Glossary

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• Accessible record

  In the context of the Data Protection Act 1998, an 'accessible record' means:

  a) a health record which is any record that:

  i. consists of information relating to the physical or mental health or condition of an individual, and

  ii. has been made by, or on behalf of, a health professional in connection with the care of that individual

  b) an educational record

  c) an accessible public record

   

• Adverse event / incident

  An adverse event or incident is any undesirable occurrence on a particular study.

  In relation to a study participant, it can be described as any unfavourable and unintended sign, symptom or disease temporally associated with participation in the research project.

  The term has also been used to describe unfortunate events that may have serious consequences for the research project, e.g. freezer failure resulting in the loss of tissue samples.

   

• Amendment

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

  Substantial amendments

  These require the issue of a favourable opinion from the main REC and NHS R&D departments. If the amendment has implications for the study in terms of the scientific peer review, the funding body should also be consulted. 

  Non-substantial amendments

  The REC, NHS R&D departments (if appropriate) and sponsor(s) may require notification of non-substantial amendments. Please note that NHS RECs do not require notification of non-substantial amendments.

  Please see Protocol amendments for more information.

   

• Anonymised data / information

  Anonymised data are data prepared from personal information, but from which the person cannot be identified by the recipient of the information. The term is used within the Data and Tissues Tool Kit when referring to robustly pseudonymised / linked anonymised data or unlinked anonymised data.

  Pseudonymised data, also referred to as linked anonymised

  This is anonymous to the people who receive and hold it (e.g. a research team), but contains information or codes that would allow others (e.g. those responsible for the individual's care) to identify an individual from it.

  Unlinked anonymised data, or truly anonymised data

  This contains no information that could reasonably be used, by anyone, to identify the individual or research participant.

   

• Anonymised tissue

  The Human Tissue Authority consider that tissue is anonymised if the researcher is not in possession, and is not likely to come into possession, of information from which the individual can be identified. This does not mean that samples must be permanently unlinked, and coding samples meets these requirements.

   

• Archiving

  The retention of valuable research data which may have secondary use, or may be analysed further to verify results or as part of a meta-study; and the retention of study files which demonstrate the compliance of the investigator and sponsor(s) with GCP and regulatory requirements.

  During archiving it should be ensured that data are properly selected, stored, can be accessed and that logical and physical integrity are maintained over time, including security and authenticity.

  Periods of retention will depend on the nature of the research and sponsor's and funder's requirements. Please see the Archiving Research Scenario for more guidance.

   

• Audit

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

  The Department of Health's minimum standards for research governance state that at least 10% of projects should be routinely audited. Audit should look at areas such as: protocol amendments, start and stop dates, changes to inclusion/exclusion criteria, changes to the consent procedure, changes to recruitment, funding, research team or the participant information sheet, approvals for amendments, adverse events, health and safety, intellectual property, subject logs, recruitment, consent, and changes to data management.

  A distinction should be made between monitoring and auditing. All research activity should be monitored by those conducting the research routinely. In addition, an organisation should conduct formal audit of a selection of research projects/activity.

   

• Authorisation

  The Human Tissue Act 2004 uses the term 'consent', whereas the Human Tissue (Scotland) Act 2006 uses the term 'authorisation'.

   

• Bodily material

  The Human Tissue Authority defines bodily material in the context of DNA analysis as: any tissue or sample that has come from a human body and contains human cells, this includes gametes, and hair and nails from the living and deceased. It excludes embryos outside the body, established cell lines and extracted cellular components where no whole cells remain (i.e. extracted DNA or RNA).

  Under the Human Tissue Act 2004, it is an offence to have bodily material with the intent of analysing its DNA without qualifying consent, subject to certain exceptions, which are outlined in the HTA's Code of Practice on Consent. This applies UK-wide.

   

• Caldicott Guardian

  The Department of Health defines a Caldicott Guardian as "a senior person responsible for protecting the confidentiality of patient and service-user information and enabling appropriate information-sharing. The Guardian plays a key role in ensuring that the NHS, Councils with Social Services responsibilities and partner organisations satisfy the highest practicable standards for handling patient identifiable information".
  
