Glossary Flashcards
GCP
Good Clinical Practice
ICH
International Council for Harmonisation (of Technical Requirements for Pharmaceuticals for Human Use)
IRB
Institutional Review Board
ICH-GCP (Definition)
Guidelines for GCP defined by the ICH that governments can transpose into regulations for clinical trials involving humans.
IEC
Independent Ethics Committee
ILT
Investigator Lead Trial (A study initiated by an investigator from academia.)
MRA
Medicine Regularity Authorities
FDA
Food and Drug Administration (MRA for USA)
EMEA
European Medicine Evaluation Agency (MRA for EU)
CRO
Contracted Research Organization
CRA
Clinical Research Association
PI
Principal Investigator
CRF
Case Report Form
HREC
Human Research Ethics Committee
MTD
Maximum Tolerated Dose
Pharmacodynamic (Definition)
is the study of the biochemical and physiologic effects of drugs.
Pharmacokinetic (Definition)
is a branch of pharmacology dedicated to determine the fate of substances administered to a living organism
Immunogenicity (Definition)
is the ability of a foreign substance to provoke an immune response in the body
Pivotal Trials (Definition)
a trial that is intended to provide evidence for a drug-marketing approval
OSHA
Occupational Safety and Health Act
CTA
Clinical Trial Application
IND
Investigational New Drug
FWA
Federal Wide Assurance
CDER
Center for Drug Evaluation and Research (USA)
OHRP
Office for Human Research Protection (USA) (a division of the DHHS)
DHHS
Departement of Health and Human Services (USA)
NIH
National Institute of Health (USA)
NCT - Number
National Clinical Trial Number (USA)
EudraCT Number
Trial Identification Nunmber (EU)
IMPD
Investigational Medicinal Product Dossier (EU)
CESP
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.
