Glossary

Question 1

GCP

Answer 1

Good Clinical Practice

Question 2

ICH

Answer 2

International Council for Harmonisation (of Technical Requirements for Pharmaceuticals for Human Use)

Question 3

IRB

Answer 3

Institutional Review Board

Question 4

ICH-GCP (Definition)

Answer 4

Guidelines for GCP defined by the ICH that governments can transpose into regulations for clinical trials involving humans.

Question 5

IEC

Answer 5

Independent Ethics Committee

Question 6

ILT

Answer 6

Investigator Lead Trial (A study initiated by an investigator from academia.)

Question 7

MRA

Answer 7

Medicine Regularity Authorities

Question 8

FDA

Answer 8

Food and Drug Administration (MRA for USA)

Question 9

EMEA

Answer 9

European Medicine Evaluation Agency (MRA for EU)

Question 10

CRO

Answer 10

Contracted Research Organization

Question 11

CRA

Answer 11

Clinical Research Association

Question 12

PI

Answer 12

Principal Investigator

Question 13

CRF

Answer 13

Case Report Form

Question 14

HREC

Answer 14

Human Research Ethics Committee

Question 15

MTD

Answer 15

Maximum Tolerated Dose

Question 16

Pharmacodynamic (Definition)

Answer 16

is the study of the biochemical and physiologic effects of drugs.

Question 17

Pharmacokinetic (Definition)

Answer 17

is a branch of pharmacology dedicated to determine the fate of substances administered to a living organism

Question 18

Immunogenicity (Definition)

Answer 18

is the ability of a foreign substance to provoke an immune response in the body

Question 19

Pivotal Trials (Definition)

Answer 19

a trial that is intended to provide evidence for a drug-marketing approval

Question 20

OSHA

Answer 20

Occupational Safety and Health Act

Question 21

CTA

Answer 21

Clinical Trial Application

Question 22

IND

Answer 22

Investigational New Drug

Question 23

FWA

Answer 23

Federal Wide Assurance

Question 24

CDER

Answer 24

Center for Drug Evaluation and Research (USA)

Question 25

OHRP

Answer 25

Office for Human Research Protection (USA) (a division of the DHHS)

Question 26

DHHS

Answer 26

Departement of Health and Human Services (USA)

Question 27

NIH

Answer 27

National Institute of Health (USA)

Question 28

NCT - Number

Answer 28

National Clinical Trial Number (USA)

Question 29

EudraCT Number

Answer 29

Trial Identification Nunmber (EU)

Question 30

IMPD

Answer 30

Investigational Medicinal Product Dossier (EU)

Question 31

CESP

Answer 31

Common European Submission Portal (EU) -- Acts as a single entry point to faciliate the application and assessment of clinical data between the sponsor, the member state, the regulatory bodies and the general public.