framework through which the Department of Health can position, maintain and manage the research, research staff and research infrastructure of the NHS in England as a national research facility.
NIHR CRN CC
National Institute for Health Research Clinical Research Network Coordinating Centre
National Institute of Health Research Information Systems
NIMP (or non-IMP)
Non-Investigational Medicinal Product: product used alongside IMP but not directly under investigation in the research study, e.g. a challenge agent
NIHR Office for Clinical Research Infrastructure
Non Interventional Trial
A study of one or more medicinal products which have a marketing authorisation, where the following conditions are met:
a) The products are prescribed in the usual manner in accordance with the terms of that authorisation
b) The assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol
but falls within current practice
c) The decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study
d) No diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily
applied in the course of the particular therapeutic strategy in question, and
e) Epidemiological methods are to be used for the analysis of the data arising from the study.
Non Investigational Medicinal Product (NIMP)
A Non Investigational Medicinal Product (NIMP) is a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial. Examples include concomitant or rescue/escape medication used for preventive, diagnostic or therapeutic reasons and/or medication given to ensure that adequate medical care is provided for the subject during a trial. See EU Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Products (NIMPs) (PDF, 47 KB).
Trials that do not involve an Investigational Medicinal Product (IMP) as defined by the MHRA, and therefore do not fall within the scope of the Medicines for Human Use (Clinical Trials) Regulations 2004.
A trial designed to determine whether the effect of a new treatment is not worse than a standard treatment by more than a pre-specified amount.
Changes to the details of a study that have no significant implications for the subjects, the conduct, the management or the scientific value of the study (sometimes referred to as administrative amendments). Examples may be as follows:
- Correction of typographical errors in the protocol or other study documentation
- Amended contact details for the sponsor or project staff
- Changes in funding arrangements
- Appointment of new support staff
- Changes in the documentation used to record study data
- Changes in the logistical arrangements for transporting or storing samples
National Research Ethics Service
A study in which the investigators do not seek to intervene, but simply observe the course of events. There is a greater risk of selection bias than in experimental studies.
Other Government Departments
Describes a clinical trial in which masking is not used. That means that all parties involved with the trial know which participants have been assigned which interventions.
The Office for Strategic Coordination of Health Research (UK wide)
A component of a participant’s clinical and functional status after an intervention has been applied, that is used to assess the effectiveness of an intervention.
Outcome measures are measurements of the effects of a treatment or service. They might include physical measurements – for example measuring blood pressure, or psychological measurements – for example measuring people’s sense of well-being. So if someone takes part in research, they may be asked questions, or they may be asked to have extra tests to assess how well the treatment or service has worked.
Published results from a research project. NETS projects often generate papers that are published in the scientific literature. Full details of NETS projects and their results are published in special reports or journals. Some projects generate briefing papers or other outputs for particular audiences.
A participant is someone who takes part in a research project. Sometimes research participants are referred to as research ‘subjects’.
Participant Identification Centres (PICs)
Organisations which refer potential participants to a research team at another organisation, but do not conduct trial related activity themselves. If activities such as consent take place, then the site would not be classed as a PIC.
Participant Information Sheet (PIS)
A document explaining all relevant study information to assist the potential subject in understanding the expectations and requirements of participation in a clinical trial.
Taking part in a research study, for example people being recruited to take part in a clinical trial or another kind of research study, joining in a focus group or completing a questionnaire.
This is a type of research where researchers and people who use services or carers are partners in a research project. The research addresses an issue of importance to service users or carers, who are involved in the design and conduct of the research, and the way the findings are made available. The aim of the research is to improve people’s lives. This isn’t a research method – it’s an approach to research, a philosophy.
Patient and Public Involvement
An active partnership between patients and the public and researchers in the research process, rather than the use of people as ‘subjects’ of research.
Patient and public involvement in research is often defined as doing research ‘with’ or ‘by’ people who use services rather than ‘to’, ‘about’ or ‘for’ them. This would include, for example, involvement in the choice of research topics, assisting in the design, advising on the research project or in carrying out the research.
Patient information leaflet / patient information sheet
Researchers must provide a patient information leaflet to everyone they invite to take part in a research study, to ensure people can make an informed decision about this. The leaflet explains what taking part will involve and should include details about:
• why the research is being done, how long it will last, and what methods will be used
• the possible risks and benefits
• what taking part will practically involve, for example extra visits to a hospital or a researcher coming to interview someone at home
• what interventions are being tested, or what topics an interview will cover
• how the researchers will keep participants’ information confidential
• what compensation is available to people if they are harmed as a result of taking part in the research
• who to contact for further information
• how the results will be shared with others.
