Contact

UK Office

Only Medics
33 Blagrave Street
Reading, Berkshire
RG1 1PW, UK

Tel -
+44(0)1189 522799

Email -
info@onlymedics.com

EU Office

Only Medics
11 - 12 Bouverie Street
London
EC4Y 8DP, UK

Tel -
+44(0)2078 221719

Share &
Connect


Keep connected & join the Only Medics Network here.

Only Medics LinkedIn Only Medics Facebook Only Medics Twitter
Clinical Professionals Pinterest Clinical Professionals YouTube Only Medics Google+
Pharmaceutical Jobs Integrated Regulatory Outsourcing Medical Communication Jobs
  • ABPI (ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY):

    The trade association for more than 75 companies in the UK producing prescription medicines.  It's member companies research, develop, manufacture and supply more than 80 per cent of the medicines prescribed through the National Health Service (NHS).  The ABPI also represents companies engaged in the research and/or development of medicines for human use. In addition, its general affiliate membership is for all other organisations with an interest in the pharmaceutical industry.

  • ABPI CODE OF PRACTICE:

    The aim of the ABPI Code of Practice is to ensure that the promotion of medicines is carried out in a responsible, ethical and professional manner. The Code incorporates the principles set out in international and European codes and the WHO ethical criteria for drug promotion.  Included in the Code’s scope are journal and direct mail advertising; activities of representatives including detail aids; supply of samples; provision of inducements whether in money or kind; provision of hospitality for promotional purposes; sponsorship of promotional meetings; sponsorship of scientific meetings including payment of travelling and accommodation expenses; all other sales promotion including exhibitions and the Internet. The Code also applies to a number of areas which are non-promotional, including information made available to the public about prescription only medicines.  The 2008 Code was published by the ABPI in June 2008.

  • ABPI/NHS R&D Model Agreement:

    The model is specifically for use in connection with contract clinical trials sponsored by pharmaceutical companies and carried out by NHS Trusts in England.

  • ACADEMY OF MEDICAL SCIENCES REPORT:

     Over the past decade, the Royal Society has taken a particular interest in the science associated with transmissible spongiform encephalopathy (TSE) diseases, which all appear to involve abnormal isoforms of prion related protein.

  • ADME  (ABSORPTION, DISTRIBUTION, METABOLISATION AND EXCRETION):

    describes the disposition of a pharmaceutical compound within an organism. The four criteria all influence the drug levels and kinetics of drug exposure to the tissues and hence influence the performance and pharmacological activity of the compound as a drug.

  • ADVERSE EVENT:

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See also SERIOUS ADVERSE EVENT.

  • ADR (ADVERSE DRUG REACTION):

    Before a medicine is granted a licence so that it can be made available in the UK, it must pass strict tests and checks to ensure that it is acceptably safe and effective.  All effective medicines, however, can cause side effects (also known as adverse drug reactions), which can range from being minor to being very serious.  For a medicine to be granted a licence, the expected benefits of the medicine must outweigh the possible risks of the medicine causing adverse effects. In the pre-approved clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.

  • AE (ADVERSE EVENT):

    See ADVERSE EVENT

  • AMRC (ASSOCIATION OF MEDICAL RESEARCH CHARITIES):

    The AMRC works to advance medical research in the UK. Its activities focus upon improving the effectiveness of the charitable sector in medical research.

  • ASCO (AMERICAN SOCIETY OF CLINICAL ONCOLOGY):

    The American Society of Clinical Oncology (ASCO) is a large professional organisation representing physicians who treat people with cancer. ASCO has professional members from more than 100 countries.

  • AUA (AMERICAN UROLOGICAL ASSOCIATION):

    The AUA strives to promote the highest standards of urological clinical care through education, research and in the formulation of health care policy across the United States.

  • AUDIT TRAIL: 

    An Audit Trail is a secure, time stamped record that allows reconstruction of the course of events relating to the creation, modification and deletion of an electronic study record.

  • BACKUP:

    see CancerBACKUP

  • BODMA (BRITISH ONCOLOGY DATA MANAGERS ASSOCIATION):

    BODMA was founded in 1987 to promote data management and trial co-ordination within oncology in the UK. Membership is open to anyone in oncology data management and/or trial co-ordination. Members work in a range of different settings, have a broad spectrum of job titles and responsibilities and include hospital data managers, trial coordinators, cancer registry data managers, research nurses, auditors etc.

  • BOPA (BRITISH ONCOLOGY PHARMACY ASSOCIATION):

    The stated purpose of BOPA, which is a registered charity, is "To promote excellence in the pharmaceutical care of patients with cancer through education, communication, research and innovation by an alliance of hospital, community and academic pharmacists, pharmacy technicians, those in the pharmaceutical industry and other healthcare professionals".

  • BPOS (BRITISH PSYCHOSOCIAL ONCOLOGY SOCIETY):

    The BPOS was established in 1984 to promote knowledge of the psychological and social aspects of cancer among professionals working with people with cancer.

  • CALDICOTT GUARDIAN:

    Caldicott Guardians are responsible for agreeing and reviewing internal protocols governing the protection and use of patient-identifiable information by the staff of their organisations.

  • CANCERGRID:

    The CancerGrid project will deliver modular, distributed software solutions for the key problems of clinical cancer informatics: clinical trial patient entry, randomisation and follow-up; storage and analysis of complex datasets; linking trial and epidemiology data with profiling information. It will facilitate trials management and future collaboration across international boundaries.

