CTTI’s latest research indicates that a single, internet-based portal for investigator reporting of expedited IND safety information to sponsors would be better than the current system of each sponsor having a separate portal. However, until use of a central portal is feasible, the recently published findings and CTTI recommendations provide desired attributes that can promote consistent functionality across electronic portals, improving the quality and use of these systems.

Electronic portals can increase efficiency and lower costs associated with processing safety reports in clinical trials, as well as add an element of security. However, there can be challenges associated with use of these systems that prevent successful adoption. CTTI’s IND Safety Advancement Project sought to identify obstacles and to create recommendations for best practices for following FDA requirements and guidance on expedited safety reporting. Electronic portals are one method sites and sponsors can implement to help adhere to FDA requirements and improve the quality of safety reports.

The recommendations for electronic portals for IND safety reporting are based on results from interviews with research staff, along with multi-stakeholder input on how to address the challenges raised. For example, CTTI found that many research staff report difficulties in tracking multiple passwords and managing different interfaces for various sponsor portals. These research staff views helped to inform strategies that could decrease the burden of IND safety reporting in clinical trials.

For those in the clinical trials enterprise seeking to streamline IND safety reporting, additional recommendations are available from CTTI to improve IND safety assessment and communication.