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The Role of the Data Manager in Advancing SAE Reporting from Paper to EDC: Part 1

The Role of the Data Manager in Advancing SAE Reporting from Paper to EDC: Part 1
09 September 2016

By Lucy Spencer, Manager of Clinical Data Management

The sweeping shift in clinical trial reporting from paper to electronic data capture (EDC) has brought with it some generally accepted conclusions – the primary and least debated of which may be that EDC results in faster access to data. However, to date, one vital component of clinical trial data management has been largely left behind in this shift: that of the collection, processing, and reporting of serious adverse events (SAEs.) Ironically, the very nature of SAE reporting that lends itself to EDC is also what has held many organizations back from its implementation, that is, the time sensitivity surrounding the reporting of this data and the criticality of the data. By understanding the reasons underlying the lack of progress in moving SAE reporting to EDC, and then considering the benefits and challenges associated with this paradigm shift, data management can effectively work towards a solution.

In assessing the reasons SAE reporting has largely trailed the industry trend from paper to EDC, it is helpful to acknowledge the inherent dif- ference between safety and non-safety data. This distinction lies in the regulatory reporting requirements of SAEs based on seriousness, expect- edness, investigator reported relationship, and country specific legal re- quirements. The urgency of this safety data is such that the success of the trial and well-being of its participants is quite literally dependent upon timely, accurate reporting to regulatory authorities. Consequently, safety personnel often possess areas of expertise far different from their data management colleagues and are too frequently excluded from database development activities.

The stringent reporting requirements and separation of many safety teams from data management are possible contributors to the lack of safety process integration with EDC. Another often cited factor is familiarity with current processes. Choosing the lesser of two evils, many organizations will stick with a reliable, yet outdated, fax or paper based system over the looming unknown that comes with shifting existing processes to EDC. When faced with the increased importance of the safety reporting task to the drug development process, this apprehension is understandable.

Benefits of SAE Reporting in EDC
Clinical data management must take an active role in progressing SAE processing within EDC and advocate the collective benefits such a shift would bring. Primary among these benefits is the tangible time savings for the clinical site in elimination, or vast reduction, of redundant clini- cal data entry. Traditional paper SAE reports require the clinical site to document a large quantity of data that is available elsewhere in the EDC; notably, demographic, medical history, study drug administration, and concomitant study drug data, among other data. This reduction in redundant reporting will not only save considerable energy in data entry efforts on the part of the site, but also significantly reduce the need for costly and lengthy data reconciliation by data management.

Also of wide benefit to multiple functional areas is the standardization of systems. With many study sites participating in large numbers of clini- cal trials, integration of processes is of real benefit to the end site user. Harmonizing entry and verification processes of safety and non-safety data within a unified EDC database is logical and beneficial from the site and clinical perspective.

If configured well, integration of SAE reporting within EDC can also facilitate data handling workflows (Figure 1.) Notification of initial SAEs can trigger automated safety alerts to both sponsor safety groups, as well as other applicable parties such as contract research organizations, resulting in real-time notification. Additionally, query workflows that have existed peripherally to the clinical database can be managed within the EDC, providing a comprehensive audit trail of query activity. With data cleaning integrated within the EDC, greater visibility can be obtained to this key safety data and with this visibility, heightened emphasis on query turnaround times and the potential for shortened safety case processing times.

Stay tuned to for part 2 and learn about the challenges of SAE reporting in EDC!

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