  • CANCER RESEARCH NETWORKS:

    The NCRN has increased involvement and recruitment into trials through the creation of 34 regional Cancer Research Networks across England, closely aligned to cancer service networks. NCRN funding is allocated to networks to appoint research staff, such as research nurses, data managers and medical staff sessions and to access pharmacy, pathology, radiology and other areas of support, such as information systems and training, all of which are integral to high quality research. Each network is required to appoint a clinical and administrative lead (Clinical Lead for Research and Research Network Manager) with responsibility for the overall leadership and management of the local networks.

  • CANCER RESEARCH UK:

    Cancer Research UK is the largest volunteer-funded cancer research organisation in the world. Cancer Research UK began operating in 2002 as a result of the merger between The Cancer Research Campaign and Imperial Cancer Research Fund. Cancer Research UK supports and undertakes a comprehensive programme of research in institutes, hospitals, universities and medical schools throughout Britain and Northern Ireland.

  • CANCER SERVICE NETWORKS:

    Cancer Service Networks are the organisational model for cancer services to implement the Cancer Plan with responsibility to develop an annual Strategic Service Delivery Plan, which is underpinned by workforce, education & training and facilities strategies. The objectives of the Network are to ensure that all commissioners and providers of cancer care, the voluntary sector and local authorities within the network work effectively together to deliver high quality care.

  • CANCER SERVICES COLLABORATIVE IMPROVEMENT PARTNERSHIP:

    (CSCIP) (Formerly known as the Cancer Services Collaborative): The CSC‘IP’ is a national NHS-funded programme developed to improve patient experiences of cancer services and clinical outcomes of care. The programme works to achieve its aims by examining service delivery and identifying where improvements can be made. The programme also aims to create learning for the wider NHS on improving care for people with cancer.

  • CANCERLINE UK:

    CancerlineUK is a resource website for cancer networks and multi-disciplinary teams (MDTs) working in primary and secondary care. The information on the website has been thoroughly researched and independently reviewed by recognised experts in the field of cancer. The site aims to offer a range of educational and informational services for improving the primary/ secondary care interface so that healthcare professionals have more time to focus on patient care. Patients and carers may also find the website of great value. The quality of its content and ease of use is likely to establish CancerlineUK as the premier reference site for turning NHS cancer strategy into improved patient care.

  • CANCERBACKUP :

    CancerBACKUP was launched as a national cancer information service in October 1985. It is a free information service providing information, practical advice and support.

  • CASE HISTORY:

    Case histories include the case report forms and supporting data, eg, signed and dated informed consent forms, any medical records. Case histories document patient informed consent obtained prior to participation in the study.

  • CASE REPORT FORM: 

    Case Report Form (CRF) is a record of clinical study observations and other information designated in a clinical trial protocol is completed for each study subject. A CRF can refer to either a CRF page, which denotes a group of one or more data items that are linked together for purposes of collection and display; a CRF casebook, which denotes the entire group of CRF pages on which a set of clinical study observations and other information plan to be or to have been collected or the information actually collected by completion of such CRF pages for a subject in a clinical study.

  • CD (CANDIDATE DRUG): 

    The process of drug discovery involves the identification of candidates, synthesis, characterisation, screening and qualitative/quanitative analysis for therapeutic efficacy. Once a compound has shown its value in these tests and potential to be developed into a successful and commercially viable product, pre-clinical results are submitted to health regulatory authorities and an application is made for permission to conduct Phase I clinical Trials in healthy volunteers.

  • CHM (COMMISSION ON HUMAN MEDICINES):

    The Medicines Healthcare products Regulatory Agency undertook a public consultation on proposals to amend the advisory body structure laid down in the Medicines Act 1968 in February 2004. Ministers agreed to a new structure with the establishment of the Commission that amalgamated the responsibilities of the Medicines Commission and the Committee on Safety of Medicines. The Commission was established under Section 2 of the Medicines Act 1968.

  • CHMP (COMMITTEE FOR HUMAN MEDICINAL PRODUCTS):

    EMEA’s Committee for Medicinal Products for Human Use replaced the Committee for Proprietary Medicinal Products (CPMP) in Spring 2004. CHMP comprises members nominated by the Member States and provides expert opinions which are enforced by the European Commission.

  • CLINICAL DATA:

    Data pertaining to the medical characteristics or status of a patient or subject.

  • CLINICAL PROTOCOL:

    A document describing a clinical study and how it is to be conducted. A protocol includes the objectives of the study, the study design, a description of the test article(s) and dosage, the experimental procedure, handling of adverse reactions, how the results will be analysed, consent and clearance provisions.

  • CLINICAL STUDY:

    See Clinical Trial.

  • CLINICAL TRIAL:

    Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or to identify any adverse reactions to an investigational product(s) and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or effectiveness for the development of medicines. This includes medical devices and other investigational products for which clinical data are required for approval to market. 

  • CLINICAL TRIAL PHASES:

