Electronic Data Capture (EDC) or electronic Case Record Form (eCRF) systems

Most EDC systems are nowadays web-based to support multi-center clinical studies in an easy and user-friendly manner. Key functionality of such an EDC:

• a graphical user interface to easily organise the study and enter/capture the data, often organized as electronic forms, the “eCRFs”;
• data entry validation functionality to check the entered data for input errors and consistency according to the clinical protocol, e.g. whether numerical values are in range, or whether text input is included in the list of allowed values;
• export/reporting functionality to support the analysis of the data; the primary analysis of the clinical study is usually done in tools external to the EDC, e.g. in statistical tools such as SPSS or SAS;
• overview of the progress of patient inclusion in the study;
• monitoring and control functionality such as audit trails preventing unauthorized changes of data, and tools to support more formal clinical trial processes such as the monitoring of the study, and adverse events reporting;
• technical control measures to support the secure protection of patient data, as required by the European data protection regulation GDPR.

High-end EDC systems are widely used in the pharmaceutical industry and contract research organizations (CROs) contracted by these companies, but also smaller-scale investigator-driven studies are nowadays managed within EDC systems. While the first generation of EDC systems required dedicated IT staff to program the eCRF forms for each clinical study, most modern EDC systems support do-it-yourself form building as required for smaller investigator-driven studies where one data manager or even a PhD student is often responsible for the entire study management. Furthermore, modern EDCs facilitate the reuse of existing eCRFs which simplifies the eCRF generation for researchers and improves the over-all interoperability of the data between studies.

Users can also make use of the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major EDCs. To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.

Most of the larger clinical research institutions in the Netherlands have acquired site licenses for one of the leading EDC systems. Most of these institutional software licenses also allow for participation from scientists from partner institutions in case of multi-center studies.

The majority of Dutch University Medical Centers (UMC) have a site license for such tools, and in some cases even an obligation for studies to make use of Castor (UMCU) or REDcap (UMCG). Even if not the case, when faced with the choice of selecting an EDC system it is usually recommended to make use of these institutional licenses.

An overview of local experts, contact persons and available EDC tool site licenses can be found in this overview.

Overview of common EDC solutions:

Castor:
A popular Dutch solution, which is rapidly expanding internationally (paid version).  
More information here: https://www.castoredc.com/electronic-data-capture-system/.

An overview of local experts, contact persons can be found in this overview

REDcap
A free (mostly) publicly available solution, which can be hosted on private hardware (license restrictions may apply when serving other institutions). More information here: https://www.project-redcap.org/.

An overview of local experts, contact persons can be found in this overview

LibreClinica
The LibreClinica project was founded in 2019 to work on an open-source electronic data capture (EDC) system for clinical trials based on the OpenClinica® (OC) 3 community addition. Not only is it possible to migrate the complete OpenClinica study structure, data, and audit trail; but the updated components of LibreClinica makes it more sustainable and minimizes potential future security risks when compared to the current open-source version of OpenClinica.

A central LibreClinica server is temporarily hosted by Health-RI until December 31^st, 2023 for TraIT OpenClinica migration purposes only. More information available here: https://www.health-ri.nl/trait-openclinica-phasing-out.
If you wish to use LibreClinica for new clinical trials please contact the servicedesk@health-ri.nl for more information on the LibreClinica experts in the Health-RI network.

Research Manager 
Dutch solution used, amongst others, by Isala Zwolle. More information here: https://my-researchmanager.com/en/home-2/.