Main author:

UMC Utrecht

Work Package:

WP3 - Clinical validation studies

PDF file

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.

Published On: June 6, 2023