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Reducing the Burden of Clinical Safety Reporting

EDC prevalence at investigational sites provides opportunity to automate and simplify SAE reporting.

February 1, 2011 | Guest Commentary | Managing AE- and SAE-related activities consumes anywhere from 10 to 20% of a study coordinator’s time. Following the occurrence of an SAE, whether life-threatening or not, a study coordinator can sometimes spend hours monitoring the subject, retrieving the patient’s records and completing requisite paperwork. At the same time, separate paper forms must be filled in and faxed to the study sponsor’s pharmacovigilance team within 24 hours, as required by the FDA and other regulatory authorities.

As the affected subject undergoes subsequent supervision and treatment that can last for weeks, sponsors also request regular updates on the patient’s status and clarification on any missing or incomplete case information in the initial report. Most sites believe the substantial workload makes it difficult to meet study performance targets unless the burden of safety reporting can be eased.

As the stream of SAE paperwork is sent over to the sponsor’s pharmacovigilance team, it is typically re-keyed into a safety reporting system for case management and triage. Any follow-up and updates to case records—often via phone and fax—are also performed manually as the querying and triage cycles progress.

As a result of the data redundancy inherent in this practice, SAE-related information can be scattered across multiple clinical systems and databases, such as electronic data capture (EDC), safety and clinical trial management (CTM) systems. Data management teams are then tasked with reconciling various information repositories to ensure consistency and accuracy, a tedious effort that potentially adds weeks to the close-out time of a study.

Automating Adverse Events

Various solutions have recently been suggested and explored to introduce more automation to this process, including providing sites with direct electronic access to sponsors’ safety reporting systems. However, the use of EDC technology at investigational sites today as a primary interface to report clinical data—with close to 90% of all Phase III trials in the U.S. supported by electronic data capture—offers an elegant alternative to reducing the burden of SAE reporting both for the sites and the sponsors, in addition to facilitating a more effective and accurate pharmacovigilance triage cycle.

An appropriately-designed EDC system can automatically and electronically transmit necessary SAE case data directly to the sponsor’s safety reporting system without additional effort and paperwork, as the demographic, medical history and concomitant medication data are already captured in the EDC system as part of the patient screening process.

SAE case information in EDC is typically updated as the clinical safety events occur. Since most safety reporting systems are built to accept and understand electronic case files that adhere to the E2B—a standard developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)—for transmission of the records to regulatory agencies, an EDC system that “speaks” E2B offers a scalable and interoperable, yet simplified, solution.

In addition to the built-in E2B capabilities, an EDC system that supports the automation of the SAE reporting process should also provide the flexibility and configurability for sponsors and sites to determine what information needs to be extracted and transmitted with or without human intervention.

Given the critical nature and time sensitivity of SAE case information, secure transmission must be ensured with sufficient back up in case of system downtime. Support for electronic querying, triage cycles and case management can significantly shorten query cycle times. Automatic alerts to key personnel when SAEs occur and data is transmitted can also add efficiency to the process.

Using EDC as the single place for investigational sites to report SAEs offers sponsors a multitude of benefits. Besides minimizing reconciliation across multiple safety data sources and eliminating the burden of a redundant and laborious paper process, using EDC for SAE reporting simplifies life for site staff, who will now only need to interface with one electronic system, rather than several. With more complete and accurate safety data transmitted in real time during the first reporting cycle and robust querying capabilities native to EDC, triage cycle time can be greatly shortened. High-quality safety data and an automated process enable pharmacovigilence teams to focus on the evaluation of safety data.

The criticality of safety reporting and the inefficiency of existing manual processes strongly call for a more automated and integrated solution, leveraging the ubiquitous EDC system. With the many apparent benefits to sponsors and sites alike, it is reasonable to believe that the industry will embrace such an efficient alternative in the near future.

Ron Rubinstein is senior director of product marketing at Medidata Solutions. He can be reached at

This article also appeared in the January-February 2011 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.

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