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 |