ABPI (Association of the British Pharmaceutical Industry): A trade association for UK pharmaceutical companies.
Adverse Drug Reaction (ADR): Any noxious and unintended response associated with the use of a drug in humans.
Adverse Event (AE): 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 (including an abnormal laboratory finding), symptom or disease temporarily associated with participation in the research project. The term has also been used to describe unfortunate events that may have serious consequences for the research project, e.g. breaking down of a freezer and loss of tissue samples.
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?.
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 Serious Unexpected Adverse Reactions ( SUSARs) and Serious Adverse Events (SAEs) that have occurred in subjects on that study in the past year.
Anonymised data / information: Anonymised data are data prepared from information from which the person to whom is relates cannot be identified. The term is used when referring to robustly pseudonymised / linked data or unlinked anonymised data.
Anonymised tissue: The Human Tissue Authority considers 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.
Approval conditions: Conditions to be met by the applicant prior to the start of the research. Approval conditions are issued by the REC with the final letter confirming a favourable ethical opinion. (Note: Approval conditions are distinct from the further information or clarification requested from the applicant when issuing a provisional opinion).
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. The retention of study files demonstrate the compliance of the investigator and sponsor with GCP and regulatory requirements. During archiving it should be ensured that documents and data are appropriately selected and stored in an area that is accessible but maintains the physical & logical integrity of the data over time, including security and authenticity. Periods of retention will depend on the nature of the research and sponsor?s and funder?s requirements.
ARSAC (Administration of Radioactive Substances Advisory Committee): Advises the Health Departments on written applications from practitioners for certificates which will enable them to use specific radioactive medicinal products in diagnosis, therapy or research.
Audit of Research: A systematic and independent examination of study related activities and documents, to determine whether the evaluated study-related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor's standard operating procedures (SOP's), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Audit trail: Documentation that allows reconstruction of the course of events.
Caldicott Guardian: A senior person responsible for protecting the confidentiality of patient and service-user information and enabling appropriate information-sharing.
Case Report Form (CRF): A Case Report Form is a paper or electronic form specifically used in clinical trial research to collect data from each participant.
Chief Investigator (CI): The investigator with overall responsibility for the research. In a multi-site study , the CI has co-ordinating responsibility for research at all sites.
Clinical Trial: A written description of a study of any therapeutic, prophylactic, or diagnostic agent conduct in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report.
Clinical Trial Authorisation (CTA): The regulatory approval for a clinical trial of an investigational medicinal product issued by the MHRA.
Co-Investigator: Any individual member of the trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows).
Competent Authority (CA): The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States.
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.
Confidentiality: The duty of persons to whom personal information has been given not to share the information with any unauthorised person.
Contract Research Organisation (CRO): 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.
CTIMP: Clinical trial of an investigational medicinal product.
CTU: Clinical Trials Unit
Custodian: The custodian is responsible for the safekeeping of data 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.
Database (research database): A collection of research data that is organised and allows its contents to be easily accessed, managed and updated. The type of database depends on the requirements of each 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.
Data Monitoring Committee (DMC): Group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing clinical trial.
Delegation Log: The purpose of this document is to provide a legal delegation of study specific principal responsibilities. Each member of study staff should sign to agree the acceptance of these, and each delegation should be signed by the Investigator.
DNA analysis: The Human Tissue Act (HTA) 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 Consent Code of Practice. This applies UK wide.
Eligible Studies: These are studies funded externally by a qualifying charity (one that subscribes to three qualifying standards - strategic direction, open access and quality assurance) that are eligible for support through NHS Support for Science monies.
Epidemiology: the study of factors affecting the health and illness of populations, and serves as the foundation and logic of interventions made in the interest of public health and preventive medicine. It is considered a cornerstone methodology of public health research, and is highly regarded in evidence-based medicine for identifying risk factors for disease and determining optimal treatment approaches to clinical practice.
Essential Documents: Documents that individually or collectively permit evaluation of the conduct of the study and the quality of data produced.
