The benefits of electronic CRFs (eCRFs) over paper-driven trials are well known. The use of eCRFs has the following main advantages:

• -Faster and cleaner data entry by sites
• -Remote site support and management
• -Flexible and enhanced monitoring
• -Integration of paper and computer entered data
• -Coordination of all subject data in one database (lab reports, IVRS, etc.)
• -Real-time reporting on both operational and clinical data

However due to the complexity of such systems and the strict legal requirements such systems need to fulfill, most e-CRFs on the market are quite expensive. Since a few years open source eCRFs are on the market which fulfill all the legal requirements. LibreClinica is such an excellent open source eCRF. The use of LibreClinica is quite simple. Nevertheless a good documented training of site staff and CRAs is part of the required validation process which ensures high data quality.

Other topics are: your "Home" in LibreClinica, adding Study Subjects, shortcuts for quickly accessing a Subject, Scheduling Events, elements in the CRF-screen, required fields, Validations and error-messages, adding Notes, handling Discrepancies, marking CRF Complete, signing Subjects, etc.