This blog post highlights the ready-to-use SMART-TRIAL module for Adverse Events (AE) and Serious Adverse Events (SAE). We dive into how the reporting module benefits clinical studies.
Prior to the use of Electronic Data Capture (EDC), most data collection methods included complex paper-based forms. Coupled with the lack of communication and poor resources the process proved inefficient and time-consuming.
One of the barriers in AE reporting is the disconnect between the moment an AE occurs to its reporting. Especially when using outdated methods of data collection that do not allow for good communication between the involved parties.
However, with the widespread adoption of EDC and its continuous development, the MedTech industry stands to benefit. EDC helps comply with regulations and maintain structured quality and safety reports for products on the market.
The benefits are without a doubt a massive improvement compared to current paper-based standards.
In SMART-TRIAL there are five stages that all AE/SAE reports follow, i.e. Event reported, Investigator Assessment, Sponsor Classification, Followed-Up, and Sponsor Sign off.
During Event Reporting, a user creates a new AE/SAE report, which includes all of the general information of the event. This is usually information that clarifies date of awareness, if it’s serious or normal AE, description of the event etc.
Investigator Assessment refers to fields in the AE/SAE report that are filled out by the investigator. These fields involve classification of the intensity and the relationship of the AE/SAE to the procedure and the device.
Sponsor Classification is the classification made by the sponsor of the study. Like the investigator, the sponsor will classify the intensity and relationship to the procedure and device. Further, the sponsor will also determine if the AE/SAE is anticipated, classify the event (AE, SAE, ADE, ASADE, or USADE), and provide information about the current location of the device.
Followed up is the stage of every report, where a user has to complete the report, by following up with the subject on the potential outcome of the event. This usually includes information such as outcome results and end-date.
Sponsor Sign off is the last step in reporting AE/SAE’s and involves that the sponsor signs off with their name that all information in the report is provided correctly and this concludes the AE/SAE flow.
For a more detailed explanation of each step you can visit our help site
In addition to being able to collect the standard AE/SAE information, you can also link events with concomitant medications from the SMART-TRIAL medication module. This provides an even better overview of subject’s progress in the study.
Conclusively, when evaluating EDC solutions for clinical studies, one often forgets to evaluate the interoperability of the EDC with AE/SAE reporting.
But with SMART-TRIAL’s user-focused design, that makes full use of its EDC capabilities, you can increase data quality and overall efficiency of your AE/SAE reporting process, both for clinical studies and post-market surveillance.
The SMART-TRIAL AE/SAE module is available for all eCRF licenses that need to use its functionality. With a ready-to-use module, you not only minimize the setup time of your EDC, but you also gain added functionality which offers a more streamlined progress tracking of your AE/SAE reporting.
Interested in trying out these features?