Report Card: Methods for Managing Lab Norms within your EDC System –
Summary
In addition to information collected directly at the study site, most protocols include laboratory tests and other assessments that are conducted by centralized or external organizations. Using this method, lab data is sent to the sponsor or investigator electronically in a format such as Excel, CSV, XML or SAS datasets in either a cumulative or transactional file. Similar to centrally managing lab normal ranges, this method relies on investment on the front end, but has significant potential for time savings in the long run. This approach is most feasible for large study sites, such as cancer centers or academic research organizations who conduct many trials, using their own local laboratory and can configure a feed from their EMR to the EDC. Both systems are most likely within their own fire wall, which reduces security concerns and the number of protocols that benefit from the integration over time increases ROI (return on investment) for the organization.
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