  

• Chief Investigator (CI)

  The Investigator with overall responsibility for the research, who is accountable to their employer, and through them to the sponsor. In a multi-site study the CI has responsibility for design, management and reporting of the study and coordinating investigators who take the lead at each site (i.e. the PIs or Principal Investigators).

  All applications for ethical review should be submitted by the CI.

   

• Child

  There are different and confusing definitions of 'child' that affect consent issues in medical research. The situation is best explained in the Children station.

   

• Clinical trial

  With the advent of the Clinical Trial Regulations, the term clinical trial is used to describe a trial that tests the safety or efficacy of an investigational medicinal product, i.e. a clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. To avoid confusion we recommend that the term Clinical Trial of an Investigational Medicinal Product or CTIMP be used for this definition.

  In the academic sector the term clinical trial is commonly used more loosely to describe:

  Any prospective evaluation of a health care intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle advice (e.g. dietary advice).
  
  

• 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, i.e. a trial that tests the safety or efficacy of an investigational medicinal product. For more information, please see the Clinical Trials Tool Kit, Is the trial within the scope of the UK Regulations? station.

   

• Clinical Trial Regulations

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

   

• Coded

  Coded samples or data contain identifiable personal information in which the details that could identify people are concealed in a code, but which can be readily decoded by those using it.

   

• Competence

  The ability of a person, given the necessary information, to understand the nature and the consequences of the proposed procedure or treatment, and to use that information to make a valid choice in accordance with their own fundamental values.

  In relation to research this would impact upon the person's ability to fully participate within the consent process - i.e. their ability to understand the research project and their proposed role within it and to then make a decision as to whether they would like to participate in the project or not, based on this information.

   

• Confidential information

  Any information obtained by a person on the understanding that they will not disclose it to others, or obtained in circumstances where it is expected that they will not disclose it. The law assumes that whenever people give personal information to health professionals caring for them, it is confidential as long as it remains personally identifiable. See also 'Personal data'.

   

• Confidentiality

  The duty of persons to whom personal information has been given, not to disclose it without consent or other strong justification (see Duty of Confidentiality/Confidence).

   

• Consent

  An agreement to participate in research, based upon the participant's understanding of the information which has been provided through the course of the consent process.

  Consent is only considered valid when it is:

      -  Voluntarily given;
      -  By a competent person;
      -  Once they have been appropriately informed; and
      -  In practice, indicated (e.g. verbally or signed consent form)

   

• Consent form

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

   

• Custodian

  The custodian is responsible for the safekeeping of data and/or tissue samples and control of their use, and eventual disposal (if required), all in accordance with legislation and the terms of the consent given by the donor.

  Custodianship implies some rights to decide how the data/samples are used and by whom, and also responsibility for safeguarding the interests of the donors.

   

• Data

  In the context of the Data Protection Act 1998 'data' means information which:

  a) is being processed by means of equipment operating automatically in response to instructions given for that purpose,

  b) is recorded with the intention that it should be processed by means of such equipment,

  c) is recorded as part of a relevant filing system or with the intention that it should form part of a relevant filing system,

  d) does not fall within paragraph (a), (b) or (c) but forms part of an 'accessible record',

  e) is recorded information held by a public authority and does not fall within any of paragraphs (a) to (d)

  Examples of data are a health record (e.g. medical notes); a database or spreadsheet; paper records; etc rather than information or knowledge that you know but which is not held in a written or electronic form.

  If you need further guidance on the concept of data, please refer to p1 of the Information Commissioner's Office What is personal data? – A quick reference guide.

   

• Data Controller

  The person who decides the purposes for which, and the manner in which, personal data is to be processed. This may be an individual or an organisation registered with the Information Commissioner's Office.

   

• Data curation

  The actions needed to maintain research data from point of creation to ensure they are fit for contemporary purpose and available for discovery and re-use. Implicit to this are the processes of 'archiving' and preservation. Higher levels of curation will involve maintaining links between datasets, annotation, published materials and other information resources.

   

• Data processing

  The processing of data includes obtaining, recording, holding or carrying out any operation on personal data.

