Data quality

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 of historical information

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:

• the completion of all relevant fields;
• the entry of data in a timely manner;
• the use of drop-down lists rather than free text, wherever possible.