ABPI Guidelines for Phase 1 Clinical Trials (PDF

Appendix 5: Glossary of terms
Accelerator mass spectrometry (AMS) - an extremely sensitive and accurate method of analysing a very small dose -
a microdose - of an IMP labelled with an isotope ( 14 C).
Accreditation - recognition that a trial-related function meets an official quality standard. Examples are accreditation of a
quality system by ISO 9001, a pathology laboratory by a College of Pathology, a phase 1 unit by MHRA, and a REC by
NRES (formerly COREC).
Administration of Radioactive Substances Advisory Committee (ARSAC) - decides if the amount of radioactivity subjects
receive in a clinical trial is within acceptable limits.
Adverse event (AE) - an unwanted clinical symptom, sign or disease, or an abnormal laboratory finding, that is related in
time to, but is not necessarily caused by, the administration of an IMP to a subject in a clinical trial.
Agonist - binds to a cell receptor and triggers a response by the cell. An agonist often mimics the action of a naturally
occurring substance.
Algorithm - procedure for making a series of choices among alternative decisions to reach an outcome.
Anaphylactic reaction - an allergic reaction that is life-threatening.
Antigen - a substance which when introduced into the body stimulates the immune system to make a specific immune
response, such as production of an antibody that binds to the antigen. An antigen may cause an allergic reaction.
Appraisal - a review of a person's performance and development needs.
Association of the British Pharmaceutical Industry (ABPI) - a trade association of pharmaceutical, biotechnology, research
and development, or associated companies with either their main or subsidiary premises in the UK.
Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) - a group of people who are involved in
commercial phase 1 trials and hold twice-yearly symposia to educate members.
Audit - a systematic and independent review of trial-related activities and documents, to find out if the activities were
carried out, and if the data were recorded, analysed, and accurately reported, according to the protocol, SOP, GCP, GMP
and regulatory requirements.
Audit certificate - written evidence that a trial-related function has been audited.
Audit report - an auditor's written report of his or her findings.
Audit trail - documentation of events at each stage of a trial that allows an auditor to trace the source of the data, track
changes, and assess if the data are genuine.
Batch - a defined amount of starting material, packaging material or IMP that is prepared in one process or a series of
processes and is expected to be uniform within specified limits.
Batch release - the process of signing off a batch of IMP by a qualified person (QP).
Bioavailability - a measure of how well a medicine is absorbed by the body.
Bioequivalence - two medicines are bioequivalent if their bioavailability does not differ significantly when they are used in
a trial at the same dose and under similar conditions.
Biological investigational medicinal products - potential new medicines, such as proteins, cytokines, monoclonal
antibodies, genetically-modified micro-organisms and gene therapy, resulting from advances in cell biology and in
biotechnology.
Biomarker - a laboratory or clinical measure of the body's response to an IMP that might indicate that the IMP is working.
When a biomarker can replace a clinical endpoint, it is called a surrogate endpoint.
Biotechnology - the application of the biological sciences, especially genetics, to technological or industrial uses.
BioIndustry Association (BIA) - a trade association for the UK bioscience sector.
Bivalent antibody - antibody with two binding sites.
Blinding - a procedure in which one or more of the parties to a trial do not know which IMP (active, placebo or
comparator) is allocated to which trial subject.
Calibration - demonstrating that an instrument or device gives results within specified limits by comparing them with the
results obtained with a standard over a range of measurements.
Case report form (CRF) - a printed, optical, or electronic document designed to record all of the information that is
required by the clinical trial protocol, and is to be reported to the sponsor, for each trial subject.
Central Office for Research Ethics Committees (COREC) - responsible for coordinating, training and accrediting all UK
research ethics committees. (Name changed to National Research Ethics Service [NRES] in March 2007)
© Association of the British Pharmaceutical Industry 2007
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