Cutting Red Tape: Direct Data Capture in Clinical Trials

Direct Data Capture benefits patients, sponsors, sites and monitors

We all hate duplicate work. Why do we make our clinical research sites do so much of it? Electronic Case Report Forms (eCRFs) in clinical trials are typically used by research sites to report data that they have already recorded somewhere else (the “source data”). A Direct Data Capture (DDC) workflow allows clinical researchers to record data directly at its point of generation as source, in a way suited for use in the trial database – without further transcription or abstraction.

Direct data capture workflows can cover a variety of situations – it can mean investigator/CRC recording directly at the point of care during a patient visit, capturing data as part of a telehealth visit, via a mobile app, and even be tied to remote monitoring data streams, such as with a glucose monitor.

Why Clinical Trials Use Direct Data Capture

In short, direct data capture benefits patients, sponsors, sites and monitors.

DDC shortens trial timelines and costs by eliminating source data verification (SDV) and other quality assurance activities that only exist to root out manual transcription errors. It removes the burden of duplicate data entry from study staff. Organizations have real-time access to clinical trial data for monitoring. Direct data capture also ensures documentation complies with regulations. For sites, the experience is better; thoughtful, tailored workflows mean improved time spent with patients.

Why Clinical Trials Choose OpenClinica for Direct Data Capture

Conversations with our clients revealed eight compelling reasons that clinical trials choose OpenClinica for DDC:

1.Integration: OpenClinica’s direct data capture is closely integrated with other OpenClinica tools, and perhaps more importantly, with an organization’s existing infrastructure. Other data sources, like external labs or medical devices, are integrated using standard OpenClinica features, such as our eCRF, Unite Bulk Import, Unite Transform, and our suite of REST APIs, avoiding reentry of such data.

2. User Experience: When we build our solutions, OpenClinica prioritizes user experience, the user interface and self-serve capabilities. For DDC, this means it is easier to present timely information to the clinical team, capture data in a seamless manner, and tailor the user experience to the needs of the study, therapeutic area, and clinical context. OpenClinica can:

  • Present tailored information about the participant in summary cards and graphs
  • Simplify navigation in ways that match the clinician workflow
  • Utilize its powerful calendaring rules engine for modeling protocol requirement and focusing the clinician/user with relevant tasks/forms in real time, automatically
    Enable Direct Capture of audio, video, images from within the app, and built in widgets for a wide variety of clinical assessments such as visual analog scales

3. Results: We know OpenClinica’s direct data capture works. Because of the usability of our forms and premium end-user experience, existing clients who use our electronic data capture (EDC) platform have been easily using it for direct data capture.

4. EHR for Source Data: When used along with OpenClinica Unite, users – whether they are field personnel, patients or clinic staff – can automatically pull data that has already been captured in the patient’s electronic health record (EHR).

5. Self-Service: The same easy-to-use form and study designer can be applied to all use cases – traditional eCRF, DDC, ePRO, reducing the need for IT support. The OpenClinica Library function allows these forms to be shared in whole or in part across all of a client’s studies.

6. BYOD: The platform is built on a ‘bring your own device’ model, meaning users are able to enter data using their preferred device(s). OpenClinica also supports an offline data entry mode for circumstances in which live, real-time data entry is temporarily unavailable.

7. Customizability: OpenClinica forms are supported by an extensive range of powerful functions for inter- and intra-form edit checks, calculations, relevance (hide/show) logic, value constraints, and workflow rules, making data entry as user-friendly, seamless, and error-free as possible. An OpenClinica differentiator is our ability to embed charts and summary notes on the participant detail page.

8. Compliance: OpenClinica is a Part 11 compliant system designed for use in GCP-compliant studies. We have years of successful performance in these demanding environments.

9. Cost-effective: OpenClinica’s direct data capture is an efficient, cost-effective and mobile-friendly solution.

Direct Data Capture Is a Tool that Supports Decentralized Clinical Trials

Decentralized clinical trials (DCT) deemphasize the traditional role of the clinical trial site in favor of more direct-to-participant interaction. That’s why many consider Direct Data Capture as a tool that supports DCT. For more information about OpenClinica’s DCT toolkit, see: https://www.openclinica.com/blog/chances-are-youre-already-doing-decentralized-clinical-trials/

Your browser is out-of-date!

Update your browser to view this website correctly. Update my browser now