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Tuesday, September 02, 2014 | 15:57:53 CEST

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Clinical Trials Directive

On 17 July, the European Commission (EC) published a proposal for a Regulation on Clinical Trials, which aims to reduce the adminstrative brude and make it easier to conduct clinical trials between Member States in the European Union.

The EC proposal is based on a public consultation held in January 2010. A report as well as a summary of the consultation are available. The ESR has coordinated a response to the European Commission consultation on clinical trials based on an internal survey.

The regulation proposal presents:

Simplified submissions and cooperation on assessment rules
  • A clinical trial application will be submitted following a common standardised format through a single EU portal, which would centralise applications and forward them to the competent national authorities. The EU portal and database will be set up and managed by the European Commission. The database will be accessible for the public.
  • The proposal introduces a coordinated assessment procedure: All Member States concerned will input to a clinical trial’s scientific assessment. It will be led by a ‘reporting Member State’, which would be responsible for the overall assessment within defined timelines and the centralisation of requests for additional explanation. 
  • Member States will run a parallel assessment for issues under national responsibility such as compliance with requirements on informed consent, data protection of subjects, compensation of investigators and subjects, recruitment and suitability of sites.
  • Each Member State will decide whether the clinical trial is authorised in their country or not.
  • The proposal introduces a risk-categorisation of clinical trials: low intervention trials will benefit from a speedier authorisation and simplified rules for safety reporting and monitoring.
  • The European Commission will set up and manage a Coordination and Advisory Forum to address issues, which may arise in the authorisation procedure.

Safety reporting
  • The proposal gives an increased role to EudraVigilance (EU data processing network and management system for reporting and evaluating suspected adverse reactions). Expedited safety reports will have to be submitted only through the network.
  • The ethics committees' organisation will remain under the remit of national authorities.

Multinational trials
  • The proposal introduces the possibility for co-sponsorship, i.e. several sponsors in different Member States can share the responisbility for a clinical trial.
  • The Commission will have the possibility to conduct controls in Member States to ensure European rules are being correctly implemented.

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For more information please contact eu-affairs@myesr.org



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