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Guide to Clinical Trials (Shamley, Wright) > Glossary > Flashcards

Glossary Flashcards

1
Q

GCP

A

Good Clinical Practice

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2
Q

ICH

A

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

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3
Q

IRB

A

Institutional Review Board

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4
Q

ICH-GCP (Definition)

A

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

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5
Q

IEC

A

Independent Ethics Committee

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6
Q

ILT

A

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

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7
Q

MRA

A

Medicine Regularity Authorities

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8
Q

FDA

A

Food and Drug Administration (MRA for USA)

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9
Q

EMEA

A

European Medicine Evaluation Agency (MRA for EU)

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10
Q

CRO

A

Contracted Research Organization

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11
Q

CRA

A

Clinical Research Association

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12
Q

PI

A

Principal Investigator

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13
Q

CRF

A

Case Report Form

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14
Q

HREC

A

Human Research Ethics Committee

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15
Q

MTD

A

Maximum Tolerated Dose

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16
Q

Pharmacodynamic (Definition)

A

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

17
Q

Pharmacokinetic (Definition)

A

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

18
Q

Immunogenicity (Definition)

A

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

19
Q

Pivotal Trials (Definition)

A

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

20
Q

OSHA

A

Occupational Safety and Health Act

21
Q

CTA

A

Clinical Trial Application

22
Q

IND

A

Investigational New Drug

23
Q

FWA

A

Federal Wide Assurance

24
Q

CDER

A

Center for Drug Evaluation and Research (USA)

25
Q

OHRP

A

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

26
Q

DHHS

A

Departement of Health and Human Services (USA)

27
Q

NIH

A

National Institute of Health (USA)

28
Q

NCT - Number

A

National Clinical Trial Number (USA)

29
Q

EudraCT Number

A

Trial Identification Nunmber (EU)

30
Q

IMPD

A

Investigational Medicinal Product Dossier (EU)

31
Q

CESP

A

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.

Guide to Clinical Trials (Shamley, Wright) (5 decks)

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