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. 2009 Dec;6(6):618-27.
doi: 10.1177/1740774509348525. Epub 2009 Nov 4.

Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial

Margaret C Bell  1 , Patricia R Robuck, Elizabeth C Wright, Marina S Mihova, Charlotte Hofmann, Jennifer L De Santo, Susan L Milstein, Pamela A Richtmyer, Janel L Shelton, Maureen Cormier, Debra L King, Choon J Park, Wallis A Molchen, Yoon Park, Michelle Kelley
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Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial

Margaret C Bell et al. Clin Trials. 2009 Dec.

Abstract

Background: Even though adverse event (AE) collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines specifying how to summarize the event for reporting in a timely and expeditious manner. This article details the AE and serious adverse event (SAE) reporting summary developed for a large multi-center National Institutes of Health (NIH)-sponsored clinical trial.

Purpose: To review and analyze the large volume of AE data reported by 10 sites (806 SAEs and 19,034 AEs from August 2000 to May 2007) the automated SAE summary was developed. It was designed to ensure timeliness and clarity in the complex process of AE review and reporting.

Methods: The AE and SAE case report forms (CRFs) as well as the automated SAE summary were developed within a database management system developed by the Data Coordinating Center (DCC) which allowed for web-based data entry at the DCC and 10 sites and offered immediate overall and site-specific reports accessible by the DCC, site, and NIH project staff.

Results: The automated SAE summary pulled data from multiple CRFs to create a succinct and informative summary and allowed for prompt and easy reporting to the regulatory agencies. The summary was adaptable to the needs of reviewers because of the availability of multiple search options.

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Figures

Figure 1
Figure 1
Flow chart of the process of adverse events reporting
Figure 2
Figure 2
Automated SAE Summary Output
See this image and copyright information in PMC

References

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