Six Guidelines for
EDC Study Design

  • You’ve just been handed a protocol and asked to build it out in your EDC. How can you make sure that the protocol is implemented in a way that maximizes efficiency and data quality?

    Getting the details right during the build phase paves the way for a smoother study, generates better data, and keeps stakeholders productive and happy throughout the process.


Key takeaways from this eBook

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    Successfully build your study

    While each study protocol is unique and will have its own needs, there are six proven elements that consistently contribute to a successful build.

  • icon-ppl
    Guidelines for every role type

    How will sponsors, clinical data managers, research coordinators, monitors, sites, participants, statisticians, and other stakeholders be impacted by study design choices?

  • tools-icon
    Keep your study build on-task

    Less is more, and this is especially true in clinical trials. While it can be tempting to pack a study with unnecessary data fields and too much validation logic, learn how to keep it simple!

  • study-design-icon
    Best practices for intuitive study design

    Thinking critically about data collection workflows can help site users deliver better data, faster. Discover how to create a good EDC study design that creates a smooth experience for site users by aligning with existing site workflows.


"For ease of use, efficiency, and UI, OpenClinica is my first pick. The regulatory support package is robust and validation maintenance is simple and straightforward. Development processes are well controlled and the company is at a mature place in testing and compliance. Aside from really nice software, the people are really lovely and provide excellent support."

– President, Biotechnology Company

"Our business requires continuous frequent changes to study design. The OpenClinica design tools make it easy for non-technical resources to make, test, and then deploy changes while maintaining compatibility with previous iterations. In the event that the required form logic is really complex, OpenClinica professional resources are there to assist. The webservices allow us to enroll participants and schedule events in OpenClinica programmatically which is a significant time-saver. This also made integration with existing systems and business processes much smoother."

– Director of IT, Applications and Data

"Having worked with OpenClinica and other EDC systems for several years, OpenClinica puts all the others to shame when it comes to customer service; their team bends over backward to help train, explain, and fix. The software is continually improving based on user feedback. The forms are very powerful and have almost every feature you might need: conditional display, modern responsive interface, touch-friendly, lots of question types, conditional requirement, programmable notes to users."

– Clinical Data Manager
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