Source Data Verification 

Prelude Dynamics continues to enhance our VISION™ platform with crucial features requested by our clinical trial user community. The ability to perform Source Data Verification (SDV) in the context of EDC has become more and more important as we’re migrating away from paper. VISION’s SDV functionality operates at the field level and complements the existing form review capability. How does it work? 

Users who have permission to review forms can activate the SDV feature simply by clicking an icon on the form. When this is done, check boxes appear next to the fields on the form.

 

Check boxes give clinical trial monitors an easy way to see which fields still need to be verified.

 

Check boxes are automatically cleared if the reviewed field is later changed – letting monitors easily see which fields need to be re-reviewed, while preserving the reviewed state of other data entry elements on the formThis is a time-saver for monitors, and saving time saves money! 

These field-level SDV reviews are fully attributed and preserved in the audit trail in a 21 CFR compliant manner. 

 

The audit trail shows information about the user who performed the Source Data Verification.

 

Even though most of our clients use VISION to directly enter data as the source (eSOURCE), in some cases there might be a need for SDV. Let’s consider a few scenarios. 

Transcription of data from paper forms 

First consider the transcription of data from paper forms (or pictures of paper forms) such as subject/owner logs or paper patient reported outcome forms to EDC. In the past, Double Data Entry (DDE) was typically used for situations such as these. SDV is an improved replacement for DDE, especially when used along with a file upload that allows a copy of the original paper form to be uploaded directly to the EDC.  

Review of Adverse Events 

Monitors typically want to review Adverse Events as soon as they are entered into the EDC as part of their safety assurance responsibilitiesOccasionally, investigators haven’t completed all the information in the Adverse Event eCRF because they are still conducting analysis on the possible cause. In cases such as this, Monitors can review the data that has been already entered. When they revisit the form later, they will know which information has already been reviewed. This also works well for Concomitant Medications. 

Want to learn more? Contact us to schedule a demo and stay tuned for news of other new features such as Site Level Batch Data Entry and quick report filters! 

 

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