In rare occasions, EHR data that was already submitted to the EDC system may change. Our EHR connector doesn’t automatically solve that problem. Instead, we recommend Sponsors and Sites to follow their current processes to account for those changes.
Instead of blindly importing EHR data into your EDC, the algorithm allows you to match real world visits and data with visits expected in your EDC and protocol. That's the beauty of Clinical Pipe's Time Point Matching. It gives you the confidence in knowing that when you import your EHR data it going to be 100% clean, in fact, certified 100% clean by your EDC.
No more transcription errors, no more patient data errors, no more transcription review. You don't have to change your existing data review tools. You retain all ability to run edit checks and auto queries within your EDC. With the Data Point Matching, you know that the data transmitted by Clinical Pipe is 100% clean because it came right from the sites EHR.
Instead of doing basic SDV on the data, monitoring is now focused on verifying that the timepoint in the EHR matches the expected timepoint based on the protocol Schedule of Assessment. We have a timepoint report that allows the CRA to quickly identify mismatched timepoints compared to the visit actual date. Monitors / CRAs can work with the clinical research coordinator to quickly resolve those issues via EDC-based queries or sticky notes.
All of the audit trail information will exist in both the EDC and EHR systems. In the EDC system, the data entry will be from a user that has access to the subject and the EHR system. In an audit, both systems can be used for audit purposes without having to come to Clinical Pipe.
Please review the FDA regulations and guidance in the Compliance section.