Pilot Project Advances ECRF, Data Collection Support

In 2025, Clinicum and the Compliance and Data Office (CDO) conducted a pilot project in which researchers received in-depth support in both REDCap and statistical planning. The results provide a clearer picture of how researchers can best be equipped to create high-quality electronic research forms right from the start.

The pilot project was aimed at researchers who were in the early stages of planning their studies and needed support in building structured and well-designed eCRFs. Nine studies participated and were offered ten hours of practical assistance from a REDCap administrator and ten hours with a statistician who reviewed the forms based on the study hypotheses. The ambition was to combine technical and methodological support to strengthen data quality in the long term.

All participating studies took advantage of the REDCap support, averaging six hours. Researchers described the initiative as very valuable and highlighted that it saved time, clarified key settings, and made it easier to understand how the structure of the forms affects the analysis work later on. Two studies also had their eCRFs reviewed by a statistician. This review helped them formulate clearer questions, select relevant variables, and ensure that the data collection corresponded to the study's objectives.

Lessons learned about pace and needs

An important insight from the project is that studies develop at different paces. Several projects did not reach the stage where an eCRF review would have had the greatest effect, which shows that a time-bound package with parallel support is not suitable for everyone. The CDO's large user base, with several thousand active users in REDCap, also means that this type of practical and comprehensive support cannot be offered on an ongoing basis in the same form as in the pilot project.

At the same time, the pilot project identified three areas where targeted efforts can add significant value. The first is to outline the study flow at an early stage. Researchers who had a clear plan for participant flows and study components made much faster progress in REDCap. Therefore, CDO will develop visualizations of different types of study flows, while Clinicum will create a checklist to support the construction of eCRF.

Next step: training and flexible review

The second area is training. Despite good online resources, it takes time to learn a new digital tool. To strengthen researchers' basic skills, CDO is launching new REDCap workshops starting in spring 2026, with both an introductory level and a more advanced session.

The third area concerns the review of data collection forms. Researchers expressed a clear need for this type of support, but only when the study is actually ready for it. Clinicum already offers the possibility to apply for an eCRF review when the forms are completed, and this option will be highlighted more clearly. Both units are also investigating the possibility of creating recurring training courses on building eCRFs, possibly as part of CDO's new workshop series.

The pilot project thus provided both positive feedback and valuable lessons. With new checklists, visualizations, and training courses, researchers now have better conditions for making wise decisions in the early and crucial stages of the research process.

Key conclusions from the pilot project

  • Early planning saves time

    Studies with a sketched study flow moved faster through the REDCap process and were able to make more informed decisions.

  • Greatest effect at the right time

    A combined service with time-bound statistics and REDCap support is not suitable for everyone, as studies develop at different speeds.

  • Need for more basic training

    Researchers are asking for a clear introduction to REDCap. Therefore, CDO will start regular workshops from spring 2026.

  • eCRF review remains important

    Researchers value statistical review of forms, but it must be done when the study is ready. Clinicum's existing application process is therefore being highlighted more clearly.

  • New support tools on the way

    CDO is developing visualizations of study flows, and Clinicum is developing a checklist for eCRF construction to facilitate the work from the outset.

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