   

• Data Processor

  Any person who processes data on behalf of the Data Controller (i.e. they are responsible for the obtaining, recording, holding and/or carrying out any other operation on personal data).

   

• Data Subject

  The person whose personal data is held by a Data Controller.

   

• Database

  A collection of research data that is organised and allows its contents to be easily accessed, managed and updated. The type of database used depends on the requirements of the study. A common type is the relational database, where data are related to each other in a systematic manner so that they can be reorganised and accessed in a number of different ways.

  A database may house one or many datasets.

   

• Dataset

  An organised collection of data that have a common theme, source or format; usually considered as a discrete entity.

   

• Designated Individual (DI)

  The individual designated on the Human Tissue Authority (HTA) licence to supervise the licensable activities carried out at their establishment. DIs are trained by the HTA to carry out this important role and they have statutory responsibilities they must fulfil.
  
  

• Disclosure

  Disclosure is the sharing of information with a third party.  Disclosure is often thought of as something to be avoided (e.g. leaving a memory stick or confidential papers in a public place or a third party hacking into a computer system).  However, there are certain circumstances when disclosure of identifiable information to a third party is entirely appropriate (e.g. when it is necessary to ensure the individual's health and well-being; where it is in the public interests; etc).  Disclosure of identifiable information with consent, or disclosure of anonymous information is common when conducting research and is appropriate.

   

• DNA analysis

  The Human Tissue Act 2004 uses the term DNA analysis. This is not defined in the Codes of Practice, it could be interpreted as the investigation of variation in the nuclear or mitochondrial DNA that forms the genome of an individual and may be inherited from parent to child.

  Under the Human Tissue Act 2004, it is an offence to have bodily material with the intent of analysing its DNA without qualifying consent, subject to certain exceptions, which are outlined in the HTA's Code of Practice on Consent. This applies UK-wide.

   

• Duty of Confidentiality/Confidence

  Anyone who receives information must respect its confidentiality (that is, not disclose it without consent or strong justification) if they receive it on the understanding that it is confidential, or in circumstances where there is an implicit expectation that they will not reveal it to anyone else.  A duty of confidence exists when:

      -  The information in question is not in the public domain

      -  There is a degree of sensitivity to the information

      -  It is provided with the expectation of being kept confidential

   

• Exclusion criteria

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

   

• Fair processing

  Fair processing means that an individual should normally have the opportunity to know which organisations hold information about them, and why (i.e. that it is fairly collected).  When people give information, they should be told what it will be used for and to whom it will be passed.  They should also be entitled to check records held about them and correct errors.  In research, fair collection is usually achieved through a formal consent process.

   

• Gene Therapy Advisory Committee (GTAC)

  The Gene Therapy Advisory Committee (GTAC) is the ethics committee for clinical trials of gene therapies. They define gene therapy as the deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes. To access your nearest GTAC committee please visit the Directory of NRES Research Ethics Committees on the NRES website. 

   

• Good Clinical Practice (GCP)

  Good Clinical Practice (GCP) is an ethical and scientific quality standard for designing, conducting and reporting trials that involve the participation of human subjects. The International Conference on Harmonisation (ICH) standardised practice across Europe, Japan and the USA.

  The relevant principles of GCP should be applied to any research that involves human participants, their tissues or data. The principles of GCP are listed in the MRC Guidelines for Good Clinical Practice in Clinical Trials, (see PDF page 11).

   

• Harm

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

   

• Hazard

  Anything that could cause harm.

   

• Health & Safety

  Health and Safety is a discipline, enshrined in primary legislation, concerned with preserving and protecting human and facility resources in the workplace. All employers are subject to the law and can be inspected.

   

• Healthy volunteers

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

   

• HTA Definition of Research

  A study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications or new knowledge.

   

• HTA licence

  The HTA license premises for storage of relevant material for research purposes in England, Wales and Northern Ireland. There are exemptions to the need for an HTA licence for research, best described in the HTA Licence station.

  The HTA also issues licences for human application under the EU Tissues and Cells Directive, in the whole of the UK.

