Incapacitated AdultAn adult unable by virtue of physical or mental incapacity to give informed consent.
Inclusion CriteriaSpecific criteria which are defined within the study protocol that expressly include specific individuals to participate in a study e.g. individuals within a certain age range, with a specific condition, etc.
IndemnityInsurance or indemnity includes provision for meeting losses or liabilities— a) under a scheme established under— i) section 21 of the National Health Service and Community Care Act 1990 (schemes for meeting losses and liabilities etc. of certain health service bodies in England and Wales)(d), ii) section 85B of the National Health Service (Scotland) Act 1978 (schemes for meeting losses and liabilities etc. of certain health service bodies in Scotland)(e), or iii) Article 24 of the Health and Personal Social Services (Northern Ireland) Order 1991(schemes for meeting losses and liabilities etc. of certain health service bodies in Northern Ireland)(f), or b) in accordance with guidance issued by— i) the Secretary of State, ii) the Scottish Ministers, iii) the National Assembly for Wales, or iv) the Department for Health, Social Services and Public Safety, As to the arrangements to be adopted by health service bodies for meeting the costs arising from clinical negligence (known as NHS Indemnity).
Informed Consent (IC)A process by which a subject voluntarily confirms his or 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. For CTIMPs: A person gives informed consent to take part only if his/her decision: a) is given freely after that person is informed of the nature, significance, implications and risks of the trial; and b) either— i) is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or ii) if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.
InspectionThe act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and / or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect. In the UK, the MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA.
Institutional Review Board (IRB)The generic term used by the Food & Drugs Administration (FDA) in the United States for independent ethics committees that have been formally designated to review and monitor biomedical research involving human subjects.
Integrated Research Application System (IRAS)The online application system used to apply for most permissions and approvals for research in health and social care in the UK.
Intellectual Property (IP)IP can be described as the novel or previously undescribed tangible output of any intellectual activity. It has an owner and can be bought, sold or licensed and must be adequately protected. It can include inventions, industrial processes, software, data, written works, designs and images.
Interactive Response Technologies (IRTs)
Interactive Response Technology (IRT) is software that enables activities such as randomisation into clinical trial and dispensing medications in a blinded trial. Examples include telephone based Interactive Voice Response Systems (IVRS) or internet based, Interactive Web Response Systems (IWRS). These technologies are also used in other trial management activities and the EMA has published a reflection paper with further guidance. View the Reflection Paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials pdf.
Interim AnalysisAn analysis comparing intervention groups undertaken at any time before the formal completion of the trial, usually before recruitment is complete. Often used with "stopping rules" so that a trial can be stopped if participants are being put at risk unnecessarily. Timing and frequency of interim analyses should be specified in the protocol.
Internal AgreementsAn agreement between an organisation and relevant internal parties. Examples include: Agreements, memoranda or documentation between a ' R&D Office' and clinical and non-clinical support services in order to facilitate engagement and internal authorisation from named support service leads. Agreements between a Principal Investigator / Chief Investigator and support service or stakeholders within an organisation. Agreements between the organisation and relevant party for resources who require an honorary research contract or letter of access. These agreements may be in the form of a standardised document or email format.
International Committee of Medical Journal Editors (ICMJE)The ICMJE is a group of general medical journal editors whose participants meet annually and fund their work on the Uniform Requirements for Manuscripts.
International Conference on Harmonisation (ICH)International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs to establish common standards for clinical trials.
International Standard Randomised Controlled Trial Number (ISRCTN)A simple numeric system for the unique identification of randomised controlled trials worldwide. The randomly generated number is unique to a registered trial, thereby ensuring that the trial can be simply and unambiguously tracked throughout its lifecycle. The ISRCTN Register also accepts registration of other forms of studies designed to assess the efficacy of health-care interventions.
InterventionA process or action that is the focus of a clinical study. This can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include non-invasive approaches such as surveys, education, and interviews.
Interventional TrialA clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
Investigational Medicinal Product (IMP)A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a Clinical Trial, and includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial - a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorisation, b) used for an indication not included in the summary of product characteristics under the authorisation for that product, or c) used to gain further information about the form of that product as authorised under the authorisation.
Investigational Medicinal Product Dossier (IMPD)The IMPD includes summaries of information related to the quality, manufacture and control of any IMP (including reference product and placebo), and data from non-clinical and clinical studies.
Investigator Site File (ISF)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.
Investigator’s Brochure (IB)
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. Guidance on when an Investigator's Brochure is required can be accessed from the Trial Supplies station.