Patient/Participant Consent Form
Primary Care Research Network
Primary Care Trust
Product Development Awards
Programme Development Grants
Peer interviewing is where people are interviewed by others who have a similar experience to them – their peers. For example, in a project to find out about children’s experiences of after school care, children with experience of using after school care may act as peer interviewers, asking other children about their experience. Some researchers believe that this kind of interviewing enables people to talk more freely about their experience.
A reviewing process for checking the quality and importance of reports of research. An article submitted for publication in a peer-reviewed journal is reviewed by other experts in the area.
Peer review / refereeing
Peer reviewing is where a research proposal or a report of research is read and commented on by people with similar interests and expertise to those who wrote the proposal or report. Peer reviewers might be members of the public, researchers, or other professionals. Peer review helps to check the quality of a report or research proposal.
Members of the public who act as peer reviewers may choose to comment on:
• whether the research addresses an important and relevant question
• the methods used by researchers
• the quality of public involvement in the research.
Perspectives / user perspectives
A user perspective is often what people with experience of using health or social services are asked to bring when they get involved in research. They are asked to provide ideas, comments and suggestions based on the unique insight they have from their knowledge and experience of life with a health condition. They cannot be representative of everyone who uses a particular service, but they can offer their own perspective, and often that of other people.
Programme Grants for Applied Research Programme
The science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines.
Phase of a Trial
The phases of a clinical trial can generally be categorised in the following terms:
- Phase I – Human pharmacology
- Phase II – Therapeutic exploratory
- Phase III – Therapeutic confirmatory
- Phase IV – Therapeutic use.
Further description of each can be found in Table 1 of the ICH E8: General Considerations for Clinical Trials (PDF, 225 KB).
Public Health Research, one of the NETS programmes. The PHR Programme evaluates interventions taking place outside of the NHS that aim to improve public health.
Public Health Research Programme
Principal Investigator: The lead person at a single site designated as taking responsibility within the research team for the conduct of the study
Patient Information Advisory Group (now NIGB)
Participant Identification Centre: NHS or other organisation which only identifies participants from a database etc, but recruitment/receiving consent and study conduct are managed elsewhere
We expect that when pilot or feasibility studies are proposed by applicants, or specified in commissioning briefs, a clear route of progression criteria to the substantive study will be described. Listing clear progression criteria will apply whether the brief or proposal describes just the preliminary study or both together. Whether preliminary and main studies are funded together or separately may be decided on practical grounds.
Pilot studies are a smaller version of the main study used to test whether the components of the main study can all work together. It is focused on the processes of the main study, for example to ensure that recruitment, randomisation, treatment, and follow-up assessments all run smoothly. It resembles the main study in many respects, including an assessment of the primary outcome. In some cases, this will be the first phase of the substantive study and data from the pilot phase may contribute to the final analysis; this can be referred to as an internal pilot. Or, at the end of the pilot study, the data may be analysed and set aside, a so-called external pilot.
Participant or Patient Information Sheet: An information leaflet given to those who have been invited to participate in a research study. The sheet is designed to provide the potential participant with sufficient information to allow that person to make an informed decision on whether or not they want to take part
A placebo is a fake or dummy treatment that is designed to be harmless and to have no effect. It allows researchers to test for the ‘placebo effect’. The placebo effect is a psychological response where people feel better because they have received a treatment, and not because the treatment has a specific effect on their condition. By comparing people’s responses to the placebo and to the treatment being tested, researchers can tell whether the treatment is having any real benefit.
A programme (e.g. a talk or a piece of music) made available in digital format for automatic download over the internet.
Post Hoc Analysis
From Latin ‘after this’, post hoc analysis consists of looking at the data after the experiment has concluded for patterns that were not specified up front. It is sometimes called by critics, data dredging.
The probability of rejecting the null hypothesis when a specific alternative hypothesis is true. In clinical trials, power is the probability that a trial will detect, as statistically significant, an intervention effect of a specified size. Ideally, we want a test to have high power.
Patient and Public Involvement
A trial that aims to test a treatment policy in a ‘real life’ situation, when many people may not receive all of the treatment, and may use other treatments as well.
Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.
The outcome of greatest importance.
