Whitepaper: eCRF data integrity after a study design change

Learn how Viedoc maintains data integrity when changing the study design or capturing eCRF data in this whitepaper.

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About the whitepaper

In an ideal situation, the study design assigned at the study start is perfect. However, design changes are necessary for most studies, for example, when there is an error in the study configuration. Regulatory inspectors do not expect all CRFs to be flawless, but they do want transparency and traceability.

This leads us to the following questions: How do we maintain data integrity when changing the study design or capturing eCRF data? And when are these changes needed?

We examine these questions and explain how Viedoc makes it easy to perform these tasks while maintaining data integrity in our latest whitepaper.

What’s inside?

• Information about the two different approaches to changing an applied study design:
  • creating and applying a new version
  • revising the existing design version
• Access to all the necessary information you are expected to know after a study design change.
• Advice regarding both creating new versions of a study design and revising an existing version.

And, of course, everything in Viedoc is fully audit-trailed. The Viedoc way – user-friendly, flexible, and always compliant.