Sponsor’s key responsibilities under the EU CT Directive

Sponsor’s key responsibilities under the EU CT Directive

Note that this information is indicative only. Please contact us for more detail on Sponsor responsibilities and how we can ensure your study is in compliance with the EU Clinical Trials Directive.

Competent Authority Authorisation and Ethics Committee Approval

The sponsor of the clinical trial must:

  • Request clinical trial authorisation (CTA), amend the request where applicable
  • Allow inspection of premises outside the EU if required
  • Give notice of amendments to CTA, make representations about amendments
  • Give notice of amendments to the protocol
  • Give notice that a trial has ended

Adherence to Good Clinical Practice and Conduct

The sponsor must not conduct a trial or act as a sponsor for a study that does not comply with the conditions and principles of Good Clinical Practice

The sponsor of the clinical trial must:

  • Take appropriate urgent safety measures (with participating Investigators)
  • Ensure Investigational Medicinal Products are available to subjects free of charge

Responsibility for Pharmacovigilance

The sponsor of the clinical trial must:

  • Keep records of all adverse events reported by Investigators
  • Ensure recording and prompt reporting of suspected unexpected serious adverse reactions (SUSARS)
  • Ensure all SUSARs, including those outside the EU, are entered into central European database
  • Ensure Investigators are informed of SUSARs
  • Provide annual list of suspected serious adverse reactions and a safety report

Responsibility for Insurance and Indemnity

The sponsor of the clinical trial must ensure that provision has been made for insurance or indemnity to cover the liability of the sponsor and investigator which may arise in relation to the clinical trial.