Experimental studies generating new data (cf. secondary research, which analyses existing data).
Principal Investigator (PI)
For CTIMPs, the authorised health professional responsible for the conduct of that 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.
For research other than CTIMPs: The person responsible, individually or a leader of the researchers at a site, for the conduct of a study at that site.
Rigorously examining potential topics for research to identify their importance and where the need for new evidence is greatest.
The chance or risk of something happening.
Database of Prospectively Registered Systematic Reviews
Protocol / research protocol
A protocol is the plan for a piece of research. It usually research protocol includes information about:
• what question the research is asking and its importance/relevance
• the background and context of the research, including what other research has been done before
• how many people will be involved
• who can take part
• the research method
• what will happen to the results and how they will be publicised.
A protocol describes in great detail what the researchers will do during the research. Usually, it cannot be changed without going back to a research ethics committee for approval.
Policy Research Programme (DH)
Patient Safety Translational Research Centre
Public health research
Public health is concerned with promoting good health, preventing disease and protecting people from hazards, rather than treating illnesses. It covers topics like the control of infectious diseases, vaccinations, and helping people to adopt healthy lifestyles.
Public health research involves finding out new knowledge (or testing out existing ideas) to do with public health – so it might address questions about:
• the best ways to help people stop smoking
• how Bird Flu spreads.
INVOLVE defines public involvement in research as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. This includes, for example, working with research funders to prioritise research, offering advice as members of a project steering group, commenting on and developing research materials, and undertaking interviews with research participants. When using the term ‘public’ we include patients, potential patients, carers and people who use health and social care services as well as people from organisations that represent people who use services.
Quality of Life Questionnaire
A machine-readable label that consists of square dots arranged in a square grid on a white background. The label can be read by the camera on a telephone and when a photograph is taken it will take you to an internet site with more information.
Qualified Person (QP)
All manufacturing activities will need to be conducted in a unit which has an IMP manufacturing authorisation with a named Qualified Person (QP).
This person ensures that an investigation medicinal product (IMP) batch is only released if there is documentation to confirm compliance with Good manufacturing Practice (or equivalent).
Detailed subjective evaluation, used to capture views of individuals’ and groups.
Qualitative research is used to explore and understand people’s beliefs, experiences, attitudes or behaviours. It asks questions about how and why. Qualitative research might ask questions about why people want to stop smoking. It won’t ask how many people have tried to stop smoking. It does not collect data in the form of numbers.
Qualitative researchers use methods like focus groups and interviews (telephone and face-to-face interviews).
Quality Assurance (QA)
All those planned and systematic actions that are established to ensure that the trial is performed and the data is generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
Numerical evaluation of an intervention.
In quantitative research, researchers collect data in the form of numbers. So they measure things or count things. Quantitative research might ask a question like how many people visit their GP each year, or what proportion of children have had an MMR vaccine, or whether a new drug lowers blood pressure more than the drugs that are usually used.
Quantitative researchers use methods like surveys and clinical trials.
A questionnaire is a prepared set of written questions used to obtain information from research participants. Questionnaires can be completed on paper, using a computer or with an interviewer.
Research and Development
Research and Development: often name of Department within NHS hospitals giving permission to conduct projects on those facilities with patients/staff
Regulation & Governance
Research Assessment Exercise
There are two components to randomisation: the generation of a random sequence, and its implementation, ideally in a way so that those entering participants into a study are not aware of the sequence (concealment of allocation).
Randomised controlled trial
A controlled trial compares two groups of people: an experimental group who receive the new treatment and a control group, who receive the usual treatment or a placebo. The control group allows the researchers to see whether the treatment they are testing is any more or less effective than the usual or standard treatment.
In a randomised controlled trial, the decision about which group a person joins is random (that is based on chance). A computer will decide rather than the researcher or the participant. Randomisation ensures that the two groups are as similar as possible, except for the treatment they receive. This is important because it means that the researcher can be sure that any differences between the groups are only due to the treatment.
Research Capability Funding
Research Design Services
Re-tweeting is passing on someone else’s tweet. It means a lot more people will see the tweet.
Research Ethics Committee: authorised by NRES to review study documents for research taking place in the NHS, or social services. Some REC specialise in Clinical Trials, or topics such as research in children, MCA. See NRES website for more detail and other types of research http://www.nres.npsa.nhs.uk/ All Research in NHS/social services must have been reviewed by a UK REC
The area of authority or responsibility of an individual, group, or organisation.