   

• Human Fertilisation & Embryology Authority (HFEA)

  The Human Fertilisation & Embryology Authority (HFEA) is the UK's independent regulator overseeing safe and appropriate practice in fertility treatment and embryo research. The HFEA license and monitor centres carrying out IVF, donor insemination and human embryo research. They provide a range of detailed information for patients, professionals and Government.

   

• Human Tissue Authority (HTA)

  The Human Tissue Authority (HTA) regulates the removal, storage, use and disposal of human bodies, organs and tissue from the living and deceased.

  Under the Human Tissue Act 2004, the HTA has jurisdiction in England, Wales and Northern Ireland. For human application (under the EU Tissue and Cells Directive), the HTA has a UK-wide role.
  
  

• Human tissue/tissues or samples

  Generic term used to encompass human organs, tissues and biological samples. Depending on the context, human tissue or samples may be used in the Data and Tissues Tool Kit to describe 'relevant material', this is likely when used in reference to the Human Tissue Act 2004. Strictly speaking relevant material is a more specific term.

   

• Identifiable information

  See 'Personal Data'.

   

• Inclusion criteria

  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.

   

• Information Commissioner's Office (ICO)

  The Information Commissioner's Office is the UK's independent authority set up to promote access to official information and to protect personal information under the Data Protection Act 1998. Also the authority that deals with Freedom of Information in England, Wales and Northern Ireland.

   

• Information sheets

  See 'Participant/Patient information sheets'.

   

• Inspection

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

   

• Integrated Research Application System (IRAS)

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

   

• Linked anonymised data/information

  See 'Pseudonymised data/information'.

   

• Medical purposes

  In the context of the Data Protection Act 1998 'medical purposes' include preventive medicine, medical diagnosis, medical research, the provision of care and treatment and the management of healthcare services.

   

• Medicines and Healthcare products Regulatory Agency (MHRA)

  The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

  They have statutory powers both in the approval of drug / devices for licence and in approving Clinical Trials of Investigational Medicinal Products, and clinical investigations involving devices.

   

• Monitoring

  The process of monitoring a study should ensure that the rights and well-being of any participants are protected, the reported data are accurate and complete, and that the conduct of the study is in compliance with the approved protocol/amendments and with applicable regulatory/governance requirements.

  Monitoring should be built into the conduct of the study as a means to minimise risk, and should be ongoing and performed by members of the research team and people independent to it.
  
  

• NHS R&D Forum

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

   

• NHS Research Governance Framework

  The UK Health Departments' Research Governance Frameworks (RGF) document a set of standards and principles for carrying-out health related or social/community care research in the UK. It is mandatory for all research taking place in the NHS and using NHS resources. It aims to improve research and safeguard the public by:

      -  Enhancing ethical awareness and scientific quality
      -  Promoting good practice
      -  Reducing adverse incidents and ensuring lessons are learned
      -  Forestalling poor performance and misconduct

   

• NIGB (National Information Governance Board for Health and Social Care)

  National Information Governance Board for Health and Social Care (NIGB).  The Health and Social Care Act 2008 formally established the NIGB for England replacing PIAG as the statutory body with responsibility for Section 251 of the NHS Act 2006 (originally Section 60 of the Health and Social Care Act 2001).

   

• NIHR Clinical Research Network Coordinating Centre (NIHR CRN CC)

  The National Institute for Health Research Clinical Research Network Coordinating Centre (NIHR CRN CC) was established to support clinical research and to facilitate the conduct of trials and other well-designed studies within the NHS. As part of the UK Clinical Research Collaboration (UKCRC), it works towards the development of a world class infrastructure to support clinical research in the UK.
  
  

• NRES (National Research Ethics Service)

  The National Research Ethics Service (NRES) Head Office is a directorate within the National Patient Safety Agency and provides help and leadership for NHS Research Ethics Committee's (RECs) by co-ordinating the development of operational and infrastructure arrangements in support of their work. This includes implementing standards to ensure national consistency, providing training for REC members and Co-ordinators, identifying IT solutions for procedural management and establishing regional REC centres to manage RECs.

