Glossary

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.
Clinical Trial Protocol (CTP)	See Study Protocol
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.
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 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.
CTI	Clinical Trial Investigator – see Investigator
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.
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)
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.

Glossary of terms used in Medical Information

MI	Medical Information
HCP	Healthcare Professional
Diagnosis	The identification of a disease or condition.
Symptoms	The physical or mental signs that indicate a disease or condition.
Treatment	The medical intervention used to manage or cure a disease or condition.
Prognosis	The predicted outcome of a disease or condition.
Prescription	A written order for a medication or treatment.
Dose	The amount of medication or treatment to be administered.
Side Effect	An unintended or adverse reaction to a medication or treatment.
Medical history	A record of a patient’s previous health conditions, treatments, and surgeries.
Off label use	Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat.
Indication	A medical condition that a medicine is used for. This can include the treatment, prevention, and diagnosis of a disease.
Marketing Authorisation Holder MAH	The company or other legal entity that has the authorisation to market a medicine.
FAQ	Frequently Asked Questions.
SRL	Standard response letter; a standardised response for enquirers.
Pregnancy Exposure	When a woman takes medication during pregnancy, this can cause untoward events.
Cardiovascular	Relating to the heart and blood vessels.
Neurological	Relating to the nervous system, including the brain and spinal cord.
Gastrointestinal	Relating to the digestive system, including the stomach, intestines, and liver.
Respiratory	Relating to the lungs and breathing.

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]