gms | German Medical Science

Introduction: Electronic Data Capture Systems (EDCS) are an essential part of recording clinical research data in Electronic Case Report Forms (ECRFs) for human-centered clinical research [1]. EDCS as standalone software often have insufficient integration of binary data like biosignals or imaging data, resulting in inefficient workflows when handling such data [2].

The project goal was to develop an upload tool for large data transfers, which can be integrated into ECRF software. The following requirements were identified:

• Req1: Upload process must be integrated and initiated in ECRF.
• Req2: Upload must be able to work when browser is closed.
• Req3: Upload must resume after system restarts and connection losses.
• Req4: Files to be uploaded should not be copied locally or moved.
• Req5: The Software should be easily maintainable and stable.
• Req6: Must be cross platform.

State of the art: Commonly, EDCS only have direct file uploads, which only survive in a single browser session and have a browser set upload file size [2]. Such file uploads are only suitable for small data uploads, but not sufficient for large data.

OpenBIS is a widespread framework for data management and data analysis in biological Research. Its transfer tool, “datamover”, allows the background upload of large files [3] using command line tools. No EDCS centric solution is currently implemented for OpenBIS. The OC-Big project is an EDCS centered system that allows the browser-based upload to OpenClinica directly [2]. As of today, upload software of the project has not been updated in 8 years [4].

Concept: Based on the requirements and shortcomings of existing solutions, we decided to self-develop a solution.

The requirements of being able to upload outside a browser session and to resume uploads, results in the need of a background process. Additionally, the requirement of not storing large data in the ECRF directly, results in having a separate data server component. This resulted in a three-part approach, an EDCS integration visible in the browser, a component running on a local system with full file system access and background capabilities and a server-side component that acts as a data server.

Implementation: The EDCS integration was planned as a module for the EDCS REDCap [5]. It is visible at ECRFs level. It communicates with the Data Server via a Rest API, displays metadata of the uploads and can initiate new uploads by interacting with the local components by calling them via OS-level registered URI.

The local component was planned in 2 parts: A GUI callable via a URI, which allows selection of the file to be uploaded with a native file chooser and creates a job file. The second part is a background process with a File Watcher, which fetches created job files and uploads the chosen file by interacting with the data server.

Lessons learned: Prototypically, the concept could address the problem of ECRF-centric large file uploads. Major limitations are the local components that need to be installed with administrative rights for custom URI protocol handlers and background services.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.