   

• Parent / Guardian

  Describes those with legal responsibility for a child. The term "person with parental responsibility" is used by the Human Tissue Authority.

   

• Participant

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

   

• Participant / Patient information sheet (PIS)

  The participant information sheet, in a form appropriate for the study population, explains what the research involves and how the research study will affect the participant. It is an important tool which helps support the consent process and is usually accompanied by a consent form.

   

• Peer review

  A system whereby research, or research proposals, are reviewed by independent experts to assure the quality of the research. For example:

      -  can the research design answer the question?

      -  does the research add to existing knowledge?

   

• Personal data

  In the context of the Data Protection Act 1998 personal data comprise information about living people who can be identified from that data, or from combinations of data and other information which the person in control of the data has, or is likely to have in future.

  To determine if the data you hold is personal data, please refer to the flowchart on pp6-7 of the Information Commissioner's Office What is personal data? – A quick reference guide.
  
  
  

• Personal information

  Refers to all information about individuals, living or dead. This includes written and electronic records, opinions, images, recordings, and information obtained from samples. Anonymised information, is not strictly speaking, personal information.

   

• Primary data

  Qualitative or quantitative data newly created or collected in the course of research. Sources may include independent experimental measurements or observations and information that has come from survey questionnaires, non-research documents (e.g. letters) or focus groups.

   

• Principal Investigator (PI)

  The Research Governance Framework defines the Principal Investigator as the leader responsible for a team of individuals conducting a study at a site. In a single site study the PI and the CI are likely to be the same person. (To avoid confusion the term Principal Applicant is being increasingly used to describe the lead investigator on a funding application).

   

• Proposal

  A proposal details the scientific and ethical reasons for research and should demonstrate conceptual innovation, methodological rigor and substantive content. The term is used to refer to a document produced to apply for funding.

   

• Protocol

  A research protocol is a written document demonstrating the necessity and feasibility of a particular study, as well as giving a detailed plan of how the study will be conducted, analysed and disseminated.

   

• Pseudonymised data / information

  Described under the Data Protection Act 1998 to mean where the normal personal identifiers have been replaced by an artificially-created identifier (or code) so as to conceal the identity of the patient. The links between the artificial and normal identifiers (or the cipher) are stored separately and securely, and so the data may still qualify under the Data Protection Act as personal data (i.e. if the cipher and the coded data are both held by the same organisation).
  
  

• R&D office / department

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

   

• Regulators or Regulatory Authorities / Agencies / Bodies

  A body that has a statutory role to ensure compliance with regulation. Their role is usually described within the relevant primary legislation or associated regulations. They may issues licences (e.g. Human Tissue Authority), approvals (e.g. HFEA) and will usually have an Inspection role.

   

• Related and unexpected serious adverse events

  NRES define this term as:

  A serious adverse event (SAE) occurring to a research participant which should be reported to the REC that gave a favourable opinion of the study (the 'main REC') where in the opinion of the chief investigator the event was: 

  • 'related' - that is, it resulted from administration of any of the research procedures; and
    
    'unexpected' - that is, the type of event is not listed in the protocol as an expected occurrence.

  A serious adverse event is an untoward and unexpected occurrence that:

      1.  results in death;

      2.  is life-threatening;

      3.  requires hospitalisation or prolongation of existing hospitalisation;

      4.  results in persistent or significant disability or incapacity;

      5.  consists of a congenital anomaly or birth defect.

   

• Relevant material

  In the Human Tissue Act 2004, 'relevant material' is defined as material, other than gametes, which consists of or includes human cells. In the HT Act, references to relevant material from a human body do not include:

  (a) embryos outside the human body, or

  (b) hair and nail from the body of a living person.

  See the HTA's Definition of relevant material for a more detailed explanation.

  Relevant material is different to Bodily material.

   

• Research Database

  The NRES definition of a Research Database is "a collection of data, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending".

   

• Research ethics committee (REC)

  Research Ethics Committees (RECs) are independent committees that review the ethical issues within research projects involving people as participants or their data or tissues. See the Ethical approval station for more information on the remit of RECs.