A bias caused by only a subset of all the relevant data being available. The publication of research can depend on the nature and direction of the study results. Studies in which an intervention is not found to be effective are sometimes not published. Because of this, systematic reviews that fail to include unpublished studies may overestimate the true effect of an intervention. In addition, a published report might present a biased set of results.
As a representative, you are expected to speak on behalf of a larger group of people. If you’ve been asked to get involved in research as a representative of a particular group, you may want to think about how you can be confident that you are representing a wider range of people’s views, rather than just offering your own perspective.
The term research means different things to different people, but is essentially about finding out new knowledge that could lead to changes to treatments, policies or care.
The definition used by the Department of Health is: “The attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.”
Research commissioners write a research brief. The brief describes why they want to commission a piece of research, what questions the research should address and sometimes how the research should be carried out. It might include information about when the research needs to be completed and how much money is available. Researchers then write a research proposal that explains how they will address the research brief.
Research governance is a process aimed at ensuring that research is high quality, safe and ethical. The Department of Health has a Research Governance Framework for Health and Social Care, which everyone involved in research within the NHS or social services must follow.
Research grants are given to enable researchers to carry out a particular piece of research. They might amount to millions of pounds for a major study about genetics for example, or a few hundred pounds for a local study about people’s experience of using a particular service. Usually, in order to get research grants, researchers have to write a research proposal and receive a positive peer review.
Research networks aim to bring together people who have an interest in research about a particular condition or group of people. Networks might be national or local.
The Department of Health supports research networks to promote research in specific areas. These include:
• medicines for children
• mental health
These networks encourage researchers to work together and improve the quality of research.
Outside the NHS there are other types of research networks. For example, the Alzheimer’s Society and the Multiple Sclerosis Society support research networks of service users and carers who are actively involved in research.
The term research partner is used to describe people who get actively involved in research, to the extent that they are seen by their ‘professional’ colleagues as a partner, rather than someone who might be consulted occasionally.
Partnership suggests that researchers and service users/carers have a relationship that involves mutual respect and equality.
A system for HEI employed researchers/postgraduate students who need to undertake their research within NHS organisations, which provides evidence of the pre-engagement checks undertaken on that person in line with NHS Employment Check Standards (among them CRB and occupational health checks)
This is usually an application form or set of papers that researchers have to complete to say what research they want to do and how they want to do it. It will also cover the aim of the research, what the research questions are, who will be involved (both as participants and in carrying out the research), the time-scale and the cost.
Researchers are the people who do the research. They may do research for a living, and be based in a university, hospital or other institution, and/or they may be a service user or carer.
Open calls for researchers to apply for funding for their own topics and questions. These applications are prioritised in terms of NHS or other information need in a process similar to that of the commissioned workstreams. Applications are assessed for scientific quality, feasibility and value for money.
Those conducting a trial (or study).
A study in which the outcomes have occurred before the study commenced. Case-control studies and cohort studies can be retrospective, but randomised controlled trials never are.
An individual with specific knowledge, experience and skills in a field of practice who undertakes an independent review of a grant application, commissioning brief or document for publication. The comments made by this independent ‘external reviewer’ are used to inform the funding decision or the preparation of a written document.
Research for Patient Benefit: NIHR research funding stream
See MRC/DH/MHRA Joint Project: The Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products (PDF, 247 KB) and the MHRA website for further information.
Research Liaison Officer
Research Management and Governance
Research Methods Programme
Research Support Services
The number of participants in the trial. The intended sample size is the number of participants planned to be included in the trial, usually determined using a statistical power calculation. The sample size should be adequate to provide a high probability of detecting as significant an effect size of a given magnitude if such an effect actually exists.
The achieved sample size is the number of participants enrolled, treated or analysed in the study.
We are science-added because we ask if the proposal meets the scientific quality we insist on, and how we can support the delivery and improvement of quality. We actively apply scientific knowledge, expertise and methods to support the scientific quality of proposals and funded research. We communicate closely with the research community, and provide significant post award support and monitoring.
Source Data Verification: checking the original data record, such as lab reports, patient medical notes against what was transferred onto the CRF/into a database
An outcome used to evaluate additional effects of an intervention deemed as being less important than the primary outcomes.
A review of individual studies (each of which is called a primary study). A systematic review is a secondary study.
