Any untoward medical occurrence in a participant, not necessarily causal relationship with medicinal product.
An Adverse Reaction is all untoward and unintended responses to an investigational medicinal product (IMP) related to any dose administered.
The remit of the College (of Life Sciences & Medicine) Ethics Review Board (CERB) is to provide a review of ethical aspects of any research proposal for projects on human volunteers or human tissue samples carried out by University staff and students within the college which are not covered by another committee e.g. the National Research Ethics Service or the Psychology Ethics Committee. For further information, see their website.
The Centre for Healthcare Randomised Trials is located in Health Services Research Unit (HSRU). A fully registered Clinical Trials Unit (CTU), its goal is to collaborate in high quality Randomised Controlled Trials (RCTs), providing access to the core competencies of experienced trialists, trial management, data processing and management, statistics, and health economics.
The Clinical Research Network is part of the National Institute for Health Research Clinical Research Network (NIHR CRN). The Clinical Research Network provides researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part. See here.
The College of Life Sciences and Medicine is one of the three colleges at the University; see http://www.abdn.ac.uk/clsm/. It is organised into three schools. HSRU sits within the Institute
of Applied Health Sciences (IAHS) and is part of the School of Medicine, Medical Sciences and Nutrition.
A Case Report Form is a paper or electronic form specifically used in clinical trial research to collect data from each participating site. Data on each patient participating in a clinical trial are held and/or documented in the CRF.
The named chief investigator (CI) takes responsibility for the conduct of the proposed research in the UK. The HRA’s policy is that the named CI should normally be a researcher who is professionally
based in the UK, so that he / she is able to supervise the research effectively in the UK setting and is readily available to communicate with the Research Ethics Committee (REC) and other review bodies during the application process and, where necessary, during the conduct of the research. Taken from http://www.hra.nhs.uk/resources/before-you-apply/roles-and-responsibilties/chief-investigator/
The Chief Scientist Office (part of the Scottish Government Health and Social Care Directorates) supports and promotes high quality research aimed at improving the services offered by NHSScotland, and the health of the people of Scotland. See their website for further details.
The Clinical Studies Oversight Group will review clinical research projects presented for Sponsorship to the University of Aberdeen or NHS Grampian. CSOG will also undertake an overview of Pharmacovigilance events, serious breaches and summary monitoring or audit reports of red graded findings at the regular meetings.
A Clinical Trial Authorisation is an authorisation from the MHRA to conduct a clinical trial.
The Clinical Trial Agreement is a document used between an Institute and an outside party to define the terms and conditions associated with the conduct of a clinical trial.
A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, in that it tests the safety or efficacy of an investigational medicinal product.
Clinical Trials Unit; are specialised research units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials, cluster randomised trials, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial. See here for this definition.
Within a trial context, a data coordinator provides data management and secretarial support for trial research staff. This role includes responsibility for data entry and data cleaning, liaising with health professionals in trial sites, organising trial meetings and acting on any queries about the trial.
The DMC is a committee whose role is to review the accruing trial data and to assess whether there are any safety issues that should be brought to participants' attention or any reasons for the trial not to continue. The Data Monitoring Committee should be independent of both the investigators and the funder/sponsor and should be the only body that has access to unblinded data. It normally makes recommendations to the Trial Steering Committee (or Trial Management Group).
A Data Management Plan describes and defines all data management activities for a study. Some examples of the essential ingredients for a DMP are: a map of file server arrangements; details of study personnel involved with the study and data access roles assigned to each; a complete set of finalised case report forms (CRF); database design; software, hardware and database location; data flow and tracking to ensure optimal data completion and to facilitate reporting; data entry procedures; Quality Assurance plan, for example audit trail checks; archiving and security arrangements.
Personal information (including patient and staff information) relating to living individuals held on a computer or manual system is safeguarded by the Data Protection Act 1998. This places obligations on those who record or use information, while at the same time giving specified rights to people about what information is held. The Act protects the right of the individual about what information is obtained, shared, processed or supplied whether via a computer or manual paper records.
The Declaration of Helsinki is a statement of ethical principles developed by the World Medical Association to: "provide guidance to physicians and other participants in medical research involving human subjects"
One of the research programmes in the Health Services Research Unit (HSRU). Its research has potential to inform improvements in the way that health care is delivered. See the DOC web page for further information.
The Development Safety Update Report (DSUR) Guidance (ICH E2F) was published in the EU in September 2010 and has been implemented in September 2011 (EMA/CHMP/ICH/309348/2008). For CTIMPs, sponsors are required to submit a safety report to the MHRA and the Ethics Committee, once a year throughout the clinical trial or on request. The annual safety report should take into account all new available safety information received during the reporting period.
