A user-friendly, GCP and GDPR compliant electronic data capture (EDC) system, Castor EDC, will be used to guarantee correct, complete and consistent data collection of the clinical studies of PROMISE Work Package (WP3). Electronic case report forms (eCRFs) will be developed and implemented on the EDC system. By using comprehensive data validation checks within these forms, only data of high quality will be submitted to the study database. The forms, integrated into the EDC system, will be easily accessible by a standard web browser. All study subjects will be identified with a participant identification code in order to safeguard the identity of the participants. The de-identified data will be stored on secure servers. Local teams will log patient identifiable data in a separate secure document to link the subject to the correct ID number noted on the eCRF. The system will meet all GCP and GDPR guidelines for electronic data collection in terms of protecting data integrity and securing the information collected.
The Innovative Medicines Initiative is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is working to improve health by speeding up the development of the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in health research, including universities, research centres, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. IMI is the world’s biggest public-private partnership (PPP) in the life sciences.
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