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The Role of the Data Manager in Advancing SAE Reporting from Paper to EDC: Part 2 of a 2-Part Series

The Role of the Data Manager in Advancing SAE Reporting from Paper to EDC: Part 2 of a 2-Part Series
15 September 2016

By Lucy Spencer, Manager of Clinical Data Management

Challenges of SAE Reporting in EDC
As with all emerging technologies, considerable work remains to be done to define and refine processes which will meet the specific needs of safety teams and enhance, rather than hinder, the vital daily work they perform.

To date, the largest challenges in implementing SAE reporting in EDC are system limitations. If the EDC system cannot provide the needed documentation and notifications required for the safety case processing cycle, regardless of the preference of the study team, its use is not a feasible option.

If the basic functionalities of the EDC support SAE reporting, considerations must be taken to establish backup reporting methods if the EDC system becomes unavailable. Guidance must be provided as to how supporting documentation (e.g. hospital/discharge letters) will be received; while many EDC systems allow for uploading of documents, safeguards must be in place to alert the safety team if this uploaded documentation is revised. A method must be available to allow for on-demand SAE reports to be printed in PDF format from the EDC system. Lastly, and most importantly, a means must be implemented to highlight new or revised information to the initial SAE report. As a change to seriousness, event term, expectedness, or relationship has the potential to affect regulatory reportability, this component is imperative to the success of any EDC safety reporting system.

Even under ideal circumstances where the EDC system technology can be designed to meet the specific requirements of safety, another real and overlooked obstacle in its success lies in the human component. The timely nature of SAE reporting necessitates updated information at the time of the SAE reporting; however, the reality is that more often than not, the data available in EDC is incomplete. The shift to SAE EDC reporting is one that needs to have the full support of all participants, beginning at the site level, to ensure robust data is available.

The Future of SAE Reporting
With the advent of gateway systems that allow for automated transmittal of EDC safety data to dedicated safety databases, even more efficiencies may be realized. Gateways eliminate manual entry into safety databases by transmitting electronic case files that adhere to the E2B standards developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) directly from the EDC system to an E2B compatible safety system. As data are incrementally transferred from the EDC and capabilities exist to highlight updated information in follow-up reports, follow-up reporting cycles may be significantly streamlined. While this synchronization of data is currently available, considerable work remains to be completed to make it a viable option for many organizations. Especially for those just delving into the SAE reporting shift to EDC, the validation and logistics of a gateway system may put it out of near reach.

In the interim, EDC databases can be developed that offer a multitude of significant benefits through carefully designed AE/SAE EDC forms and advanced programming.

With the recent guidance released in Clinical Data Acquisition Standards Harmonization (CDASH) Serious Adverse Event Supplement Version 1, the shift of SAE reporting to EDC is being recommended by the leading industry authority:

"Electronic data capture (EDC) is recognized as an efficient and time saving method for capturing clinical data. EDC also offers a more efficient process for SAE information capture than the traditional paper form; sponsors can use information already available in the Clinical Data Management System (CDMS) to populate the same data elements on an SAE report form. Typically, such data are housed in a clinical study database. All SAE data that are not extracted from the clinical study database are typically housed in a separate safety database. The relationship between drug safety data and clinical trial data that commonly manifests in two distinct data acquisition processes can be enhanced by minimizing duplicative data collection and easing the safety data reconciliation processes."

While the risks involved with changing methods for a process as critical as SAE reporting are real, the potential benefits arguably outweigh the risks. Progress in this area will not be realized until an open communication between all stakeholders can be broached and integration started. As with many technological advances, data management must spearhead this effort by endeavoring to understand the particular requirements of safety and innovating processes that will make SAE reporting in EDC the new standard. A true collaboration between data management and safety is the key to this success.


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