The Division of Applied Health Sciences in the School of Medicine, Medical Sciences and Dentistry is the administrative home of University members of the Institute of Applied Health Sciences.
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. The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.
EudraCT is the Clinical Trial application and database. All clinical trials require a EudraCT number to uniquely identify the study which is allocated by the European Agency for the Evaluation of Medicinal Products (EMEA).
EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse drug reactions (ADRs) during the development, and following the marketing authorisation of medicinal products in the European Economic Area (EEA).
The EUCTD (2001/20/EC) is a legal document, published in 2001, which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. The EU GCP Directive 2005/28/EC supplements the EUCTD, strenthening the legal basis for requiring Member States to comply with the principles and guidelines of good clinical practice, as set out in the ICH GCP guidelines.
This glossary aims to facilitate informed choices about treatments by promoting consistent use of plain language and providing plain language explanations of terms that people might need to understand if they wish to assess claims about treatments.
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. Compliance with this standard provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
The Health and Social Care Research and Development (HSC R&D) Division is part of the Public Health Agency.
The national provider of information, data and IT systems for health and social care. See website.
The HRA was established in December 2011 to protect and promote the interests of patients and the public in health research, and to streamline the regulation of research. They are responsible for a wide range of projects to streamline research, and host IRAS.
The Health Services Research Unit, part of the University of Aberdeen, has a national remit to research the best ways to provide health care, and to train those working in the health services in research methods. Most research projects aim to find out whether developments within the health service really are effective, efficient and appropriate.
The IAHS conducts population-based research into the need for, access to, evaluation of, and delivery of healthcare. See the IAHS website for more details.
Interactive Voice Response Systems, used for Patient Randomisation, allows study administrators and investigators to interact with a computer database using a telephone touchtone keypad as a means of data input. The computer is able to prompt the caller for required information with straightforward pre-recorded voice messages and give out information in response. This service randomise treatments to subjects, provide automated confirmation of assignments, as well as regular reporting of trial progress to the researcher. All this is done on a 24/7 basis, eliminating the issues of time-zones and distance.
The ICMJE is a small group of general medical journal editors and representatives of selected related organizations working together to improve the quality of medical science and its reporting.
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (known as International Conference on Harmonisation before 23 October 2015) brings together the regulatory authorities of Europe, Japan and the United States to discuss scientific and technical aspects of product registration. It makes recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration to reduce or avoid the need to duplicate the testing carried out during the research and development of new medicines. See the ICH website for further information.
The ISRCTN is a numeric system for the identification of clinical trials worldwide. The randomly generated, eight-digit ISRCTN is unique to a registered trial, thereby ensuring that the trial can be simply and unambiguously tracked throughout its lifecycle from initial protocol to results publication. The ISRCTN website provides further information.
Integrated Research Application System is a web-based integrated system for research applications. It is designed to capture information needed to be submitted by researchers for the relevant permissions and approvals (including NRES & NHS R&D approval) to enable the conduct of health and social care research in the UK. It streamlines the application process by allowing you to enter your study information in one place without duplication in separate application forms for each review body.
The Investigational Medicinal Product Dossier is the basis for approval of clinical trials by the competent authorities in the EU. The IMPD includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study have to be part of the IMPD. Taken from http://www.impd.eu/
A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product (IMP) which are relevant to the study of the product in human subjects. See http://ichgcp.net/7-investigator%e2%80%99s-brochure for full details.
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.
Lunchtime Research Meetings provide the opportunity for the dissemination of research activities between academic colleagues. and include both internal and external speakers.
The Managed Clinical Network is a linked group of health professionals and organisations from primary, secondary and tertiary care, working in a co-ordinated manner, unconstrained by existing professional and Health Board boundaries, to ensure equitable provision of high quality clinically effective services throughout Scotland.
The Medicines and Healthcare products Regulatory Agency is a government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. See their website for further information.
The Medicines for Human Use (Clinical Trials) Regulations 2004 regulate clinical trials in the UK since they came into force on the 1 May 2004. They replace the current clinical trial provisions of the Medicines Act 1968 and its secondary legislation and will transpose Directive 2001/20/EC1into UK law. See also subsequent amendment 2006/1928.
The Medical Research Council is a publicly-funded organisation dedicated to improving human health. The MRC supports research across the entire spectrum of medical sciences, in universities and hospitals, in our own units, centres and institutes in the UK, and in our units in Africa.