    Phase I trialsThe initial introduction of a new drug or biologic into humans at a stage when only animal and in vitro data are available, these studies are often referred to as "clinical pharmacology". These studies are primarily designed to determine the metabolism, pharmacological action and safety of the drug in humans. More specifically, Phase I studies help to determine a safe dosage range of the drug in humans, provides information of drug absorption, distribution, metabolism, and excretion (ADME) and possibly early evidence of effectiveness. Review of data from Phase I is important prior to proceeding to Phase II clinical development.Phase II trialsThe first use of an investigational drug in humans to prevent or treat the disease for which it is intended. Close clinical monitoring is conducted on a relatively small number of subjects to determine the drug's short-term efficacy and its potential risks (safety).Phase IIa trialsFirst clinical studies in a small number of patients to demonstrate safety and first signs of efficacy.Phase IIb trialsInitial dose- ranging efficacy trials. They are more extensive than Phase IIa patient studies and are used to establish dose and overall efficacy/safety properties. These studies also establish the initial benefits to risk ratio. The results of these trials are used to determine the study design and dosing for Phase III trials.Phase III trialsExpanded, controlled and uncontrolled clinical trials intended to gather additional evidence of efficacy for specific indications being studied and to better understand safety and drug related adverse effects. Phase III trials are usually large multi-centre trials which collect substantial safety experience efficacy information and include the pivotal trials which serve the basis for drug approval. Phase III trials may also include specialised studies needed for labeling (e.g., pediatric or elderly, comparative agents). Several hundred to several thousand patients may be included in Phase III trials.Phase IIIb trialsStudies conducted after the drug has been submitted for marketing approval. The purposes of these studies include differentiation from other treatments, exploring use in additional patient populations, seeking new indications for the study, or exploring AEs. Results of these studies may be used to supplement a pending application.Phase IV trialsMarketing oriented trials, conducted after the drug has been approved for marketing. Study design may extend the recommended duration of treatment or they may be primarily instructive in nature to help familiarise a larger number of practitioners with the drug's efficacy and side effects.Pivotal trials Adequate and well-controlled Phase II and III trials which provide the substantial evidence of effectiveness and safety upon which the drug is approved.Post-marketing surveillance Clinical studies carried out by a company following market introduction to evaluate a new drug under conditions of actual medical practice. The studies may be initiated by the manufacturer to clarify why and how a new drug is used and determine whether the adverse experience profile established in controlled trials reflects the true properties of the drug. Such studies may also be required by a regulatory health authority as a condition for approval.

  • COCHRANE LIBRARY:

    Cochrane Reviews investigate the effects of interventions for prevention, treatment and rehabilitation in a healthcare setting. They are designed to facilitate the choices that doctors, patients, policy makers, and others face in health care. Most Cochrane Reviews are based on randomised controlled trials, but other types of evidence may also be taken into account, if appropriate.

  • CONFIDENTIALITY AGREEMENT:

    Legal agreement to protect confidential information revealed during discussions or negotiations with another party; applicable where either or both parties are individuals or an organisation. The agreement also contains protection against the copying or retention of confidential information; protection against disclosure to third parties of information not already in the public domainand remedy for any breach of the agreement.

  • COREC (CENTRAL OFFICE FOR RESEARCH ETHICS COMMITTEES):

    COREC works on behalf of the Department of Health in England to oversee arrangements for Research Ethics Committees and the Ethical Approval Process. For further information about how to apply for Ethics Approval, or to search the database of approved Research Ethics Committees.

  • CPMP (COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS):

    See CHMP

  • CRD (CENTRE FOR REVIEWS AND DISSEMINATION):

    The CRD was established in January 1994 at the University of York to provide the NHS with information relating to the effectiveness of treatments and the delivery and organisation of health care. CRD helps to promote research based practice in the NHS by offering rigorous and systematic reviews on selected topics; a database of good quality reviews; and a dissemination and an information service.

  • CRF (CASE REPORT FORM):

    A printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

  • CSM (COMMITTEE ON SAFETY OF MEDICINES):

    The Commission on Human Medicines was established to combine the functions of the Committee on Safety of Medicines and the Medicines Commission.

  • CTA (CLINICAL TRIAL AUTHORISATION):

    Regulations came into force on 1 May 2004 introducing new procedures for the authorisation of clinical trials.

  • CTAAC (CLINICAL TRIALS ADVISORY & AWARDS COMMITTEE):

    CTAAC will initially review applications for cancer trials as outline proposals. The exception to this will be finalised protocols of international studies and protocols submitted for peer review and endorsement by the Committee (See below). These may be submitted directly as a full proposal.

  • CTC: 

    Clinical Trial Certificate.

  • CTRC (CANCER THERAPY & RESEARCH CENTRE):

    CTRC aims to provide current and comprehensive multidisciplinary patient treatment, to devote time and resources to research that will facilitate the discovery of the causes, prevention, treatment and cure of cancer, and to promote cancer education and prevention practices. CTRC works in partnership with the University of Texas Health Science Centre and is a National Cancer Institute designated Cancer Centre.

  • CTRU (CLINICAL TRIALS RESEARCH UNIT):

    The Clinical Trials Research Unit at the University of Leeds is a leader in the field of clinical trials. The Unit conducts national and international randomised clinical trials in a variety of clinical fields (cancer, women and child health, cardiovascular disease, care of the elderly, mental health) and has an associated research portfolio. CTRU is one of the NCRI Accredited Trials Units.

  • CTX:

    Clinical Trial Certificate of Exemption.  Now incorporated into the Clinical Trial Authorisation.  See CTA.

  • DECLARATION OF HELSINKI:

    The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data. It was first adopted by the 18th WMA General Assembly in Helsinki, Finland, June 1964. It has since been amended 5 times at a succession of WMA General Assembly meetings, the latest of which the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Also there have been two notes of clarification provided since 2000.

  • DEPARTMENT OF HEALTH (DoH):

    The aim of the Department of Health (DH) is to improve the health and wellbeing of people in England. The website contains information, publications and links to other health related information sources.

  • DEPARTMENT OF HEALTH (NI):

    The Department of Health, Social Services and Public Safety was established by the Departments (NI) Order 1999. The Department’s mission is to improve the health and social well-being of the people of Northern Ireland.

