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.

Glossary of terms used in Medical Information


MIMedical Information
HCPHealthcare Professional
DiagnosisThe identification of a disease or condition.
SymptomsThe physical or mental signs that indicate a disease or condition.
TreatmentThe medical intervention used to manage or cure a disease or condition.
PrognosisThe predicted outcome of a disease or condition.
PrescriptionA written order for a medication or treatment.
DoseThe amount of medication or treatment to be administered.
Side EffectAn unintended or adverse reaction to a medication or treatment.
Medical historyA record of a patient’s previous health conditions, treatments, and surgeries.
Off label useUnapproved 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.
IndicationA medical condition that a medicine is used for. This can include the treatment, prevention, and diagnosis of a disease.
Marketing Authorisation Holder MAHThe company or other legal entity that has the authorisation to market a medicine.
FAQFrequently Asked Questions.
SRLStandard response letter; a standardised response for enquirers.
Pregnancy ExposureWhen a woman takes medication during pregnancy, this can cause untoward events.
CardiovascularRelating to the heart and blood vessels.
NeurologicalRelating to the nervous system, including the brain and spinal cord.
GastrointestinalRelating to the digestive system, including the stomach, intestines, and liver.
RespiratoryRelating to the lungs and breathing.

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]