The national competent authorities and the European Medicines Agency are working together to ensure the completeness of the records including the review by the competent authority or ethics committee in the country concerned and the end of trial.
Data quality from 10 March 2011 for protocol related information
The 10th March 2011 launch of version 8.0 of the EudraCT database has put in place a more comprehensive set of validation rules for data entry to ensure greater data completeness and consistency. National medicine regulatory authorities and the European Medicines Agency are also working to ensure timely entry of information.
Version 8.0 of the EudraCT database includes enhanced automated checking and quality control and the increased use of standardised data.
The data quality initiative includes requirements such as:
EU Clinical Trials Register version 2.2