   

• Research Governance

  Research governance is a term that was first used in the UK Health Departments' Research Governance Frameworks. See 'NHS Research Governance Framework'.

  It is commonly used in a generic way to encompass the Research Governance Framework standards and principles, including all applicable regulatory requirements.

   

• Research Tissue Bank

  The HTA define a Tissue Establishment as a tissue bank or unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissue and cells are undertaken. It may also be responsible for procurement or testing or tissue and cells.

  A Research Tissue Bank could be described as organised entities that procure, store and distribute tissues samples for research purposes.

   

• Risk

  The likelihood of harm being caused by a hazard. The characteristics of risk include the probability of its occurrence, as well as the magnitude and duration. Harm may be to a research participant, a researcher or to the research itself.

   

• Safe Haven

  All secure points at which confidential information is received.  Organisations should ensure that there are procedures in place to ensure that personal information is received to a secure and protected point. All points of receipt should be considered i.e. transcribing of phone messages, fax in-trays, electronic mailboxes, pigeon holes and in-trays for paper information etc.

   

• Secondary data

  Data derived from use or analysis of primary data.  Often gathered or created by someone other than the primary data creator.  Secondary data can be generated for purposes different from those of the original research that produced the primary data.

   

• Secondary use

  Secondary use is where any data generated as the result of a research study is used for a purpose different from those of the original research.  Secondary use can use both primary and/or secondary data.

   

• Sensitive information

  Information that when used incurs a need for extra care, e.g. information about mental health, sexuality and other areas where revealing confidential information is especially likely to cause embarrassment or discrimination. According to the Data Protection Act 1998 'sensitive personal data' includes all information about physical as well as mental health or condition, or sexual life.

   

• Sensitive personal data

  In the context of the Data Protection Act 1998 'sensitive personal data' means personal data consisting of information as to:

  a)  the racial or ethnic origin of the data subject,

  b)  his political opinions,

  c)  his religious beliefs or other beliefs of a similar nature,

  d)  whether he is a member of a trade union (within the meaning of the Trade Union and Labour Relations (Consolidation) Act 1992),

  e)  his physical or mental health or condition, 

  f)  his sexual life,

  g)  the commission or alleged commission by him of any offence, or

  h)  any proceedings for any offence committed or alleged to have been committed by him, the disposal of such proceedings or the sentence of any court in such proceedings.
  
  

• Serious adverse event (SAE)

  NRES define a serious adverse event as an untoward and unexpected occurrence that:

      1.  results in death;

      2.  is life-threatening;

      3.  requires hospitalisation or prolongation of existing hospitalisation;

      4.  results in persistent or significant disability or incapacity;

      5.  consists of a congenital anomaly or birth defect.

  
  The HTA describe a serious adverse event as any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissue and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, or which might result in, or prolong, hospitalisation or morbidity.

   

• Source data verification

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

  Sometimes the research record will be the source data, e.g. for electronic questionnaire-based studies. In these situations mechanisms should be built in to ensure that checks are in place to minimise the chances of error when completing the questionnaire.

   

• Sponsor

  The sponsor is the individual, or organisation (or group of individuals or organisations) that take 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 Trial Regulations.

   

• Subject access

  The right of data subjects to receive a copy of the information held about them, a description of why their information is being processed, and details of anyone who may see a copy of their data, to whom it may be transferred, and the logic involved in any automated decisions taken on the basis of that data. Under the Data Protection Act 1998 research exemption, data subjects do not have a right of access to research data.

   

• System Level Security Policy

  The System Level Security Policy (SLSP) outlines how the organisation's confidentiality and security arrangements apply to a particular study. It is more specific than an organisational level policy. It covers the security and confidentiality measures across the whole duration of the study from data collection to analysis/onward disclosure. A template is provided on the NIGB website.
  
  

• Tissue bank

  See 'Research Tissue Bank'.

   

• Tissue sample

  See 'Human tissue/tissues or samples'.

   

• UKCRC

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

   

• Version control

  Version control is the management of multiple revisions to the same document. Version control enables users to tell one version of a document from another. Usually the latest approved version of a document is the one that should be used.