Secret Facebook group
Nobody on Facebook can see a secret group other than those in the group. This group will not appear anywhere on a person’s profile, and only those within the group can see who the members are and what is posted. For more information see http://facebook.about.com/od/PagesGroups/ss/Everything-You-Need-To-KnowAbout-Facebook-Groups.htm
A list of corrections to the case report form that can be made by the sponsor’s data management staff without the requirement for case-by-case referral to the investigator. For example, if a case report form page lists concomitant medications taken by a patient but the box stating ‘Are there any medications this cycle?’ is blank, the box may be ticked by the data manager.
A list of such data correction conventions should be agreed by the investigator prior to data management activities taking place.
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
Any adverse event or adverse reaction that results in death, is life-threatening*, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
Comment: Medical judgement should be exercised in deciding whether an adverse event/reaction should be classified as serious in other situations. Important adverse events/reactions that are not immediately life-threatening or do not result in death or hospitalisation, but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definition above, should also be considered serious.
* Life-threatening in the definition of a serious adverse event or serious adverse reaction refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe.
Serious Breach of GCP or Protocol
A “serious breach” is a breach which is likely to effect to a significant degree:
a) the safety or physical or mental integrity of the subjects of the trial; or
b) the scientific value of the trial.
Adverse drug reaction which falls in to one of the serious criteria and therefore warrants expedited reporting (serious = resulting in hospitalisation, prolonged hospitalisation, death, life-threatening, congenital anomaly/birth defect or persistent or significant disability/incapacity)
Service Level Agreement (SLA)
A communication document that makes clear what the supplier will deliver and what the organisation will ensure. It is based on the conditions of contract and specification and does not in any way replace them.
Service user or user
A service user is someone who uses or has used health and/or social care services because of illness or disability. Some people do not like this term because they feel it has negative connotations.
The research setting is the environment in which research is carried out. This could be a laboratory or a ‘real’ setting, such as the subject’s working environment if you are conducting research into people’s working lives.
Adverse drug reaction which falls in to one of the serious criteria and therefore warrants expedited reporting (serious = resulting in hospitalisation, prolonged hospitalisation, death, life-threatening, congenital anomaly/birth defect or persistent or significant disability/incapacity)
Statutory Instruments: document which defines UK law in on a specific topic, e.g. how to manage a clinical trial
Single Technology Appraisal (STA)
A review of evidence on one specific treatment, usually carried out for policy customers such as NICE.
The NHS organisation in which study activities and assessment are performed or the location(s) where trial-related activities are actually conducted. Each site/Trust needs to give R&D approval
A messaging service which enables users to communicate with people by voice, video and instant messaging over the internet.
Service Level Agreement
Site Management Organisation
Summary of Product Characteristics: smaller version of Investigator Brochure with details on pharmacological effects, side effects, but issued for a product that already holds a marketing licence
Social care research
Social care refers to a range of services provided across different settings, usually in the community. These include:
• home care, day care and residential care for older people
• residential care and fostering for children
• support for parents of disabled children
• supporting mental health service users, physically disabled people and people with learning difficulties
• support for carers
Social care research involves finding out new knowledge (or testing out existing ideas) to do with social care – so social care research might address questions about:
• people’s experience of using different home care services
• the best ways to train new foster parents.
Interaction among people within virtual communities and networks, for example blogs, Facebook and Twitter.
Social networking service
A platform to build social networks among people who share interests, activities or connections. Twitter and Facebook are examples of social networking services.
Standard Operating Procedure: detailed written instructions designed to achieve uniformity of the performance of a specific function
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. Source data are contained in source documents (original records or certified copies). Source data may be in hard copy or electronic format.
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
School for Primary Care Research
In screening/diagnostic tests this is a measure of a test’s ability to correctly identify people who do not have the disease.
School for Public Health Research
The individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming that there are proper arrangements in place to initiate, manage and monitor, and finance a study. Responsibilities are defined by the Research Governance Frameworks and by the Clinical Trials Regulations.
For CTIMPs, the sponsor (or their legal representative) must be named on the Clinical Trial Authorisation. The sponsor may delegate functions as necessary to comply with the Clinical Trials Regulations, for example to the Chief Investigator or Clinical Trials Unit.
The sponsor is responsible for posting clinical trial summary results in EudraCT within six or twelve months following the end of the trial, depending on the type of trial.
