Clinical trials with medicinal products (CTR)

Specific rules for the submission, assessment and conduct of clinical trials with medicinal products are set out in the EU Clinical Trial Regulation 536/2014 (CTR). The CTR applies in the European Union as of 31 January 2022.

The Clinical Trials Coordination and Advisory Group (CTAG) of the European Commission published a Quick guide for sponsors and investigators on the CTR and the submission of a clinical trial application: Quick guide on the rules and procedures of the CTR.

List of abbreviations

Abbreviation Explanation
AMS Additional Member State
ATMP Advanced Therapy Medicinal Product. An ATMP is defined as either a gene therapy ‘medicinal product’ (GTMP), a somatic cell therapy ‘medicinal product’ (sCTMP) or a tissue-engineered product (TEP)
AxMP Auxiliary Medicinal Product
CTIS Clinical Trial Information System (EU portal and database)
CTR Clinical Trial Regulation EU No. 536/2014
CCMO Central Committee on Research involving Human Subjects
CCMO_NCTO National Clinical Trial Office - CCMO
cMS Member State Concerned
EEA European Economic Area (European Union plus Iceland, Liechtenstein and Norway)
EMA European Medicines Agency
EU European Union
ICF Informed Consent Form
IMP Investigational Medicinal Product
LVLP Last Visit Last Patient
MREC accredited Medical Research Ethics Committee
MS Member State
MSC Member State Concerned
PIP Pediatric Investigation Plan
RMS Reporting Member State
RSI Reference Safety Information
saMS Safety assessing Member State
SIS Subject Information System
WMO Dutch Act on Medical Research Involving Human Subjects