  • DEPARTMENT OF HEALTH SCIENCE AND TECHNOLOGY COMMITTEE REPORT:

    CANCER RESEARCH – A FRESH LOOK. The Sixth Report of the Session 1999-2000 Cancer Research. Cm 5532, HMSO. A review of the cancer research in the UK and recommendations relating to the development of the National Cancer Research Network.

  • DIP PHARM MED (DIPLOMA IN PHARMACEUTICAL MEDICINE):

    Once in the pharmaceutical industry, many physicians aim to complete training for the Diploma in Pharmaceutical Medicine and gain Membership or Fellowship of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.

  • DISCOVERY MEDICINE:

    The molecular modelling of a broad spectrum of drugs followed by chemical and biological screening of the best products.

  • DRUG DEVELOPMENT:

    The program for advancing a drug compound generally from the pre-clinical decision to recommend a single compound in a research program through its approval for marketing by regulatory agencies.

  • ECCO (EUROPEAN CANCER CONFERENCE):

    ECCO is recognised as one of the world’s leading multidisciplinary cancer conferences and the European forum where the interaction between experimental and clinical oncologists and cancer nurses is the primary aim.

  • EMEA: 

    The European Medicines Evaluation Agency.

  • EORTC: (EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER):

    The EORTC was founded as an international organization under Belgian law in 1962 by oncologists working in the main cancer research institutes of the EU countries and Switzerland. It was named "Groupe Européen de Chimiothérapie Anticancéreuse" (GECA), and became the EORTC in 1968. Its aims are to conduct, develop, coordinate, and stimulate laboratory and clinical research in Europe to improve the management of cancer and related problems by increasing survival and improving patients' quality of life.

  • EUCTD: 

    (EUROPEAN UNION CLINICAL TRIALS DIRECTIVE)

  • EUDRACT: (THE EUROPEAN CLINICAL TRIALS DATABASE):

    EUDRACT is designed to be a register of all clinical trials in the Community, information on the content, commencement and termination of the clinical trials and on inspections.

  • EUDRAVIGILANCE:

    EudraVigilance is the European data-processing network and database management system for the exchange, processing and evaluation of Individual Case Safety Reports (ICSRs) related to medicinal products authorised in the European Economic Area (EEA).

  • EXCESS TREATMENT COSTS:

    Excess Treatment Costs are 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 alternative service. By definition, Excess Treatment Costs only arise where experimental services are being provided, or where standard care is being provided in a different way or location to routine practice.

  • EXCLUSION CRITERIA: 

    Items specified in a study protocol prohibiting subject participation in a clinical trial (e.g.medical restrictions, behavioral characteristics). See also INCLUSION CRITERIA.

  • FDA (FOOD AND DRUG ADMINISTRATION USA):

    FDA is the federal agency within the USA responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.

  • GCP (GOOD CLINICAL PRACTICE):

    See ICH-GOOD CLINICAL PRACTICE.

  • GENERIC MEDICINE: 

    Once a licence has been granted by the MHRA, a pharmaceutical company can then market a medicine under a brand name. The company then has exclusive rights to market the medicine for the licensed uses for a certain period of time, usually about 10 to 12 years. This is known as a patent and allows the company to recoup the costs of research and development of the new medicine, before other drug companies are allowed to produce it at a cheaper rate, because the R & D has already been done.  Once a patent expires, other companies then have the right to manufacture and market the drug but must market it under a different brand name, or under a generic name.

  • GENE THERAPY PRODUCTS: 

    Human gene transfer is the process of transferring genetic material (DNA or RNA) into a person. This technique is being studied to see whether it can treat certain health problems by either compensating for defective genes, prompting the body to make a potentially therapeutic substance, or triggering the immune system to fight disease. Somatic gene therapy encompasses medical interventions which involve the deliberate modification of the genetic material of somatic cells. The Gene Therapy Working Party Workplan gives guidance as to future directions and work on guidelines.

  • GMP (GOOD MANUFACTURING PRACTICE):

    GMP refers to principles and specifications for good manufacturing of medicinal products that are set by the Federal Therapeutic Goods Administration (FTGA), in accordance with international standards (known as Codes of GMP).  These are the standards manufacturers must comply with to provide safe and reliable products for consumers.

  • HTA (HEALTH TECHNOLOGY ASSESSMENT):

    HTA is one of the three main national programmes funded from the NHS R&D levy, the others being New and Emerging Applications of Technology (NEAT) and Service Delivery and Organisation (SDO). The purpose of the HTA programme is to ensure that high quality research information on the cost, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. "Health technologies" include all devices, equipment, drugs and procedures across all sectors of healthcare and is not confined to new drugs or pieces of sophisticated equipment.

  • HUMAN TISSUE AUTHORITY (HTA):

    The HTA regulates the removal, storage, use and disposal of human bodies, organs and tissue from the living and deceased.

  • ICH-GOOD CLINICAL PRACTICE (GCP):

     International Conference on Harmonization 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. GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights integrity and confidentiality of trial subjects are protected. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that clinical trial data are credible.

  • ICORG (IRISH CLINICAL ONCOLOGY RESEARCH GROUP):

    ICORG was established in October 1996. It is composed of specialists working in the oncology field who have the common goal of increasing the level of clinical cancer research in Ireland, to maintain and improve all forms of cancer treatment in the country.

  • ICR: 

    See INSTITUTE OF CLINICAL RESEARCH

  • IEC: 

    Independent Research Ethics Committee.

  • INFORMED CONSENT:

    The process by which a subject voluntarily confirms his/her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated Informed Consent Form.

  • INFORMED CONSENT:

    A document approved by a Review Board/ Ethics Review Committee that describes to a potential subject the aims, methods, anticipated benefits and potential hazards of an investigational study in a language he/she understands.

