Page 23 - Terminology-Clinical-Research

such bodies are shown below. through the evaluation and supervision of medicines for
human and veterinary use.
• CCI: Committee on Clinical Investigations
EV Product Code: Marketed Product’s EudraVigilance
• CCPPRB: Comité Consultative pour la Protection Number.
des Personnes dans les Recherches Biomédicales
(France) EV Substance Code: Active Substance’s EudraVigilance
Substance Code.
• CHR: Committee on Human Research
Evaluable (for efficacy and safety): Pertains to data or
• CPHS: Committee for the Protection of Human subjects that meet Statistical Analysis Plan criteria for
Subjects inclusion in Efficacy/Safety datasets.

• CRB: Central Review Board Event free survival: Duration from the start of treatment
to a pre-defined ‘event’, which may include specific
• EAB: Ethical Advisory Board
complications of the disease or treatment.
• EC: Ethics Committee
Exchange: The exchange of knowledge refers to the
• HEX: Human Experimentation Committee interaction between the knowledge user and the researcher,
resulting in mutual learning. According to the Canadian
• HSRC: Human Subjects Review Committee Health Services Research Foundation (CHSRF), the
definition of knowledge exchange is “collaborative
• IEC: Independent Ethics Committee problem-solving between researchers and decision makers
that happens through linkage and exchange. Effective
• IRB: Independent Review Board; Institutional knowledge exchange involves interaction between
Review Board
knowledge users and researchers and results in mutual
• LREC: Local Research Ethics Committees (UK) learning through the process of planning, producing,
disseminating, and applying existing or new research in
• MREC: Multicentre Research Ethics Committees decision making.”
(UK)
Exclusion/inclusion criteria: The medical or social
• NIRB: Noninstitutional Review Board standards determining whether a person may or may not
be allowed to enter a clinical trial. These criteria are based
• NRB: Noninstitutional Review Board, also known on such factors as age, gender, pregnancy status, the type
as an Independent Review Board and stage of a disease, previous treatment history, and other
medical conditions. It is important to note that inclusion and
• REB: Research Ethics Board (Canada)
exclusion criteria are not used to reject people personally,
Ethnicity: Denotes social groups with a shared history, but rather to identify appropriate participants to ensure the
sense of identity, geography, and cultural roots. integrity of the study and to keep them safe.

EU: European Union. Excretion: The act or process of eliminating waste
products from the body.
EudraCT: EudraCT (European Union Drug Regulating
Authorities Clinical Trials) is the European Clinical Trials Expanded access: A process regulated by the Food and
Database of all interventional clinical trials of medicinal Drug Administration (FDA) that allows manufacturers to
products commencing in the European Union from 1 May provide investigational new drugs to patients with serious
2004 onwards. The EudraCT database has been established diseases or conditions who cannot participate in a clinical
in accordance with Directive 2001/20/EC. trial. One of several study types.

European Medicines Agency (EMEA): The European Experimental arm: A group of participants that receives
regulatory agency responsible for the scientific evaluation the intervention that is the focus of the study. One of several
of applications for European marketing authorization for arm types.
medicinal products (centralized procedure). EMEA’s main Experimental drug: A drug that is not FDA licensed for
mission is to protect and promote public and animal health,

TERMINOLOGY CLINICAL RESEARCH 23