Glossary of terms used in clinical trials

Adverse event (AE)Any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
AESee adverse event
BlindingThe process through which one or more parties to a clinical trial are unaware of the treatment assignments.  In a single-blinded study, usually the subjects are unaware of the treatment assignments.  In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. “Blinded” studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known.
CIChief investigator, the person who takes overall responsibility for the design, conduct and reporting of a study.
Clinical Research Associate (CRA)Person employed by the study sponsor or CRO to monitor a clinical study at all participating sites.
Clinical TrialAny investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent’s safety and efficacy.
Clinical Trial Protocol (CTP)See Study Protocol
Concomitant medicationA list of drugs in the study protocol that are prohibited or allowed to be taken by the study subject during the study period.
Contract Research Organisation (CRO)An organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may conduct a clinical trial on behalf of the Sponsor.
Control GroupA comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
CTIClinical Trial Investigator – see Investigator
Double-BlindThe design of a study in which neither the investigator nor the subject knows which medication (or placebo) the subject is receiving.
Eligibility criteriaSummary criteria for participant selection; includes Inclusion and Exclusion criteria.
Exclusion criteriaRefers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
Health Care ProfessionalA doctor, dentist, nurse, pharmacist or registered ophthalmic optician or other officially registered health professional.
IBsee Investigator’s brochure
IMPInvestigational medicinal product
Inclusion CriteriaA list of criteria that must be met by all study subjects.
Informed Consent Form (ICF)A document that requires a participant’s signature upon participating in a clinical trial, to confirm that the patient consents to participate and has been informed of the nature, significance, implications and risks of the trial (see Patient Information Sheet)
InvestigatorA medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.
Investigator’s brochure (IB)A compilation of the clinical and non-clinical data on the investigational product(s) which is relevant to the study of the product(s) in humans.
Open trialsee Open-Label Study.
Open-Label StudyA study in which all parties, (patient, physician and study coordinator) are informed of the drug and dose being administered. In an open-label study, none of the participants are given placebos.
Patient cardA card, supplied to the trial subject by the Sponsor providing information required in an emergency situation, for example; the trial number, trial title, product name/number, Sponsor name/address/telephone number and emergency contact details for Investigator.
Patient Information Sheet (PIS)A document provided to the trial subject to inform them of nature, significance, implications and risks of the trial in order for them to provide informed consent (see Informed Consent Form).
Patient or subject numberThe unique identifier for an individual subject. The subject number may be long and also include the site number.
Phase of a trialThe phases of a clinical trial can generally be categorized in the following terms:
·         Phase I – Human pharmacology
·         Phase II – Therapeutic exploratory
·         Phase III – Therapeutic confirmatory
·         Phase IV – Therapeutic use
PlaceboAn inactive substance designed to resemble the drug being tested.  It is used as a control to rule out any psychological effects testing may present.  Most well-designed studies include a control group which is unwittingly taking a placebo.
Principal Investigator (PI)The authorised health professional responsible for the conduct of that trial at a trial site.
ProtocolSee Study protocol.
RandomisationStudy participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.
Randomised controlled trialA trial where subjects are randomly allocated to a treatment group or to a control group (who do not receive the drug under investigation).
SAEsee Serious Adverse Event.
Serious Adverse Event (SAE)Any untoward medical occurrence in a subject to whom a medicinal product has been administered that results in death or is life threatening or requires hospitalisation or prolongation of existing hospitalisation or results in persistent or significant disability or incapacity or is a congenital anomaly or birth defect including occurrences which are not necessarily caused by or related to that product.
Site name or numberName or identification number of a hospital, health centre, surgery or other establishment or facility from which a trial is conducted.
SponsorThe individual or organisation that takes on responsibility for confirming that there are proper arrangements in place to initiate, manage and monitor, and finance a study. Responsibilities are defined by the Research Governance Frameworks and by the Clinical Trials Regulations.
Study NameThis is a combination of letters and/or numbers that uniquely identifies the study.  Study titles are often shortened to one or two words for ease of use e.g. the PATTERN study, the ADIOS study.
Study ProtocolA document that describes the objective(s), design and organisation of a trial.
Subject numberSee Patient number.
Summary of Product Characteristics (SPC/SmPC)The basis of information for health professionals on how to use the medicinal product safely and effectively. They are written and updated by pharmaceutical companies and are based on their research and product knowledge. It is then checked and approved by the UK or European medicines licensing agency.
Trial subjectAn individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.  Also referred to as the patient.
UnblindingThis involves revealing the treatment allocation of a particular subject.  This usually occurs at the end of a trial but may occur due to other circumstance e.g. in an emergency situation.  A subject that has been unblinded before the end of a trial will be removed from the trial and all their data will not be used in the subsequent analysis.

NATO phonetic alphabet

LetterCode WordRecommended TranscriptionPhonetic Notation
CCharlieCHAR-lee or SHAR-lee[ˈtʃɑrliː] or[ˈʃɑrliː]
JJulietJEW-lee-et or JEW-lee-ET[ˈdʒuːliːɛt] or [ˌdʒuːliːˈɛt]
UUniformEW-nee-form or OO-nee-form[ˈjuːniːfɔrm] or [ˈuːniːfɔrm]
XX-rayEKS-ray or EKS-RAY[ˈɛksreɪ] or [ˌɛksˈreɪ]