Stroke Research Network
Systematic Reviews Programme
Site Specific Assessment: An assessment performed to establish the suitability of a Principal Investigator and a site for the conduct of research; SSA will be performed by the Participating CLRN for each research site (NHS organisation), using an SSI form available in IRAS
School for Social Care Research
Site Specific Information: local detail to inform SSA including qualifications/expertise of the PI and wider research team, study procedures, departmental capacity to absorb project (includes Pharmacy, Pathology, Radiology) and departmental leads signatures; The SSI form is completed in IRAS
Standard Operating Procedure (SOPs)
Written instructions to achieve uniformity of the performance of a specific function.
Statistical Analysis Plan
A statistical analysis plan is a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.
A result that is unlikely to have happened by chance.
Statistics and statistical analysis
Statistics are a set of numbers (quantitative data) obtained through research. For example, the average age of a group of people, or the number of people using a service.
Statistical analysis uses a set of mathematical rules to analyse quantitative data. It can help researchers decide what data means. For example, statistical analysis can assess whether any difference seen between two groups of people (for example between the groups of people in a clinical trial) is likely to be a reliable finding or simply due to chance.
A social networking service that lets the user create stories or timelines using social media such as Twitter and Facebook.
An analysis in which the intervention effect is evaluated in a defined subset of the participants in a trial, or in complementary subsets, such as sex or age.
An individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control. The preferred term for the HRA, NRES and many key trials stakeholders is ‘Participant’ but the term ‘Subject’ is referenced in law for CTIMPs. See also Participant.
A change to the terms of the approval given by either:
- the competent authority (MHRA in the UK) or the research ethics committee or;
- a change to the protocol or any other document submitted with the applications,
which significantly affects one of the following:
- the safety or physical or mental integrity of study participants
- the conduct or management of the study
- the scientific value of the study
- the quality or safety of any investigational medicinal product used in the study.
A substantial amendment can be defined as an amendment to the protocol or any other study specific documentation, the terms of the REC application or the terms of the CTA application (as applicable) that is likely to affect to a significant degree the:
- The safety or physical or mental integrity of the subjects of the trial;
- The scientific value of the trial; The conduct or management of the trial; or
- The quality or safety of any investigational medicinal product used in the trial.
Other changes to the particulars of a study that qualify as substantial amendments include:
- A change of sponsor(s)
- Appointment of a new Chief Investigator and
- Extension of the research beyond the planned closing date for recruitment
A substantial amendment may not be made to a research study without the favourable opinion from the REC that gave a favourable opinion for the study (the main REC) and as applicable the MHRA. The only exceptions to this rule are:
- The Inclusion of a new research site or
- The Appointment of a new PI at an individual site
Both of these qualify as substantial amendments but as they require further SSA and approval from the REC there is no requirement for notice of amendment to the REC. These changes do still however need to be notified to the MHRA (as applicable)
Summary of Product Characteristics (SmPC or SPC)
The basis of information for health professionals on how to use the medicinal product safely and effectively. They are written and updated by pharmaceutical companies and are based on their research and product knowledge. It is then checked and approved by the UK or European medicines licensing agency.
The leaflet that is included in the pack with a medicine is a patient-friendly version of this document.
Survivor is a term some people who have used health or social care services use to describe themselves – they see this as a more empowering term than ‘patient’ or ‘sufferer’. For example, some people who have used mental health services or who have experienced mental or emotional distress call themselves survivors of the psychiatric system. Some people who have recovered from cancer call themselves cancer survivors.
If someone describes themselves as a survivor researcher, they are making a statement about the fact that they have used health or social care services as well as being a researcher.
Suspected Unexpected Serious Adverse Reactions (SUSAR)
An adverse reaction that is both unexpected (not consistent with the applicable product information) and also meets the definition of a Serious Adverse Event/Reaction.
View a flowchart (pdf, 180.98 KB) outlining the assessments required to determine whether a SUSAR has occurred.
Systematic reviews aim to bring together the results of all studies addressing a particular research question that have been carried out around the world. They provide a comprehensive and unbiased summary of the research.
For example, one clinical trial may not give a clear answer about the effectiveness of a treatment. This might be because the difference between the treatments being tested was very small, or because only a small number of people took part in the trial. So systematic reviews are used to bring the results of a number of similar trials together, to piece together and assess the quality of all of the evidence. Combining the results from a number of trials may give a clearer picture.
Systematic Reviews Programme
The SR Programme comprises four different entities whose core business is creating evidence synthesis, systematic reviews,training or supporting the creation of research. These are the: UK Cochrane Review Groups, UK Cochrane Centre, Centre for Reviews and Dissemination, and Technology Assessment Review Teams.
