| ABPI |
Association of British Pharmaceutical Industries |
| AE |
Adverse Event |
| AR |
Adverse Reaction |
| AFSSaPs |
French Medicines Agency |
| BAPM |
British Association of Perinatal Medicine |
| BPA |
British Paediatric Association (now RCPCH) |
| CHaRT |
Centre for Healthcare Randomised Trials |
| CMSHE |
Centre of Medical Statistics & Health Evaluation |
| CRG |
Collaborative review Group |
| CSG |
Clinical Studies Group |
| CSM |
Committee on Safety of Medicines (Now CHM) |
| CHM |
Commission on Human Medicines (from Nov 2005) |
| COREC |
Central Office for Research Ethics Committees |
| CREDO |
Commercialisation, Research & European Development Office |
| CRF |
Clinical Research Facility |
| CRF |
Case Report Form |
| CSG |
Clinical Studies Group (MCRN) |
| CSO |
Chief Scientist Office |
| CTA |
Clinical Trials Authorisation |
| CTIMP |
Clinical Trial in an Investigational Medicinal Product |
| CTU |
Clinical Trials Unit |
| DEC-net |
Drug Evaluation in Children register |
| DFID |
Department for International Development |
| DH/DOH |
Department of Health (England) |
| EDCTP |
European & Developing Countries Clinical Trial Partnership |
| ELSI |
Ethical, legal & social issues |
| EMEA |
European Medicines Evaluation Agency |
| ENDIC |
European Network for Drug Investigation in Children |
| EPA |
European Practice Assessment |
| ESDP |
European Society for Developmental, perinatal & paediatric pharmacology |
| EudraCT |
European clinical trials database |
| FDA |
Food & Drug Agency (US) |
| FDMA |
Food and Drug Administration Modernization Act |
| GCP |
Good Clinical Practice |
| GMP |
Good Manufacturing Practice |
| GPRF |
General Practice research Framework |
| GPRD |
General Practice Research Database |
| HTA |
Health Technology Assessment |
| ICH |
International Conference on Harmonisation |
| IMPs |
Investigational Medicinal Products |
| IRB |
Institutional Review Board |
| ISRCTN |
International Standard Randomised Controlled Trial Number Register |
| LREC |
Local Research Ethics Committee |
| MCRN |
Medicines for Children Research Network |
| MCRNCC |
Medicines for Children Research Network Coordinating Centre |
| MEMO |
Medicines Monitoring Group |
| MHRA |
Medicines and Healthcare Products Regulatory Agency |
| MREC |
Multi-Centre Research ethics Committee |
| MRC |
Medical Research Council |
| NCB |
National Children's Bureau |
| NCRN |
National Cancer Research Network |
| NCRNCC |
National Cancer Research Network Coordinating Centre |
| NICE |
National Institute for Clinical Excellence |
| ONS CR |
Office of National Statistics Central Register |
| OMG |
Operational Management Group |
| PA |
Programmed Activity |
| PCT |
Patient Care Trust |
| PDT |
Product Development Team |
| PI |
Principle Investigator |
| PIP |
Paediatric Investigation Plan |
| PIL |
Patient Information Leaflet |
| PK/PD |
Pharmaco-Kinetics/Pharmaco-Dynamics |
| PUMA |
Paediatric Use Marketing Authorisation |
| QALY |
Quality-adjusted Life Years |
| RAE |
Research Assessment Exercise |
| RCPCH |
Royal College of Paediatrics and Child Health |
| RCT |
Randomised Control Trial |
| R&D |
Research & Development |
| RDSU |
R&D Support Unit |
| REC |
Research Ethics Committee |
| RST |
Research Support Team |
| SAE |
Serious Adverse Event |
| SDRN |
Scottish Diabetic Research Network |
| SHA |
Strategic Health Authority |
| SHIL |
Scottish Health Innovations Ltd |
| SPC |
Supplementary Patent Certificate |
| SMC |
Scottish Medicines Consortium |
| SMCN |
Scottish Medicines for Children's Network |
| SmPC/SPC |
Summary of Product Characteristics |
| SOP |
Standard Operating Procedure |
| SPICEpc |
Scottish Programme for Improving Clinical Effectiveness in Primary Care |
| SSAR |
Suspected Serious Adverse Reaction |
| SUSAR |
Suspected Unexpected Serious Adverse Reaction |
| UKCRC |
UK Clinical Research Collaboration |
| UKCRN |
UK Clinical Research Network |
| UKCRNCC |
UK Clinical Research Network Coordinating Centre |
| UKMI |
UK Medicines Information Network |
| VOTES |
Virtual Organisation of Trials & Epidemiological Studies |