ABPI Guidelines for Phase 1 Clinical Trials (PDF

Radioactive isotope - an unstable form of an element that breaks up into other elements and in so doing gives out radiation
that can be measured.
Radiolabel - technique of incorporating a radioactive isotope into a molecule.
Radiopharmaceutical product - a product that includes a radioactive isotope.
Randomisation - the process of allocating trial subjects to IMP (active, placebo or comparator) by chance, so as to
reduce bias.
Receptor - a structure on the surface of a cell (or inside the cell) that selectively receives and binds a specific substance.
Regulatory (competent) authorities - bodies such as the MHRA that review submitted clinical data and conduct
inspections.
Reproductive toxicology - a series of toxicity tests in animals to assess the risk of giving an IMP to a fertile woman or man,
or a woman who is pregnant.
Research ethics committee (REC) - an independent group of medical and scientific professionals and members of the
public, with no financial interests or affiliations with the sponsor or researchers, who give an opinion on the ethics of a
trial.
Rescue medication - treatment given to a subject to relieve a problem brought about by taking part in a clinical trial.
Resuscitation Council (UK) - provides education and reference materials to healthcare professionals and the general public
in the most effective methods of resuscitation.
Risk - potential for harm.
Scintillation counter - a machine for measuring radiation, that counts light flashes emitted from a detector substance
exposed to radiation.
Serious adverse event (SAE) or serious adverse drug reaction (serious ADR) - any untoward medical event that at any dose
of a medicinal product:
• results in death;
• is life-threatening;
• requires a stay in hospital or prolongs an existing stay in hospital;
• results in persistent or significant disability or incapacity; or
• is a congenital anomaly or birth defect.
Shipping (dispatch) - packing and sending trial-related material somewhere.
Sievert - a unit of radiation exposure. The average person in the UK receives about 2.5 milliSievert of 'background'
radiation annually from the environment. A chest X-ray represents about 10 days of 'background' radiation.
Signature - a distinct record (initials, or full handwritten or electronic signature) of the person who was responsible for a
particular action or review.
Single photon emission computed tomography (SPECT) - similar to positron emission tomography, but uses an isotope with
a longer half-life (hours rather than minutes) that does not have to be made by a cyclotron machine.
Single photon emitters - radioactive isotopes that mainly emit gamma or X-rays.
Small molecules - see new chemical entities.
Somatic cells - cells other than egg or sperm cells.
Source data - all information in original records, and certified copies of original records, of clinical findings, observations,
or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are found in
source documents.
Source documents - original or certified copies of documents, data and records such as charts, laboratory notes,
memoranda, diaries, checklists, dispensing records, printed output from instruments, and records kept at the pharmacy,
laboratories and other departments involved in the trial.
Sponsor - an individual, company, institution or organisation that is responsible for the initiation, management and/or
financing of a clinical trial.
Standard operating procedure (SOP) - detailed, written instructions to ensure that trial-related procedures are done in the
approved way by everybody.
Statutory instrument (SI) - a power delegated by Parliament. Parliament can delegate its power to make and amend law to
a person or organisation. A statutory instrument is one of these powers and is used by government ministers to amend
legislation.
Sterility - the absence of living organisms.
© Association of the British Pharmaceutical Industry 2007
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