Glossary
This page provides a quick reference guide for acronyms and terms commonly used in relation to research governance and health and social care research.
Glossary of terms
A >> D
| Entry | Detail |
|---|---|
| A | |
| ABPI | Association of the British Pharmaceutical Society |
| ACDM | Association of Clinical Data Managers |
| Adult | A person who has attained the age of 16 years |
| AE | Adverse Event - Any untoward medical occurence in a person involved in a clinical study to whom a medicinal product has been administered, including occurences which are not necessarily caused by or related to the product. |
| Allogenic | Being genetically different although belonging to or obtained from the same species, e.g. human donor cells |
| AR | Adverse Reaction - Any untoward or unintended response in a person involved in a clinical study to a medicinal product, which is related to any dose administered to that person |
| Authorised REC | A Research Ethics Committee established under the Governance Arrangements for Research Ethics Committees but not recognised by UKECA. An authorised REC may review all applications except those relating to clinical trials of investigational medicinal products |
| Autologous | Derived or transferred from the same individual's body |
| B | back to top |
| Blinding | A procedure in which one or more parties involved in a trial are kept unaware of the particular courses of treatment being employed. |
| BMA | British Medical Association |
| C | back to top |
| CA | Competent Authority |
| Care Professional | See 'Health Care Professional' further down below |
| CAS | Central Allocation System |
| CI | Chief Investigator - The person with overall responsibility for a research study. For multi-site studies there will also be principal investigators at each research site who have responsibility for the study at that site. |
| Clinical Trial (legal, regulatory definition) | Any investigation in human subjects, other than a non-interventional trial, intended to: * discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products * identify any adverse reactions to one or more such products * study absorption, distribution, metabolism and excretion of one or more such products |
| Comparator | A product used as a reference in a clinical trial. |
| COREC | Central Office for Research Ethics Committees |
| CRF | Case Report Form - A printed or electronic document which records all of the information required in the protcocol about each trial subject that needs to be reported to the sponsor. |
| CRO | Contract Research Organisation |
| CTA | Clinical Trial Authorisation; Clinical Trials Agreement; Clinical Trial Administrator |
| CTD | Clinical Trials Directive |
| CTIMP | Clinical Trial of an Investigational Medicinal Product |
| CTR | Clinical Trial Report |
| D | back to top |
| Declaration of Helenski | The Declaration of Helsinki adopted by the World Medical Association in June 1964, and subsequently amended. See our section on the Declaration for more information |
| Domain | The area covered by a Strategic Health Authority (England), a Health Board (Scotland), a regional office of the NHS Wales Department or the whole of Northern Ireland |
E >> L
| Entry | Detail |
|---|---|
| E | |
| EMEA | European Medicines Agency |
| Essential Documents | Documents which individually and collectively permit evaluation of the conduct of a research project/trial and quality of the data produced |
| EudraCT | European Clinical Trials Database |
| EudraVIGILANCE | European Database for Pharmacovigilance |
| Ex vivo | In an artificial environment outside the living organism. |
| F | back to top |
| FDA | Food and Drug Administration |
| G | back to top |
| GCP | Good Clinical Practice |
| GMC | General Medical Council |
| GMP | Good Manufacturing Practice |
| H | back to top |
| Health Care Professional | A doctor, dentist, nurse, pharmacist or registered opthalmic optici an or other officially registered health professional |
| I | back to top |
| ICH | International Conference on Harmonisation |
| IMP | Investigational Medicinal Product - A pharmaceutical form of an active substance or placebo being tested, used or to be used, as a reference in a clinical trial. It includes a medicinal product which has a marketing aut horisation but is, for the purposes of the trial: * used, formulated or packaged in a way different from the form of the product authorised under the authorisation * used for an in dication not included in the summary of product characteristics under the authorisation for the product * used to gain further information about the form of that pr oduct as authorised under the authorisation |
| Informed Consent | Consent that a person has agreed to take part in a clinical study where the decision is: * given freely after that person is informed of the nature, significance, implications, inconveniences and risks of the study and is either: - evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate consent, or - if the person is unable to sign or mark a document so as to indicate consent, is given orally in the presence of at least one witness and recorded in writing. The subject should also be informed of his or her right to withdraw from the study at any time. |
| In vitro | In an experimental situation outside the organism, e.g. biological or chemical work done in a test tube (in vitro is Latin for "in glass") rather than in living systems. |
