A Clinical Trial Application (CTA) is a submission to the competent National Regulatory Authority(ies) for obtaining authorization to conduct a clinical trial in a specific country. It is an application with necessary information on investigational medicinal products. The purpose of a CTA is to provide all the important details about the clinical trial to the health authorities in order to obtain the product approval.

In the European Union (EU), the CTAs are regulated under the Clinical Trial Regulation EU No. 536/2014. The regulation intends to set high standards of safety and transparency for the clinical trials conducted. There are four types of CTA:

  • Initial Application – When a sponsor is applying for a new clinical trial in the EU, he/she is required to submit an initial application.
  • Substantial Modification Application – This application is submitted in the case of any substantial changes that are required to be made to an authorized clinical trial.
  • Non-substantial Modification Application – This application is submitted in the case of any non-substantial changes required to be made to an authorized clinical trial.
  • Additional MSC Application – An additional MSC application is required if an extra member state is added to an authorized clinical trial.

Content of a CTA in the EU

Though the content of a CTA differs from State to State, it must consist the following modules:

Part I – Scientific and Medicinal Product Documentation

  • Application form
  • Protocol
  • Investigators Brochure
  • GMP documentation
  • IMPD/AMPD
  • Scientific advice
  • Pediatric Investigation Plan decision
  • IMP/auxiliary labels

Part II – National and Patient Level Documentation

  • Patient materials: informed consent, patient information leaflet
  • Compensation arrangements
  • Recruitment arrangements
  • Investigators and facilities suitability
  • Damage compensation
  • Data protection rules

Assessment of a CTA

Designated regulators from competent authorities are appointed to evaluate the CTAs. The trials are evaluated as per the defined regulations and timelines of the authority in concern.

Being an integral part of the clinical trial approval, it is necessary for sponsors to submit compliant CTA. To know more about CTA and its submission process, reach out to Frey at sales@freyrsolutions.com