| ABPI |
Association Of The British Pharmaceutical Industry |
| ACDP |
Advisory Committee on Dangerous Pathogens |
| ACDM |
Association Of Clinical Data Managers |
| ADE |
Adverse Drug Event; Adverse Drug Effect |
| ADME |
Absorption, Distribution, Metabolism And Excretion |
| ADR |
Adverse Drug Reaction |
| AE |
Adverse Event |
| ALT |
Alanine Aminotransferase |
| AMG |
Arzneimittelgesetz (German Drug Law) |
| ANC |
Absolute Neutrophil Count |
| APD |
Action Potential Duration |
| AST |
Aspartate Aminotransferase |
| AUC |
Area Under the Curve |
| b.d. |
Bis In Diem / Twice A Day |
| BARQA |
British Association Of Research Quality Assurance |
| BfArM |
Bundesinstitut Für Arzneimittel Und Medizinprodukte (Germany) |
| BM |
Bone Marrow |
| BMA |
British Medical Association |
| BMD |
Biomarker Development Or Bone Marrow Depression |
| BSA |
Body Surface Area |
| BUN |
Blood Urea Nitrogen |
| CA |
Competent Authority |
| CBC |
Complete Blood Count |
| CDER |
Centre for Drug Evaluation And Research (USA) |
| CEA |
Carcino-Embryonic Antigen |
| CFR |
Code of Federal Regulations (USA) |
| CHF |
Congestive Heart Failure |
| CHMP |
Committee for Medicinal Products For Human Use (EU) |
| CHVP |
Committee for Medicinal Products For Veterinary Use (EU) |
| CI |
Chief Investigator |
| CNS |
Central Nervous System |
| CONSORT |
Consolidated Standards of Reporting Trials |
| COSTART |
Coding Symbols for a Thesaurus of Adverse Reaction Terms |
| CR |
Complete Response |
| CRA |
Clinical Research Associate |
| CRF |
Case Report Form |
| CRO |
Contract Research Organization |
| CRO |
Clinical/Contract Research Organisation |
| CRu |
Unconfirmed Complete Response |
| CRU |
Clinical Research Unit |
| CSF |
Cerebrospinal Fluid |
| CSM |
Committee on Safety Of Medicines (UK) |
| CSR |
Clinical Study Report |
| CT |
Computed Tomography |
| CT |
Clinical Trial |
| CTA |
Clinical Trial Administrator |
| CTA |
Clinical Trial Agreement |
| CTA |
Clinical Trial Authorisation |
| CTIMP |
Clinical Trial of an Investigational Medicinal Product |
| CTR |
Clinical Trial Report |
| DCF |
Data Correction Form / Data Clarification Form |
| DCT |
Data Collection Tool |
| DLT |
Dose-Limiting Toxicity |
| DNA |
Deoxyribonucleic Acid |
| DOB |
Date Of Birth |
| DOH |
Department Of Health (UK) |
| DSMB |
Data Safety Monitoring Board |
| ECG |
Electrocardiogram |
| eCRF |
Electronic Case Record Form |
| EDC |
Electronic Data Capture |
| EDTA |
Edetic Acid (Ethylenediaminetetraacetic Acid) |
| EFGCP |
European Forum For Good Clinical Practice |
| EFPIA |
European Federation Of Pharmaceutical Industries And Associations |
| EGFR |
Epithelial Growth Factor Receptor
|
|
EMA
|
European Medicines Agency |
| EORTC |
European Organisation for Research and Treatment of Cancer |
| EPAR |
European Public Assessment Report |
| EUDRA |
European Union Drug Regulatory Authorities |
| EUDRACT |
The EU Clinical Trials Data Base |
| FDA |
Food And Drug Administration (USA) |
| FPI |
First Patient In |
| FPO |
First Patient Out |
| GAfREC |
Governance Arrangements for Research Ethics Committees (UK) |
| GAMP |
Good Automated Manufacturing Practice |
| GCP |
Good Clinical Practice |
| G-CSF |
Granulocyte Colony-Stimulating Factor |
| GI |
Gastrointestinal |
| GLP |
Good Laboratory Practice |
| GLPMA |
GLP Monitoring Authority |
| GM-CSF |
Granulocyte-Macrophage Colony-Stimulating Factor |
| GMP |
Good Manufacturing Practice |
| GTAC |
Gene Therapy Advisory Committee |
| GVPP |
Good Pharmacovigilance Practice |
| GxP |
An acronym used to refer collectively to Good Laboratory, Manufacturing and Clinical Practices (GLP, GMP and GCP). |
| HbA |
Adult Haemoglobin |
| Hgb or Hb |
Haemoglobin |
| HIPAA |
Health Insurance Portability And Accountability Act (USA) |
| HIV |
Human Immunodeficiency Virus |
Acronyms and Abbreviations A-H