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
AE See adverse event
Blinding The 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.
CI Chief 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 Trial Any 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.
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.
CTI Clinical Trial Investigator – see Investigator
 Concomitant medication A list of drugs in the study protocol that are prohibited or allowed to be taken by the study subject during the study period.
Control Group A 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.
Double-Blind The design of a study in which neither the investigator nor the subject knows which medication (or placebo) the subject is receiving.
Eligibility criteria Summary criteria for participant selection; includes Inclusion and Exclusion criteria.
Exclusion criteria Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
Health Care Professional A doctor, dentist, nurse, pharmacist or registered ophthalmic optician or other officially registered health professional.
IB see Investigator’s brochure
IMP Investigational medicinal product
Inclusion Criteria A list of criteria that must be met by all study subjects.
Investigator A 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 trial see Open-Label Study.
Open-Label Study A 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 card  A 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 or subject number The unique identifier for an individual subject. The subject number may be long and also include the site number.
Phase of a trial The 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.

Placebo An 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.
Protocol See Study protocol.
Randomisation Study 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 trial A trial where subjects are randomly allocated to a treatment group or to a control group (who do not receive the drug under investigation).
SAE see 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 number Name or identification number of a hospital, health centre, surgery or other establishment or facility from which a trial is conducted.
Sponsor The 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 Name This 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 Protocol A document that describes the objective(s), design and organisation of a trial.
Subject number See Patient number.
Summary of Product Characteristics (SPC) 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 subject An 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.
Unblinding This 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

Letter Code Word Recommended Transcription Phonetic Notation
A Alpha AL-fah [ˈælfɑː]
B Bravo BRAH-voh [ˈbrɑːvoʊ]
C Charlie CHAR-lee or SHAR-lee [ˈtʃɑrliː] or[ˈʃɑrliː]
D Delta DEL-tah [ˈdɛltɑː]
E Echo EK-oh [ˈɛkoʊ]
F Foxtrot FOKS-trot [ˈfɒkstrɒt]
G Golf GOLF [ˈɡɒlf]
H Hotel hoh-TEL [hoʊˈtɛl]
I India IN-dee-ah [ˈɪndiːɑː]
J Juliet JEW-lee-et or JEW-lee-ET [ˈdʒuːliːɛt] or [ˌdʒuːliːˈɛt]
K Kilo KEE-loh [ˈkiːloʊ]
L Lima LEE-mah [ˈliːmɑː]
M Mike MYK [ˈmaɪk]
N November noh-VEM-bər [noʊˈvɛmbər]
O Oscar OS-kah [ˈɒskɑː]
P Papa pah-PAH [pɑːˈpɑː]
Q Quebec ke-BEK [kɛˈbɛk]
R Romeo ROH-mee-oh [ˈroʊmiːoʊ]
S Sierra see-ERR-ah [siːˈɛrɑː]
T Tango TANG-goh [ˈtæŋɡoʊ]
U Uniform EW-nee-form or OO-nee-form [ˈjuːniːfɔrm] or [ˈuːniːfɔrm]
V Victor VIK-tah [ˈvɪktɑː]
W Whiskey WIS-kee [ˈwɪskiː]
X X-ray EKS-ray or EKS-RAY [ˈɛksreɪ] or [ˌɛksˈreɪ]
Y Yankee YANG-kee [ˈjæŋkiː]
Z Zulu ZOO-loo [ˈzuːluː]