EUDRACT (European Clinical Trials Database): A database of all clinical trials commencing in the European Community since 1 May 2004. Established in accordance with the Medicines for Human use (Clinical trials) Regulations 2004.
European Medicines Agency (EMEA): 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.
Excess Treatment Costs: The difference between the Treatment Costs, incurred as a result of a particular piece of Research and Development, and those that would have been incurred had the patients concerned been receiving the standard care or service. By definition, Excess Treatment Costs only arise where experimental care or services are being provided, or where standard care or service is being provided in a different way or location to routine practice.
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.
Feasibility: a preliminary study undertaken to determine and document a trial/study's viability. The results of this study are usually used to make a decision whether or not to proceed with further trials/studies.
Funder: The Institution, Body or Individual(s) providing funding for the study (unless the Sponsor already covers this role) either through grants, contracts or donations.
Good Clinical Practice (GCP): Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
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. GMP is concerned with both production and quality control.
GTAC (Gene Therapy Advisory Committee): 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.
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.
Healthy volunteers: Persons recruited to and consenting to participate in research NOT by virtue of the fact they are a NHS patient with a specific condition, but rather as they represent normal, non-diseased physiology.
ICH-GCP (International Conference on Harmonisation ? Good Clinical Practice): A standard for the design, conduct, monitoring, recording, analysis and reporting of a study that gives 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.
Impartial witness: A person, who is independent of the trial, who cannot be unfairly influenced by the people involved with the trial, who attends the informed consent process if the subject or the subject?s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
Inclusion criteria: 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.
Independent Ethics Committee (IEC): An independent body (a review board or a committee, institutional, regional, national or supranational), constituted of medical / scientific professionals and non-medical / non-scientific members, whose responsibility it is to ensure the protection of the rights, safety and well being of human subjects involved in a trial and to provide public assurance of that protection, by among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Informed Consent: An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. Informed consent is an on going, interactive process rather than a one-time information session.
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.
Institutional Review Board (IRB): An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety, and well being of human subjects involved in a trial, by among other things, reviewing, approving and providing continuing review of the trial protocol and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Intellectual Property: The novel or previously undescribed tangible output of any intellectual activity. It has an owner, it can be bought, sold or licensed and must be adequately protected. It can include inventions, industrial processes, software, data, written work, designs and images.
Investigational Medicinal Product (IMP): A pharmaceutical form of an active substance or placebo being tested or used as a reference in a CTIMP. This includes products already with a marketing authorisation: when used or assembled (formulated or packaged) in a way different from the authorised form, when used for an unauthorised indication, or when used to gain further information about the authorised form.
Investigator's Brochure: A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.
Investigator Site File (ISF): 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.
IRAS (Integrated Research Application System): is a single system for applying for the permissions and approvals required for health and social care / community care research in the UK.
Medical devices: a trial/study to evaluate an object which is useful for diagnostic or therapeutic purposes. More specifically the EU Directive 2007/47/EC defines a medical device as "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
Medicines Assessment Research Unit (MARU): is the commercial "arm" of the R&D Directorate for NHS Grampian. The role of MARU is to liaise between sponsors and investigators in the process of negotiating contracts for commercial clinical trials and then to undertake the financial management of the trial for its duration.
Medicines and Healthcare products Regulatory Agency (MHRA): The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
Monitoring: The act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).
Multi-Centre Study: A study conducted at more than one site, by more than one investigator, but according to a single protocol.
National Research Ethics Service (NRES): A directorate within the National Patient Safety Agency and provides help and leadership for Research Ethics Committee's (RECs): formerly COREC (Central Office for Research Ethics Committees) in 2007.
NHS Research Scotland Permissions Coordinating Centre (NRSPermissionsCC): An initiative developed to streamline the process of obtaining approval for multicentre research studies in Scotland.
Patient Information Sheet (PIS): The PIS, in a form appropriate for the study population, explains what the research involves and how the research study will affect the participant. It is usually accompanied by a consent form. For guidance on preparing appropriate participant information sheets see NRES website.
