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Clinical Trials Regulation

Regulation (EU) 536/2014 on clinical trials on medicinal products for human use
32014R0536 · official text on EUR-Lex

Articles

Chapter I GENERAL PROVISIONS

• Article 1 — Scope
• Article 2 — Definitions
• Article 3 — General principle

Chapter II AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL

• Article 4 — Prior authorisation
• Article 5 — Submission of an application
• Article 6 — Assessment report — Aspects covered by Part I
• Article 7 — Assessment report — Aspects covered by Part II
• Article 8 — Decision on the clinical trial
• Article 9 — Persons assessing the application
• Article 10 — Specific considerations for vulnerable populations
• Article 11 — Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
• Article 12 — Withdrawal
• Article 13 — Resubmission
• Article 14 — Subsequent addition of a Member State concerned

Chapter III AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL

• Article 15 — General principles
• Article 16 — Submission of application
• Article 17 — Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
• Article 18 — Assessment of a substantial modification of an aspect covered by Part I of the assessment report
• Article 19 — Decision on the substantial modification of an aspect covered by Part I of the assessment report
• Article 20 — Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
• Article 21 — Substantial modification of aspects covered by Parts I and II of the assessment report
• Article 22 — Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report
• Article 23 — Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
• Article 24 — Persons assessing the application for a substantial modification

Chapter IV APPLICATION DOSSIER

• Article 25 — Data submitted in the application dossier
• Article 26 — Language requirements
• Article 27 — Update by way of delegated acts

Chapter V PROTECTION OF SUBJECTS AND INFORMED CONSENT

• Article 28 — General rules
• Article 29 — Informed consent
• Article 30 — Informed consent in cluster trials
• Article 31 — Clinical trials on incapacitated subjects
• Article 32 — Clinical trials on minors
• Article 33 — Clinical trials on pregnant or breastfeeding women
• Article 34 — Additional national measures
• Article 35 — Clinical trials in emergency situations

Chapter VI START, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL

• Article 36 — Notification of the start of a clinical trial and of the end of the recruitment of subjects
• Article 37 — End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
• Article 38 — Temporary halt or early termination by the sponsor for reasons of subject safety
• Article 39 — Update of the contents of the summary of results and summary for laypersons

Chapter VII SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL

• Article 40 — Electronic database for safety reporting
• Article 41 — Reporting of adverse events and serious adverse events by the investigator to the sponsor
• Article 42 — Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
• Article 43 — Annual reporting by the sponsor to the Agency
• Article 44 — Assessment by Member States
• Article 45 — Technical aspects
• Article 46 — Reporting with regard to auxiliary medicinal products

Chapter VIII CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS

• Article 47 — Compliance with the protocol and good clinical practice
• Article 48 — Monitoring
• Article 49 — Suitability of individuals involved in conducting the clinical trial
• Article 50 — Suitability of clinical trial sites
• Article 51 — Traceability, storage, return and destruction of investigational medicinal products
• Article 52 — Reporting of serious breaches
• Article 53 — Other reporting obligations relevant for subject safety
• Article 54 — Urgent safety measures
• Article 55 — Investigator's brochure
• Article 56 — Recording, processing, handling and storage of information
• Article 57 — Clinical trial master file
• Article 58 — Archiving of the clinical trial master file
• Article 59 — Auxiliary medicinal products

Chapter IX MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS

• Article 60 — Scope of this Chapter
• Article 61 — Authorisation of manufacturing and import
• Article 62 — Responsibilities of the qualified person
• Article 63 — Manufacturing and import
• Article 64 — Modification of authorised investigational medicinal products
• Article 65 — Manufacturing of auxiliary medicinal products

Chapter X LABELLING

• Article 66 — Unauthorised investigational and unauthorised auxiliary medicinal products
• Article 67 — Authorised investigational and authorised auxiliary medicinal products
• Article 68 — Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
• Article 69 — Language
• Article 70 — Delegated act

Chapter XI SPONSOR AND INVESTIGATOR

• Article 71 — Sponsor
• Article 72 — Co-sponsorship
• Article 73 — Principal investigator
• Article 74 — Legal representative of the sponsor in the Union
• Article 75 — Liability

Chapter XII DAMAGE COMPENSATION

• Article 76 — Damage compensation

Chapter XIII SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS

• Article 77 — Corrective measures to be taken by Member States
• Article 78 — Member State inspections
• Article 79 — Union controls

Chapter XIV IT INFRASTRUCTURE

• Article 80 — EU portal
• Article 81 — EU database
• Article 82 — Functionality of the EU portal and the EU database

Chapter XV COOPERATION BETWEEN MEMBER STATES

• Article 83 — National contact points
• Article 84 — Support by the Agency and the Commission
• Article 85 — Clinical Trials Coordination and Advisory Group

Chapter XVI FEES

• Article 86 — General principle
• Article 87 — One payment per activity per Member State

Chapter XVII IMPLEMENTING ACTS AND DELEGATED ACTS

• Article 88 — Committee procedure
• Article 89 — Exercise of the delegation

Chapter XVIII MISCELLANEOUS PROVISIONS

• Article 90 — Specific requirements for special groups of medicinal products
• Article 91 — Relation with other Union legislation
• Article 92 — Investigational medicinal products, other products and procedures, free of charge for the subject
• Article 93 — Data protection
• Article 94 — Penalties
• Article 95 — Civil and criminal liability

Chapter XIX FINAL PROVISIONS

• Article 96 — Repeal
• Article 97 — Review
• Article 98 — Transitional provision
• Article 99 — Entry into force