  • INCLUSION CRITERIA: 

    Essential characteristics the subject must have to be included in a clinical trial. See also EXCLUSION CRITERIA. Inclusion and Exclusion criteria define the study population.

  • INSTITUTE OF CANCER RESEARCH:

    The Institute of Cancer Research was established in 1909 to investigate the causes of cancer and develop new strategies for its prevention, diagnosis, treatment and cure. The Institute works with all the major cancer charities in the UK and is now a centre of excellence employing some of the world's leading scientists working on cutting edge research.

  • INSTITUTE OF CLINICAL RESEARCH (ICR):

    The Institute of Clinical Research (formerly ACRPI) has been in existence since 1978. The Institute encourages communication between all its members by supporting the various subcommittees and special interest groups and continues to fulfil its original goal of providing a forum for education and sharing of best practice amongst clinical research professionals.

  • INSURANCE INDEMNITY:

    Indemnity provides protection against any action by an individual, a group or an organisation that believe they received bad or negligent services, and incurred a loss as a result. Most professional bodies have professional indemnity cover; in some cases it is compulsory. The limit of an indemnity policy relates to the maximum amount of money that an individual or organisation will pay out in the event of a claim being made.

  • INVESTIGATIONAL MEDICINAL PRODUCT:

    An Investigational Medicinal Product is an active substance or placebo being tested or used as a reference in a clinical trial. It includes licensed medicinal products that are being used either off licence, within the licence but where the study involves assessing the efficacy and/or safety of the product, or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorisation.

  • INVESTIGATOR: 

    An individual qualified by training and experience (e.g., physician, dentist, clinical psychologist) to conduct a clinical study. He/she assumes direct responsibility for the welfare of subjects under his/her care, including the obligation to enroll subjects, to report adverse events, and to discontinue their treatment if there is real or anticipated danger.

  • INVOLVE:

    (Formerly Consumers in NHS Research). Involve aims to ensure that consumer involvement in R&D in the NHS, Public Health and Social Care improves the way that research is prioritised, commissioned, undertaken and disseminated.

  • KOL: 

    A Key Opinion Leader is a physician who influences peer medical practice and prescribing behavior.  Pharmaceutical companies engage key opinion leaders early in the drug development process to provide advocacy activity and key marketing feedback.

  • LEUKAEMIA RESEARCH FUND (LRF):

    LRF is a national UK charity devoted exclusively to improving treatments, finding cures and investigating the causes and prevention of cancers of the blood and related conditions in children and adults.

  • MAA (MARKETING AUTHORISATION APPROVAL): 

    Before a product is launched and doctors can prescribe it, a pharmaceutical company must apply (in the UK) to the MHRA for marketing authorisation.  Once authorisation is given, the product is ‘licensed’, ‘registered’ or ‘approved’.  All these terms mean the same thing.

  • MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004:

    The UK Statutory Instrument, which implement the requirements of EU Directive 2001/20/EC for Clinical Trials. It came into force on 1 May 2004.

  • MENTAL HEALTH RESEARCH NETWORK:

    The UK MHRN is a network designed to provide a research infrastructure. The network supports vital large-scale research which will help to raise the standard of mental health and social care research throughout England.

  • META REGISTER:

    The meta Register of Controlled Trials is a free, searchable, international database of more than 14000 ongoing randomised controlled trials in all areas of healthcare. At present, the mRCT also contains some completed trials.

  • MHRA (MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY):

    The MHRA is the Executive Agency of the Department of Health protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. The MHRA was formed from a merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) on 1 April 2003.

  • MONITORING: 

    The act of overseeing a clinical trial, and of ensuring that it is conducted, documented and reported in accordance with the protocol, standard operating procedures (SOP's), GCP and the applicable regulatory requirement(s).

  • MONITORING VISIT:  

    A visit to a study site to review the progress of a clinical study and to ensure protocol adherence, accuracy of data, safety of subjects and regulatory compliance.

  • MRC (MEDICAL RESEARCH COUNCIL):

    The MRC is a national organisation funded by the UK Government. It promotes research into all areas of medical and related science and is independent in its choice of which research to support, though it does work in close partnership with Health Departments, other Research Councils, industry and others to identify and respond to current and future health needs.

  • MRC-CTU (MEDICAL RESEARCH COUNCIL CLINICAL TRIALS UNIT):

    Formed by the amalgamation of the MRC HIV Clinical Trials Centre and MRC Cancer Trials Office it undertakes trials in a wide range of diseases. While maintaining a portfolio of high-quality research in cancer and HIV trials, it also undertakes research in areas such as rheumatoid arthritis, respiratory disorders, infectious diseases, and haematological disease. MRC CTU is one of the NCRI Accredited CTUs.

  • NATIONAL SERVICE FRAMEWORK FOR CANCER (NSF):

    The National Service Frameworks provide a policy framework for the commissioning of specific healthcare services. The NSF for Cancer, produced by the expert advisory group on cancer to the Chief Medical Officers of England and Wales, was published in April 1995 and outlined the direction in which cancer services in England and Wales should be developed. The National electronic Library for Health NSF Zones provide a gateway to the key sites and resources related to implementation of the NSFs for all health care practitioners and managers.

  • NBE (NEW BIOLOGICAL ENTITY): 

    This is a novel product where the active substance is a biological substance that has been produced or extracted from a biological source.  The production of biological medicinal products involves biological processes and materials, e.g. cultivation of cells or extraction of material from living organisms.

  • NCE (NEW CHEMICAL ENTITY): 

    This is a novel medicinal product where the active ingredient is a chemical substance that has been created or synthesised. Active ingredients which are ‘chemicals’ are created using physical and chemical manufacturing methods capable of a high degree of consistency (manufacture is reproducible).

