Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The new Clinical Trial Regulation and corresponding new EU portal and database: an opportunity to enhance standardisation and interoperability in regulatory systems ***

Rita Huber (Abschlußjahr: 2015)

Summary
Language: English
In 2004 Clinical Trial Directive 2001/20/EC came into force to regulate the execution of clinical trials (CTs) in the European Union (EU).
The Directive was a big step forward in regulating the assessment, performance and recording of CTs but experience with the process over the last several years has indicated that a new approach is needed.
Therefore the new EU Clinical Trial Regulation 536/2014 (CTR) was introduced in 2014 (but will not be applied until 2016).
The new Regulation, which replaces the Directive, defines a single submission process for CT applications with an overall streamlined assessment. The current clinical trials database EudraCT will be replaced in the long term by a new EU portal and database for submission and storage of data for clinical trials.
The new portal and database have to be set up as completely new IT systems by the European Medicines Agency (EMA). These systems will be used to collect data about planned and already performed clinical trials. Entry will be made directly via the portal by the sponsor, the Member States of the EU or the European Commission. These data will be stored in the EU database and a great part of the contents of the database will also be made accessible to the public to improve the transparency of clinical trials.
The CTR can only be applied after a positive audit for the new EU portal and EU database has been performed and both have achieved full functionality and meet the functional specifications.
In light of the growing importance of standardisation and interoperability in the EU and worldwide due to the increase of complexity, the rising numbers of systems and the growing amount of data, this thesis analyses the role of international regulatory initiatives in this field for the introduction of the new Regulation. This analysis also includes the different roadmaps of the EU Telematics strategy.
Enhancement of standardisation and interoperability for the new EU portal and database can be achieved by using existing or future international standards.
Especially the use of a standardised structured electronic application form (eAF) for the Clinical Trial Applications (CTAs), the integration of IDMP-compliant standard master data (as supported by the EMA Master Data Management roadmap) and the possible application of submission formats for CTAs such as the future Regulated Product Submission (RPS) standard are opportunities for the implementation of the Regulation.
The opportunities for the use of standards in the new systems make a valuable contribution towards improving the regulatory processes in the EU and ultimately result in a better quality of data relating to medicinal products.
Pages: 48