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Oracle Introduces Remote Data Capture Onsite 4.5.3 With Extensive New Functionality for Investigative Site Personnel
Date:3/3/2008

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Improved Patient Data Report

Oracle Remote Data Capture Onsite 4.5.3 also features a new Patient Data Report that offers significant performance gains and is better tailored for use in electronic submissions. The Patient Data Report provides a single PDF file of all CRFs entered for a single patient and presents data in the same form layout used for data entry. At the conclusion of a study, Patient Data Reports, coupled with audit trail and discrepancy information, provide a certified copy of the data for the investigative sites, and supply the data portion of the eventual submission. The new Patient Data Report also provides substantially improved performance for large-scale trials. To help with electronic submissions, the report includes PDF bookmarks and other features specified in U.S. Food and Drug Administration (FDA) guidelines.

Accuracy Counts

Timely data entry is valuable only if data is recorded accurately in an equally timely manner. To facilitate this process, Oracle Remote Data Capture Onsite 4.5.3 features a robust system of edit checks to help ensure data accuracy and integrity. The system allows users to check accuracy at various stages of the investigation process. First, the system conducts edit checks upon data entry, flagging errors (discrepancies) so that site users can correct problems almost immediately. The patient validation function then executes more complex edit checks, typically relating to data values that do not correlate across CRFs. Finally, if patient validation is not executed, regular (nightly) study-wide batch validation raises the discrepancies that the patient validation would ordinarily catch.

"Data validation issues can significantly delay completion of the clinical trial phase as well as database lockdown," said Jim Streeter, Executive Director EDC, PPD. "The newest version of Oracle Remote Data Capture Onsite offers increased automation by providing edit cache and validation at several steps
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