  • NCCN (NATIONAL COMPREHENSIVE CANCER NETWORK):

    The National Comprehensive Cancer Network (NCCN), an alliance of 19 of the world's leading cancer centers, is an authoritative source of information to help patients and health professionals make informed decisions about cancer care. Through the collective expertise of its member institutions, the NCCN develops, updates, and disseminates a complete library of clinical practice guidelines. These guidelines are the standard for clinical policy in oncology.

  • NCI (NATIONAL CANCER INSTITUTE):

    The NCI is located in the United States and was established under the National Cancer Act of 1937. It coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

  • NCRI (NATIONAL CANCER RESEARCH INSTITUTE):

    The NCRI represents a formal partnership of the UK’s main cancer research funders (Medical Research Council, Cancer Research UK, Leukaemia Research Fund, Department of Health) and offers strategic coordination and leadership for cancer research conducted in the UK. The NCRN has been working closely with the NCRI on a range of common issues that impact on the quality and development of cancer research.

  • NCRI CLINICAL STUDIES GROUPS:

    The NCRI Clinical Studies Groups are a central component of the new framework for cancer research in the UK, providing the primary route through which new ideas for clinical trials are developed. At present 21 NCRI Clinical Studies Groups exist. 15 of the groups cover specific cancer sites, 5 are generic, a Consumer Liaison Group. The groups are funded by the major cancer charities and the MRC and are UK wide in their remit. They are charged with the development of national cancer clinical trials and the provision of tumour specific or task specific advice and work to a broad, but common, remit.

  • NCRN (NATIONAL CANCER RESEARCH NETWORK):

    The NCRN was established by the Department of Health in April 2001 to provide the NHS with an infrastructure to support prospective trials of cancer treatments and other well-designed studies and to integrate and support research undertaken by cancer charities. Its aim is to improve the speed, quality and integration of research, ultimately resulting in improved patient care. The NCRN will increase involvement and recruitment into trials through the creation of 34 cancer research networks across England, closely aligned to cancer service networks.

  • NCRN PORTFOLIO STUDY:

    An NCRN Portfolio study is any cancer clinical trial which is supported or funded by a member of the NCRI. Future trials funded or supported by these organisations will also become part of the Portfolio. In addition to NCRI-funded trials, it is recognised that there are a number of other well-designed local, national and international “non-NCRI trials” that have the potential to be part of the NCRN Portfolio (thus enabling access to NCRN infrastructure). The NCRN has established a process for the approval of non-NCRI trials for the inclusion in the NCRN portfolio.

  • NCTR (NATIONAL CANCER TISSUE RESOURCE):

    NTRAC led work on behalf of the NCRI to develop proposals for a National Cancer Tissue Resource (NCTR). The NCTR will facilitate research that advances cancer therapeutics and diagnostics from the laboratory to the clinic and will ultimately provide benefit for UK citizens. This initiative is an important development for cancer research and depends upon the willingness of surgical patients to engage with researchers to combat cancer by donating surplus surgical samples to the national resource.

  • NEAT (NEW AND EMERGING APPLICATIONS OF TECHNOLOGY):

    NEAT is one of the three main national programmes funded from the NHS R&D levy, the others being Health Technology Assessment (HTA) and Service Delivery and Organisation (SDO). NEAT supports work which applies recent advances in fundamental knowledge and technology to the development of new products and interventions for improved health and social care or for disease prevention and treatment.

  • NeLH (NATIONAL ELECTRONIC LIBRARY AFOR HEALTH):

    This website is a digital library designed for NHS staff, patients and the public. The website has a section about how clinical trials work and what people may expect if they are asked to take part in a one. The section was developed with patients and members of the public, and is designed for the people in the UK who might be asked to take part in a clinical trial during the course of their healthcare. This section does not provide information about specific trials.

  • NESC (NATIONAL ELECTRONIC SCIENCE CENTRE):

    e-Science refers to the large scale science that will increasingly be carried out through distributed global collaborations enabled by the Internet. Typically, a feature of such collaborative scientific enterprises is that they will require access to very large data collections, very large scale computing resources and high performance visualisation back to the individual user scientists.

  • NHS R&D FORUM:

    The NHS Research and Development Forum is an organisation for individuals and departments involved in the management and planning of R&D activities and in conducting R&D in health and social care. The purpose of the Forum is to improve the environment for research within organisations delivering health and social care by encouraging high standards and providing support and communication networks. The Forum is an inclusive organisation open to all involved in R&D, including directors, managers, administrators, consumers and researchers themselves. The activities of the Forum encompass research across the full range of health and social care including community and primary care, secondary and tertiary care, public health and social services.

  • NHSC (NATIONAL HORIZON SCANNING CENTRE):

    The National Horizon Scanning Centre (NHSC) aims to provide advance notice to the Department of Health in England and Wales of selected key new and emerging health technologies (including changing applications and uses of existing technologies) that might require urgent evaluation, consideration of clinical and cost impact or modification of clinical guidance.

  • NICE (NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE):

    NICE was set up as a Special Health Authority for England and Wales on 1 April 1999. It is part of the NHS, and its role is to provide patients, health professionals and the public with authoritative, robust and reliable guidance on current “best practice”. The guidance will cover both individual health technologies (including medicines, medical devices, diagnostic techniques, and procedures) and the clinical management of specific conditions.

  • NORMA (NATIONAL ONCOLOGY RESEARCH MANAGERS ASSOCIATION):

    This organisation was formed in October 2001. The group was established as a result of a need for mutual support for senior Research Nurses. The group plan to run workshops and training specifically on professional and managerial issues.