The model agreement for non-commercial research is a template for documenting the relationship between, and the responsibilities of, non-commercial sponsor(s) of a research study and the Health Service organisation where the study takes place. This document is currently under review. See: http://www.ukcrc.org/regulation-governance/model-agreements/mnca/
To help facilitate a high standard of research across the Institute, the IAHS has a Monitoring and Audit Group (MAGI). MAGI reviews research conducted within IAHS, with a view to assuring its quality and rigour, and identifying any issues that need to be addressed by the IAHS. MAGI personnel conduct periodic inspection of facilities, audits of studies in progress and checks on staff training and competence. The audit is based on a system (the IAHS Research Governance and Quality Assurance Policy (RGQAP)), and therefore the aim of the audit is to identify or prevent deficiencies in the system.
The National Institute for Health and Care Excellence provides national guidance and advice to improve health and social care.
The National Institute for Health Research Clinical Research Network Coordinating Centre supports clinical research and helps to facilitate the conduct of trials and other well-designed studies within the NHS. See NIHR CRNCC website for further information.
The NIHR Research for Patient Benefit Programme (RfPB) is a national, response-mode programme inspired by patients and practice to generate high-quality research for the benefit of users of the NHS in England. See website for further information.
Health and Care Research Wales is a national organisation funded and overseen by the Welsh Government’s Research and Development Division. See website for further information.
'The National Research Ethics Service has a dual mission. To protect the rights, safety, dignity and well-being of research participants and to facilitate ethical research which is of potential benefit to participants, science and society.' NRES is now part of the Health Research Authority (HRA); see HRA website for further information.
NHS Education for Scotland is an education and training body and a special health board within NHS Scotland, with responsibility of developing and delivering education and training for the healthcare workforce in Scotland.
NRS Permissions CC manages the process of obtaining R&D NHS management permission for multicentre research projects in Scotland. NRS Permissions CC liaises directly with NHS Board R&D offices to help streamline the Scottish R&D permissions process. For further information see the NRS Permissions CC website.
Please see website for further details.
Please see website for further details.
The NIHR has issued a new Implementation Plan for the NIHR Office for Clinical Research Infrastructure. The NOCRI, established in December 2009, helps to facilitate collaborations between NIHR-funded infrastructure and funders of research, including industry. The plan is available here.
The Grampian Research Ethics Committees (REC) became the North of Scotland Research Ethics Service covering Grampian, Highlands and Islands, Orkney and Shetland. Please see the website for further details or email on firstname.lastname@example.org.
Patient or Participant Information Leaflets are leaflets which are given to patients / participants and, in the context of a trial or study, describe the purpose of the trial or study, which treatments or interventions are being studied along with any advantages and disadvantages, the role of participants in the trial/study and what they will be asked to do, and the safeguards in place to protect the interests of the patient/participant.
The Principal Investigator is the investigator responsible for the research site where the study involves specified procedures requiring Site Specific Assessment (SSA). There should be one PI for each research site. In the case of a single-site study, the chief investigator and the PI will normally be the same person. Taken from http://www.hra.nhs.uk/resources/before-you-apply/roles-and-responsibilties/principal-investigator/
A Project Management Group consists of a trial's grant holders, those responsible for the day-to-day management of the trial (usually the trial manager) and can include a consumer representative (if these persons are not grant holders).
PPI is used as an umbrella term to cover a multiplicity of interactions that patients and the public have with the NHS. When thinking about PPI in research INVOLVE (http://www.invo.org.uk) 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, undertaking interviews with research participants.
Qualified person is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). Article 49 of the Directive defines a Qualified Person.
A QALY is a year of life adjusted for its quality or its value. A year in perfect health is considered equal to 1.0 QALY. The QALY is often used in cost-utility analysis to calculate the ratio of cost to QALYs saved for a particular health care intervention.
Quality Assurance is defined as those planned and systematic actions that are established to ensure that the work performed and the data generated, documented (recorded), and reported is in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
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.
A Randomised Controlled Trial is a study in which the participants are randomly allocated, by chance, to receive one of several clinical interventions.
R&D approval provides permission for a study to commence within the NHS and is required for all research studies involving NHS patients, their tissues or information, or studies involving NHS staff participating by virtue of their profession. For further information, see NHS R&D Forum. For local information please see NHS Grampian R&D.
The Research Ethics committee is an independent body constituted by medical/scientific professionals and non-scientists members, whose responsibility is to ensure the protection of rights, safety and wellbeing of subjects involved in clinical trials.
Research Governance can be defined as the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.
The Research Governance Framework for Health and Social Care sets out the broad principles of good research governance. In Scotland, the first edition for the Research Governance Framework for Health and Community Care in Scotland was issued in 2001. The current version was issued in February 2006. The Health Research Authority (HRA) and the devolved administrations are developing a new UK Policy Framework. That version is intended to be published in summer 2016, replacing the Research Governance Frameworks previously issued by each of the UK Health Departments.
