Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
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Glossary of Terms and Abbreviations<br />
AE Adverse Event<br />
AR Adverse Reaction<br />
ASR Annual Safety Report<br />
CA Competent Authority<br />
CI Chief Investigator<br />
CRF Case Report Form<br />
CRO Contract Research Organisation<br />
CTA Cl<strong>in</strong>ical Trial Authorisation<br />
CTIMP Cl<strong>in</strong>ical Trial of Investigational Medic<strong>in</strong>al Product<br />
CTPU Cancer Prevention Trial Unit<br />
DMARD Disease Modify<strong>in</strong>g Anti-Rheumatic Drug<br />
DMC Data Monitor<strong>in</strong>g Committee<br />
EC European Commission<br />
<strong>EME</strong>A European Medic<strong>in</strong>es Agency<br />
EU European Union<br />
EUCTD European Cl<strong>in</strong>ical Trials Directive<br />
EudraCT European Union Drug Regulat<strong>in</strong>g Authorities Cl<strong>in</strong>ical Trials<br />
EudraVIGILANCE European Union Drug Regulat<strong>in</strong>g Authorities Pharmacovigilance<br />
GAfREC Governance Arrangements for NHS Research Ethics Committees<br />
GCP Good Cl<strong>in</strong>ical Practice<br />
GMP Good Manufactur<strong>in</strong>g Practice<br />
IB Investigator Brochure<br />
ICF Informed Consent Form<br />
IMP Investigational Medic<strong>in</strong>al Product<br />
IMPD Investigational Medic<strong>in</strong>al Product Dossier<br />
ISRCTN International Standard <strong>Randomised</strong> Controlled Trial Number<br />
JRMO Jo<strong>in</strong>t Research and Management Office<br />
MA Market<strong>in</strong>g Authorisation<br />
MHRA Medic<strong>in</strong>es and Healthcare products Regulatory Agency<br />
MS Member State<br />
Ma<strong>in</strong> REC Ma<strong>in</strong> Research Ethics Committee<br />
NHS R&D National Health Service Research & Development<br />
PI Pr<strong>in</strong>ciple Investigator<br />
QA Quality Assurance<br />
QC Quality Control<br />
QP Qualified Person for release of trial drug<br />
Participant An <strong>in</strong>dividual who takes part <strong>in</strong> a cl<strong>in</strong>ical trial<br />
RCT <strong>Randomised</strong> Controlled Trial<br />
REC Research Ethics Committee<br />
SAE Serious Adverse Event<br />
SAR Serious Adverse Reaction<br />
SDV Source Document Verification<br />
SmPC Summary of Product Characteristics<br />
SOP Standard Operat<strong>in</strong>g Procedure<br />
SSA Site Specific Assessment<br />
SUSAR Suspected Unexpected Serious Adverse Reaction<br />
TMG Trial Management Group<br />
TSC Trial Steer<strong>in</strong>g Committee<br />
US Ultrasound<br />
Study: R4RA EudraCT: 2012-002535-28 8 / 34