  • NTRAC (NATIONAL TRANSLATIONAL CANCER RESEARCH NETWORK):

    NTRAC, has been established to provide the facilities, skill and integration required to promote productive interactions between basic and clinical scientists, and to help to translate basic scientific research into clinical testing. It incorporates ten approved translational cancer research centres in England: Birmingham, Imperial College and University College in London, Leeds, Newcastle, Oxford, Royal Marsden, Southampton, Manchester and Cambridge. The NTRAC Coordinating Centre is based in Oxford.

  • OREC MANAGERS (MANAGERS FOR THE OFFICES OF RESEARCH ETHICS COMMITTEES):

    OREC Managers have been appointed in eleven English regions. Working with REC Leads in Strategic Health Authorities, they are responsible for leading the organisational development process in their area to ensure that the revised structure and arrangements for Research Ethics Committees are fit for purpose.

  • ORPHAN DRUGS/STUDIES:

    An orphan drug is any drug developed under the 1983 U.S. Orphan Drug Act, which concerns drugs for rare diseases such as those affecting less than 200,000 people in the US. This has been adopted as a subclause of the FDA. Developing a drug for these small groups would be financially unsound. Therefore, development of drugs for such diseases is rewarded by tax reductions and a monopoly for that drug for a limited time (7 years).

  • PARALLEL IMPORT: 

     Parallel importing is a legitimate trade in the EU and occurs when a product placed on the market in one country and is bought by an intermediary who then exports it to a second country. For parallel trade to exist, profits for the trader have to be sufficiently large to be attractive and occurs where there are significant price differences between countries.

  • PBSC (POPULATION AND BEHAVIOURAL SCIENCES COMMITTEE):

    The PBSC was established to provide an evidence base for effective strategies aimed at reducing cancer incidence, morbidity and mortality in the UK and elsewhere, in line with Cancer Research UK's Objectives, by funding internationally competitive research in cancer prevention and control and in behavioural research relevant to cancer.

  • PCTs (PRIMARY CARE TRUSTS):

    PCTs are free-standing, legally-established, statutory NHS bodies that are accountable to their Health Authority. PCTs have responsibility for securing the provision of the fuller range of services for the local populations. They have responsibility for all family health services practitioners allowing a coherent view of the development of all NHS services in the area. PCTs have responsibility for the management, development and integration of all primary care services including medical dental, pharmaceutical and optical.

  • PHARMACOVIGILANCE:

    Pharmacovigilance is defined as watchfulness in guarding against danger from drugs or providing for safety of drugs. It can also be a dedicated department whose role is to monitor toxicity and safety of drugs both in the developmental phase and post marketing.

  • PHASE: 

    Sequential evaluation of drugs/devices in humans.  See also CLINICAL TRIAL PHASES.

  • PIL: 

    A Patient Information Leaflet is supplied with medicines and contains information about medical conditions, available services and treatments.

  • PIPELINE: 

    A generic term used to describe the products a pharmaceutical company has in development at any one time.

  • PRINCIPAL INVESTIGATOR: 

    Investigator held primarily responsible for the clinical conduct of a study carried-out under his/her supervision.

  • PSUR  (PERIODIC SAFETY UPDATE REPORT):  

    A report at a defined time point after marketing authorisation and providing succinct summary information together with a critical evaluation of the benefit to risk balance of a product in the light of new or changing post-authorisation information. This evaluation ascertains whether further investigations need to be carried out and whether changes should be made to the marketing authorisation and/or to the product information.

  • QUALITY ASSURANCE: 

    Quality Assurance (QA) ensures that All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded) and reported in compliance with GCP and the applicable regulatory requirement(s).

  • RANDOMISATION: 

    The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

  • RAW DATA: 

    A researcher's records of patients, such as patient charts, hospital records, X-rays, and attending physician's notes. These records may or may not accompany an application to a Regulatory Authority but must be kept in the researcher's file.

  • REGULATORY AGENCY: 

    Many geopolitical entities have established agencies/authority responsible for regulating products used in healthcare. The agencies are collectively referred to as regulatory agencies or authorities.

  • RESEARCH FOR PATIENT BENEFIT WORKING PARTY REPORT:

    The Research for Patient Benefit Working Party was set up following the reports of the Biosciences Innovation and Growth Team (BIGT) and the Academy of Medical Sciences (AIMS). Its remit was to bring forward to ministers practical proposals for implementing the recommendations in the two reports.

  • SCOTLAND CANCER NETWORK:

    Three regional cancer networks have been established in Scotland to support Cancer in Scotland: Action for Change.

  • SDO (SERVICE DELIVERY AND ORGANISATION):

    SDO is one of the three main national programmes funded from the NHS R&D levy, the others being Health Technology Assessment (HTA) and New and Emerging Applications of Technology (NEAT). The SDO programme has been established to produce and promote the use of research evidence about how organisation and delivery of services can be improved to increase the quality of patient care, ensure better strategic outcomes and contribute to improved health.

  • SERIOUS ADVERSE EVENT: 

    Any adverse event occurring at any dose that results in any of the following outcomes: death, a life- threatening adverse experience, inpatient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalisation may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardise the patient or subject and may require medical or surgical intervention to prevent one.  See also ADVERSE EVENT.

  • SOPs: 

    See STANDARD OPERATING PROCEDURES.

  • SOURCE DOCUMENTS: 

    Original documents, data and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subject's diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, X-rays, subject files, and records kept at the pharmacy at the laboratories and at medico-technical departments involved in the clinical trial).

