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Safety Monitoring and Reporting
The automated adverse event (AE) processing module coordinates the activities of AE data collection, reporting, medical safety monitoring, and filing of safety reports. In this module, AEs are reported through the study website within a specified timeframe. In order to implement expedited safety review and reporting, all Serious Adverse Event (SAE) reports are required to be submitted into the WebDCU™ system within 24 hours of first knowledge of the SAE. The submission of the SAE report will trigger an automated email notification sent to the study project manager, the independent medical safety monitor (MSM), and other appropriate trial managers. The project manager will query the site via WebDCU™ for additional information or corrections to the SAE information, if needed. The MSM will enter into the database his/her agreement or disagreement with the SAE as reported by the site in regards to the event’s relatedness to the study treatment and whether the event was expected or unexpected. Should the MSM need additional subject data to conduct the review, those data will be accessible in WebDCU™.

Should the SAE meet the requirements for expedited reporting to regulatory authorities, a safety report (e.g. MedWatch) is automatically generated and populated with data pulled directly from the CRFs. Sites are automatically notified when a safety report has been submitted. Sites can access the safety reports from WebDCU™ for submission to their local IRB.

Medical Coding
WebDCU™ provides a standard coding for adverse events (AEs) and medications with MedDRA and WHO Drug or other selected coding dictionaries. It supports verbatim code algorithms, with the options for automatic removal of stop-words, automatic code propagation, and interactive modification of original text.

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