ICH Abbreviations - and definitions

Question 1

ADR

Answer 1

Adverse Drug Reaction - a reaction from a treatment/ intervention where there is evidence of direct causal relationship between the reaction and the drug.

Question 2

AE

Answer 2

Adverse event - an untoward event/ reaction that occurred during participation in the trial, whether directly related or not.

Question 3

ALT

Answer 3

Alanine aminotransferase - Use to assess liver damage

Question 4

AST

Answer 4

Asparate aminotransferase - assess muscle and liver damage - when injured they release this

Question 5

b.i.d

Answer 5

twice a day

Question 6

BP

Answer 6

Blood pressure - mm Hg. The top number (systolic) is the pressure of the blood flow when your heart muscle contracts, pumping blood. The bottom number (diastolic) is the pressure measured between heartbeats.

Question 7

BUN

Answer 7

Blood Urea Nitrogen - used to measure kidney function

Question 8

CIOMS

Answer 8

Council for International Organizations of Medical Sciences

Question 9

CK

Answer 9

Creatine Kinase - found in heart, brain, skeletal muscle, and other tissue. Measures muscle damage.

Question 10

DCF

Answer 10

Data Clarification Form

Question 11

ECG

Answer 11

Electrocardiogram - measures heart activity, with each beat, is a wave

Question 12

EKG

Answer 12

Electrocardiogram - measures heart activity, with each beat, is a wave

Question 13

FEV1

Answer 13

Forced Expiratory Volume in 1 Second, also known as pulmonary function test, how much air you can force out of your lungs in 1 second - using spirometry

Question 14

GCP
GLP
GMP

Answer 14

• good clinical practices
• good laboratory practices
• good manufacturing practices

Question 15

hCG

Answer 15

human chorionic gonadotropin - tested in urine for pregnancy or birth defects, uterine/ testicle cancer

Question 16

HMO

Answer 16

Health Maintenance Organization

Question 17

ICH

Answer 17

International Conference Harmonization

Question 18

LAR

Answer 18

Legally Acceptable Representative

Question 19

MOA

Answer 19

Monoamine Oxidase - detects deficiency, mostly males. mild intellectual disability and behavioral problems beginning in early childhood - Autism/ ADHD

Question 20

PK

Answer 20

Pharmacokinetics - refers to the movement of drug into, through, and out of the body—the time course of its absorption, bioavailability, distribution, metabolism, and excretion.

Question 21

p.r.n

Answer 21

as needed

Question 22

QA /QC

Answer 22

Quality Assurance / Quality Control

Question 23

q.d.

Answer 23

once a day

Question 24

QTc

Answer 24

ECG/EKG QT interval corrected for heart rate - representing ventricular depolarization. Women longer than men, lower heart rates longer - hemorrhage

Question 25

SMO

Answer 25

Site Management Organization

Question 26

t.i.d

Answer 26

three times a day

Question 27

SUSAR

Answer 27

Suspected Unexpected Serious Adverse Reaction - untoward and unintended response to a study drug, which is not listed is the applicable product information, and meets one of the following serious criteria: death, life threatening, prolonged hospitalization, persistent disability, congenital anomaly or birth defect

Question 28

t.i.d

Answer 28

three times a day