| In vivo | In a living cell or an organism. |
| Investigator's Brochure | A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects. |
| ISRCTN | International Standard Randomised Controlled Trial Number |
| J | |
| K | |
| L | back to top |
| LREC | Local Research Ethics Committee |
M >> R
| Entry | Detail |
|---|---|
| M | |
| Main REC | In the case of multi-site studies, the REC undertaking the ethical review of an application. The main REC may be a LREC or a MREC |
| Manufacturing Authorisation | MA - An authorisation to manufacture, assemble or import an investigational medicinal product which has been granted by the licensing authority (the MHRA) |
| MHRA | Medicines and Healthcare Products Regulatory Agency |
| Minor | A person under the age of 16 years |
| MREC | Main or Multi-centre Research Ethics Committee |
| N | back to top |
| NHS R&D | National Health Service Research and Development |
| Non-interventional trial (legal, regulatory definition) | A study of one or more medicincal products which have a marketing authorisation, where the following conditions are met: * the products are prescribed in the usual manner in accordance with the terms of that authorisation * the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice * the decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study * no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question * epidemiological methods are to be used for the analysis of the data arising from the study |
| O | |
| P | back to top |
| PI | Principal Investigator - The investigator responsible for a research site where the study involves specified procedures requiring site-specific assessment. There should be one PI for each research site. In the case of a single-site study, the Chief Investigator and PI will normally be the same person. |
| PIAG | Patient Information Advisory Group |
| Protocol | A document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial. |
| Q | back to top |
| QA | Quality Assurance |
| QC | Quality Control |
| Qualified Person (QP) | The person responsible for the final despatch of an investigational medicinal product in a clinical trial. They may be required, for example, to certify that: * a product has been manufactured in the UK in accordance with Good Manufacturing Practice (GMP), or * an overseas manufacturing site operates in accordance with standards equivalent to EU GMP. |
| R | back to top |
| REC | Research Ethics Committee |
| Recognised REC | A Research Ethics Committee legally recognised by the UK Ethics Committee Authority (UKECA) to give an ethical opinion on a clinical trial of an investigational medicinal product to be undertaken anywhere in the UK. |
S >> Z
| Entry | Detail |
|---|---|
| S | |
| Serious Adverse Event (or serious adverse reaction or unexpected serious adverse reaction) | Any serious adverse event, reaction or unexpected adverse reaction that: * results in death * is life-threatening * requires hospitalisation or prolongation of existing hospitalisation * results in persistent or significant disability of incapacity * consists of a congenital anomaly or birth defect |
| SHA | Strategic Health Authority |
| Site Specific Assessment | SSA - An assessment, under the NHS REC s ystem, of the suitability of the investigator, site and facilities made for any study with a Principal Investigator at each research site. (The application should be made by the PI using Part C of the COREC application form. See our page on How to Apply for NHS REC Approval for more information) |
| SOP | Standard Operating Procedure |
| Sponsor | The organisation that takes responsibility for the initiation, management and financing of a clinical study. For more information, see our sections on the sponsor and the sponsor agreement process. |
| SSAR | Serious Suspected Adverse Reaction |
| Subject | An individual, whether or not a patient, who participates in a clinical study. They may be a recipient of a treatment/product or be involved without this, as a control. |
| SUSAR | Suspected Unexpected Serious Adverse Reaction |
| T | back to top |
| Trial Master File (TMF) | A standard, central, orderly filing system which allows the effective storage and location of the large volume of regulatory and approvals documents needed for clinical research. The regulatory documents within the TMF should be maintained alongside case report forms and source documentation. The system could be in the form of a single project file or a number of files/filing cabinets, depending on what is deemed most appropriate. |
| TSC | Trial Steering Committee |
| U | back to top |
| UKCRC | United Kingdom Clinical Research Collaboration |
| UKECA | United Kingdom Ethics Committee Authority |
| Unexpected Adverse Reaction | An adverse reaction the nature and severity of which is not consistent with the information about a medicinal product as set out: * in the case of a product with a marketing authorisation in the summary of product characteristics for that product * in the case of any other investigational medicinal product, in the investigator's brochure (see entry above) relating to the study in question |
| V | |
| W | back to top |
| WMA | World Medical Association |
| X | back to top |
| Xenogeneic cells | Non-human cells |
| Xenotransplantation | The transplantation of tissue and organs between different species, and in particular the transplantation of animal tissue into humans. |
| Y | |
| Z |