2024 OpenClinica-SCDM journal eCRF article-banner
Clinical Trial Technology

Efficiency & Quality: The Impact of CDASH eCRFS & OpenClinica EDC on Clinical Trials

Five key points

It’s my privilege to share with you the article, Dissemination of CDASH eCRFs via the CDISC Electronic Case Report Form (eCRF) Portal and the OpenClinica Electronic Data Capture system.

Undoubtedly, the article was a labor of love.

One year after the Journal of the Society for Clinical Data Management (JSCDM), the society’s open access, peer-reviewed publication, published our article on June 1, 2023, there have been nearly 1,110 views and 270 downloads – and growing.

In other words, more than a thousand clinical trial professionals are interested in the implementation of validated case report form (CRF) content using the Clinical Data Acquisition Standards Harmonization (CDASH) eCRF Portal within an electronic case report form (eCRF) content library in the OpenClinica Electronic Data Capture (EDC) system, and especially the many potential benefits, which include:

  • Improving the efficiency of study designers,
  • Promoting greater adoption of high-quality standards,
  • Decreasing delays in design and study implementation,
  • Lessening protocol amendments,
  • Achieving faster implementations,
  • Reducing study start-up costs, and
  • Realizing greater reusability of data.

CDASH eCRFs: The Five Key Points

Five of the key points in our JSCDM article about CDASH eCRFs are:

  1. Implementation

    The forms are created using CDASH standards, which ensure consistent data definitions and controlled terminologies across different studies. The forms are integrated into the OpenClinica EDC system, allowing for easy use and customization by researchers.

  2. Naming Conventions

    Unique identifiers (OIDs) are used for each item and form to maintain consistency and avoid conflicts. Labels and notes within the forms are designed to be user-friendly while maintaining traceability to CDASH standards.

  3. Form Logic

    The eCRFs include skip logic and relevant rules to streamline data collection. This ensures that only relevant data is collected based on prior responses, enhancing the efficiency and accuracy of data entry.

  4. Dissemination

    The eCRFs are made available through the Clinical Data Interchange Standards Consortium (CDISC) eCRF Portal and can be easily accessed and implemented in studies using the OpenClinica platform. The system supports the dissemination of these forms by including them in a content library accessible to all users.

  5. Ongoing Work

    The article highlights 33 Foundational CDASH domains that have already been implemented and mentions efforts to include an additional 20 disease-specific forms.

For more detailed information, read the full article here.

Looking ahead, I was chosen to chair a session at SCDM Annual Conference, September 29-October 2, 2024 in Boston. The panel discussion, EHR eSource: The way of the future or pipe dream, takes place October 1, 12:00 – 1:00 pm. Stay tuned for more details about how to meet us in Boston this fall.

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