In order to enhance patient safety and the quality of care in clinical research, the collection and reporting of serious adverse events or SAEs are critical.
Experts believe that there is a lack of standardization across the data fields included in the SAE case report forms and paper reporting forms.
To cover this gap, TransCelerate began a Common SAE Fields Initiative that focused on assessing the common core data fields that were collected and reported after SAEs.
For this purpose, a team comprising of experts belonging to various was formed and a multiphase approach was used to aggregate its core list of common SAE fields.
The team performed an SAE field commonality assessment across 1238 data fields that were a part of the master list.
By the end, this master list was converted into 133 unique data fields that would provide a complete clinical picture of an SAE.
The final list of 133 data fields was cross-referenced and compared to the industry guidelines and regulations to ensure maximum compliance with regulatory safety reporting requirements.
3 Key Points
“Developing and adopting an industry-standard around SAE data collection is expected to add inherent value across patients, sites, sponsors, and health authorities. An industry standard is expected to optimize clinical trial safety data collection and provide efficiencies in the SAE data collection and reporting processes, including the potential to reduce the number of SAE case versions required to obtain a comprehensive SAE report” – Karen Outten; executive director, Clinical Trial Safety Reporting, within Global Clinical Safety and Pharmacovigilance (GCS&PV) at Merck Research Laboratories (MRL).
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