The Research Passport is a streamlined system for issuing honorary research contracts to researchers who do not have a contractual relationship with the NHS. The Passport benefits researchers, NHS organisations and universities because it: promotes the consistent use of honorary research contracts by the NHS; provides clear guidance on their use; provides a streamlined standard system to apply for the contracts; avoids repeat checks for each contract; and, clarifies responsibilities of NHS hosts and Higher Education Institution employers. Please see the UK Clinical Research Collaboration website for further details.
The Research Nurse is usually involved in the clinical care aspects of the study, but may also be involved in trial co-ordination, which can be a significant proportion of the role.
For non-commercially sponsored studies the Health Research Authority (HRA) is testing the use of Schedule of Events and Statement of Activities templates to capture all information around study activities being undertaken at a local level. For further information please see the HRA website.
The Scottish Intercollegiate Guidelines Network (SIGN) develops evidence based clinical practice guidelines for the National Health Service (NHS) in Scotland.
The Scottish Medicines Consortium analyses information supplied by medicine manufacturers on the health benefits of their medicine and justification of its price. As the NHS has limited resources, SMC works to make sure that those medicines which represent good value for money are accepted for routine use as quickly as possible so that they can benefit patients.
Any medical occurrence is 'serious' if it: results in death; is life threatening; requires or prolongs inpatient hospitalisation; results in persistent/significant disability/incapacity; or, is a congenital anomaly/birth defect.
Serious adverse event that is judged by the investigator to have a reasonable causal relationship to the investigational medicinal product (IMP).
Serious breach is a breach which is likely to affect to a significant degree: the safety or physical or mental integrity of the subjects of the trial; or the scientific value of the trial.
Source document/data verification is the substantiation of data collected in a research study, for example a case report form (CRF), by looking at its primary source, for example medical records.
Site-specific assessment is a local assessment of the suitability of a local site, facilities and research staff to undertake a previously approved multi-centre study. This is usually undertaken by a local REC or R&D Office.
An SSI is a form used to apply both for site-specific assessment and R&D approval at NHS sites (except in Northern Ireland, where separate arrangements will be in place for R&D applications).
Standard Operating Procedures are detailed written instructions to achieve uniformity of the performance of a specific function. A comprehensive set of well maintained SOPs (or Best Practice Guidelines) is essential to research in order to comply with the various guidelines and regulations as well as to ensure that the delivery of the research is of a high quality.
Standard Protocol Items: Recommendations for Interventional Trials is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol. See SPIRIT website.
A document containing a detailed elaboration of the principal features of the analysis described in a clinical trial protocol, and which includes procedures for statistical analysis of the primary and secondary variables and other data.
Embedded studies within reviews and trials. These studies aim to make full use of an existing review or trial by embedding an additional study into them. The results can be reported and the study concepts are free for anyone to use or adapt, data from these embedded studies is often pooled from multiple trials. For further information, please see study website.
The basis of information for health professionals on how to use a 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. For further information see here.
An adverse reaction, classed as serious and suspected, the nature and severity of which is not consistent with the applicable product information (e.g. Investigator's Brochure if unlicensed; SmPC if licensed).
A Trial Manager is responsible for the overall day-to-day management of a trial. This role is wide ranging and includes the supervision of trial team members, monitoring of trial budgets, adherence to legislative, contractual and ethical requirements, and the preparation and publication of data. For further information, please see UKTMN.
A Trial (or Study) Master File is a collection of the essential documents, which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents will include: documented favourable opinion of ethics committee of protocol, informed consent, case report forms etc; financial aspects of the trials; R&D approval.
The Trial Steering Committee is a committee whose role is to monitor and supervise the progress of the trial and ensure that it is being conducted in accordance with the principles of GCP and the relevant regulations. The Trial Steering Committee should agree the trial protocol and any protocol amendments and provide advice to the investigators on all aspects of the trial. A Trial Steering Committee may have members who are independent to the investigators, in particular an independent chairperson. Decisions about continuation or termination of the trial or substantial amendments to the protocol are usually the responsibility of the Trial Steering Committee.
In software development, user acceptance testing (UAT) is a phase of software development in which the software is tested in the "real world" by the intended audience.
The UK Trial Managers' Network is a forum for the people who run UK trials. Its primary functions are to link trial managers together to ensure the sharing and dissemination of expertise and experience and to provide training tools developed by the members of the network to new trial managers. Please see their website for further details.
The Unit Staff Meeting is the main forum for discussion of any matter; research, academic or domestic, which affects the day-to-day or longer-term running of the Unit. It is also the main information giving/receiving forum for all staff.
A Working Practice Document is a locally controlled document providing specific instructions or further information on a particular task.