Technology Assessment Reviews
Trainees Coordinating Centre
Topic specific Clinical Research Network: includes DRN, DeNDRoN, NCRN, MCRN, MHRN and SRN
Technology Assessment Review (TAR)
A systematic assessment of an intervention (or group of interventions), usually undertaken for policy customers such as NICE.
A call for proposals in a particular area of medicine or health (e.g. obesity, dementia).
Activities carried out to identify suitable topics for research. These activities provide a way for individuals and groups to propose areas where good evidence is lacking or unanswered questions exist.
The degree to which a medicine is poisonous. How much of a medicine can be taken before it has a toxic effect.
The process of intervening with the aim of enhancing health or life expectancy. Sometimes, and particularly in statistical texts, the word is used to cover all comparison groups, including placebo and no treatment arms of a controlled trial and even interventions designed to prevent bad outcomes in healthy people, rather than cure ill people.
Transitional Research Fellowships
Trial Management Group (TMG)
The Trial Management Group normally includes those individuals responsible for the day-to-day management of the trial, such as the Chief Investigator, statistician, trial manager, research nurse, data manager. The role of the group is to monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to and take appropriate action to safeguard participants and the quality of the trial itself.
Trial Master File (TMF)
The Trial Master File contains all essential documents held by the sponsor/Chief Investigator which individually and collectively permits the evaluation of the conduct of a trial and the quality of the data produced.
A hospital, health centre, surgery or other establishment or facility in the UK at or from which a CTIMP, or any part of a CTIMP, is conducted.
Trial Steering Committee (TSC)
The role of the Trial Steering Committee (TSC) is to provide the overall supervision of the trial. Ideally, the TSC should include members who are independent of the investigators, their employing organisations, funders and sponsors. The TSC should monitor trial progress and conduct and advise on scientific credibility. The TSC will consider and act, as appropriate, upon the recommendations of the Data Monitoring Committee (DMC) or equivalent and ultimately carries the responsibility for deciding whether a trial needs to be stopped on grounds of safety or efficacy.
See MRC Guidelines for GCP for Clinical Trials 1998 for terms of reference and further guidance (Appendix 3).
Used to refer to a person conducting or publishing a controlled trial.
Translational Research Partnerships
Messages sent out on Twitter are called tweets. Your tweets are seen by others who follow you, and you see the tweets of people you follow. Your tweets can also be seen by anyone who looks at your profile.
A social networking service that allows users to exchange public messages of 140 characters or less, known as tweets.
Type A Trial
Trials involving medicinal products licensed in any EU Member State if:
- they relate to the licensed range of indications, dosage and form; or
- they involve off-label use (such as in paediatrics and in oncology etc.) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.
UK Cochrane Centre
UK Cochrane Review Groups
United Kingdom Clinical Research Collaboration
UK Clinical Research Network
UK Clinical Trials Gateway
UK Trade and Investment
Unexpected Adverse Reaction (UAR)
For CTIMPs: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s brochure for an unauthorised investigational product or summary of product characteristics (SmPC) for an authorised product).
Urgent Safety Measure (USM)
An appropriate measure required to be taken in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety.
Please refer to the Urgent Safety Measures station for more information.
User controlled research / user led research
User controlled research is research that is actively controlled, directed and managed by service users and their service user organisations. Service users decide on the issues and questions to be looked at, as well as the way the research is designed, planned and written up. The service users will run the research advisory or steering group and may also decide to carry out the research.
Some service users make no distinction between the term user controlled and user led research, others feel that user led research has a different, vaguer meaning.
They see user led research as research which is meant to be led and shaped by service users but is not necessarily controlled by them. Control in user led research in this case will rest with some other group of non-service users who also have an interest in the research, such as the commissioners of the research, the researchers or people who provide services.
A user researcher is someone who uses or has used health and/or social care services because of illness or disability, who is also a researcher. Not all researchers who use health or social care services call themselves user researchers. Calling yourself a user researcher is making a statement about your identity as a service user as well as a researcher.
Valid Research Application
A complete NIHR research application that has been received by the NHS provider following its submission via IRAS that enables regulatory reviews by other agencies (including but not limited to Research Ethics Committee and MHRA approval) to be conducted in parallel with the work on NHS permission by the contractor.
World Medical Association