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] |