Peer review: A system whereby research, or research proposals, are reviewed by independent experts to assure the quality of the research (e.g. can the research design answer the question? Does the research add to existing knowledge?).
Personal data: In the context of the Data Protection Act 1998 personal data comprise information about living people who can be identified from that data, or from combinations of data and other information which the person in control of the data has, or is likely to have in future. This includes written and electronic records, opinions, images, recordings and information obtained from samples, from which the person can be identified. The terms: confidential personal/patient data/information; identifiable personal/patient information/data; or identifiable confidential information, are used interchangeably and mean the same as personal data.
Pharmacovigilance: The pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.
Phase 1 Trial: The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or healthy volunteer subjects.
Phase 2 Trial: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.
Phase 2A Trial: Controlled clinical studies that occur after the completion of Phase 1 studies and the first set of exposure-response studies in patients, and before beginning Phase 2B (i.e. patient dose-ranging trial) and Phase 3 clinical efficacy-safety studies.
Phase 3 Trial: Studies are expanded controlled or uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labelling.
Phase 3B Trial: A subcategory of Phase 3 trials, done near the time of approval to elicit additional findings. These trials may be required as a condition of regulatory authority approval.
Phase 4 Trial: Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval.
Phase 5 Trial: Postmarketing surveillance is sometimes referred to as Phase 5. Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions.
Principal Investigator (PI): An individual who actually conducts a clinical investigation (i.e. under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
Protocol: Is a document that describes the objective(s), formal design, methodology, statistical considerations, and organisation of a research study. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. The protocol explains what will be done, when, how, and why. A particular study may be done by several researchers around the nation or around the world. Each researcher follows the same protocol so that at the end of the study information from all of the researchers can be combined and compared.
Quality Assurance (QA): All those planned and systematic actions that are established to ensure that the trial is performed and that data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s).
Quality Control (QC): The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.
Randomised Controlled Trial (RCT): A scientific procedure in which treatments are allocated to subjects at random, in order to eliminate bias. It is considered the most reliable form of scientific evidence because it ensures that different treatment groups are statistically equivalent.
Research Governance: A term that is first used in the UK Health Departments' Research Governance Frameworks. It is commonly used in a generic way to encompass the Research Governance Framework standards and principles, including all applicable regulatory requirements.
Regulatory Authorities: Organisations that ensure research is conducted in line with the law, e.g. such as the Human Tissue Authority, Medicines and Healthcare products Regulatory Agency.
Serious Adverse Event (SAE): An untoward medical occurrence that: results in death; is life-threatening; requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; consists of a congenital anomaly or birth defect.
Serious Unexpected Adverse Reaction (SUSAR): All suspected adverse reactions related to an investigational medicinal product (the tested investigational medicinal products and comparators) which occur in the concerned trial, and that are both unexpected and serious. For more detailed guidance please see Clinical Trials Tool Kit.
Site Specific Information (SSI): Section of the IRAS application form which contains questions specific to an individual research site and is for assessment by the relevant local REC. It is also used to apply to the local research site for R&D approval.
Source Data: All information in original records (and certified copies of original records) of clinical findings, observations or other activity in a clinical trial essential for the reconstruction and evaluation of the trial. Source data are contained in source documents.
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.
Source Documents: Original documents, data and records, e.g. medical records, subject files, laboratory notes and records, participants' diaries, pharmacy dispensing records, recorded data from automated instruments and x-rays.
Sponsor: An individual, organisation or group which takes responsibility for the initiation, management, and/or financing a research study.
Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.
Unexpected Adverse Drug Reaction: An adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.
United Kingdom Clinical Research Collaboration (UKCRC): The UKCRC is a partnership of organisations working to establish the UK as a leader in clinical research, by harnessing the power of the NHS.
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.
Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent, e.g. mental or physical incapacity.
Working Practice Document: A written methodology of how to conduct part of the research process, whilst not as formal as an SOP, it should be updated on a regular basis.