  • SPONSOR:

    The concept of a “Sponsor” for a clinical trial was introduced by the EU Clinical Trials Directive (2001/20/EC) and was adopted into the Department of Health’s Research Governance Framework for Health and Social Care for all clinical research. The definition of Sponsor for trials of investigational medicinal products (IMPs) is the individual, organisation or group of organisations/individuals that take responsibility for the initiation, management and financing (or arranging financing) for the study.  Sponsors of trials involving IMPs have specific legal responsibilities as specified in the EU Clinical Trials Directive and the UK’s Medicines for Human Use (Clinical Trials) Regulations 2004. For all other studies, (i.e. research that falls within the scope of the Research Governance Framework but that is not a trial of an IMP), the definition of sponsor is the individual, organisation or group of organisations/individuals that takes the lead in confirming that there are proper arrangements in place for the initiation, management, monitoring and financing of a study.

  • STANDARD OPERATING PROCEDURES: 

    Written instructions describing operations to be performed and methods employed to a prescribed standard.

  • STRATEGIC HEALTH AUTHORITIES (StHAs):

    From April 2002 there are 28 new Health Authorities, known as Strategic Health Authorities across England. Each StHA covers an average population of 1.5 million, the main functions of the new Health Authorities are to support PCTs and NHS Trusts in delivering the NHS Plan in their area; and to build capacity and support performance improvement across all their local health agencies.

  • STUDY CO-ORDINATOR: 

     An assistant to the Principal Investigator in a clinical study.

  • SuPaC (SUPPORTIVE AND PALLIATIVE CARE COLLABORATIVE):

    The NCRI Supportive and Palliative Care Research Collaborative is interdisciplinary. The Research Collaboratives scheme as a whole which includes SuPaC provides a source of dedicated funding (£5 million over five years) and will be funded by the Department of Health, Marie Curie Cancer Care, Macmillan Cancer Relief, Cancer Research UK and the Medical Research Council.

  • SUSAR (SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION):

    All adverse events that are suspected to be related to an investigational medicinal product and that are both unexpected and serious are considered to be SUSARs.

  • TRANSLATIONAL RESEARCH COMMITTEE

    The Translational Research Committee is responsible for developing a comprehensive portfolio of translational research for Cancer Research UK by: 1. Identifying opportunities for generating new knowledge in, and the subsequent development of novel therapeutic and diagnostic approaches 2. Providing the infrastructure and funding mechanisms to promote novel therapeutic and diagnostic developments 3. Pursuing partnerships with the wider academic and industrial community to deliver the strategic goals of the charity for translational research 4. Advising the Cancer Research UK Scientific Executive Board on the specific needs of the charity to improve its capacity, capability and performance in translational research.

  • TRICC (TRANSLATIONAL RESEARCH IN CLINICAL TRIALS)

    TRICC has been established to help ensure that well-designed translational studies are embedded within late phase cancer clinical trials. Their work includes reviewing funding applications and advising funders on the importance, quality and feasibility of translational research within clinical trials. They also conduct progress reviews once trials are underway. science.cancerresearchuk.org/gapp/fundingcommittees/tricc/tricc_tor.pdf

  • UKCCSG (UNITED KINGDOM CHILDREN’S CANCER STUDY GROUP)

    The UKCCSG began in 1977 with the aim of improving the management of children with cancer and advancing the knowledge and study of childhood cancers. Over 350 members represent all disciplines involved in the diagnosis and treatment of childhood cancers. The UKCCSG has 22 paediatric treatment centres within the UK. Coordination of the group's activities including registration of all cases of childhood cancer treated at its centres, and running a wide range of clinical trials, is managed by the Data Centre in Leicester. www.ukccsg.org

  • UKCRC (UNITED KINGDOM CLINICAL RESEARCH COLLABORATION)

    The purpose of the UKCRC will be to achieve effective and efficient translation of scientific advances into patient care, thereby improving national health and contributing to national wealth. The Cancer Networks model will now be extended to other disease areas covered by the UKCRC, with funding and research efforts targeted on diseases that place a high burden on the nation. ukcrc.org/

  • UKCRN (UNITED KINGDOM CLINICAL RESEARCH NETWORK)

    The UKCRN aims to improve the speed, quality and integration of research with the ultimate aim of improving patient care. The network will initially cover the existing NHS networks in cancer and mental health and new ones in the priority areas of medicines for children.

  • UKTMN (UK TRIAL MANAGERS NETWORK)

    The UK Trial Managers' Network (UKTMN) is a forum for the people who run UK publicly-funded 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. www.tmn.ac.uk/

  • WCTN (WALES CANCER TRIALS NETWORK)

    The WCTN was set up in April 1998 as a jointly funded collaboration between the Cancer Research Campaign (now Cancer Research UK) and the Welsh Assembly Government. The Network aims to support prospective trials of cancer treatments and other well-designed studies endorsed by government research councils, academic research groups and cancer charities. The WCTN aims to make research into improving treatments a more routine and acceptable part of high quality NHS care and to develop a research culture in the new cancer service in Wales. www.wctn.org.uk/home/index.htm

  • WTCRF (WELLCOME TRUST CLINICAL RESEARCH FACILITIES)

    Wellcome Trust Clinical Research Facilities are staffed, equipped and run specifically to promote high quality, GCP compliant, studies and novel research activities within an optimal NHS/academic environment. The facilities are located in Manchester, Edinburgh, North West Wessex, Birmingham and Southampton and have been funded by the Wellcome Trust. www.wtcrf.ed.ac.uk/education/

Job Search

Advanced job search

Register your C.V.