Safety Report Distribution Now Available via eTools

September 28th, 2017

In response to client feedback, Schulman IRB now offers distribution of Safety Reports and Acknowledgements of Receipt through eTools to equip research sites with pertinent safety information and to expedite and facilitate the submission process for sponsors and CROs. This update is effective October 1, 2017.

This new service makes it easy to build a comprehensive study file by allowing seamless access to necessary files and information. Up-to-date safety data will be available in real time and sites will be able to retrieve SAE information submitted locally as well as Safety Reports that are distributed by sponsors and CROs.

For sponsor and CRO users, the service will mitigate the steps currently taken to distribute safety information to sites. With the submission of a Safety Report, the acknowledgement documentation will be posted for all affiliated sites to access within 3 business days.

”While the IRB only needs to review Safety Reports that meet the criteria for unanticipated problems or unanticipated device effects, we understand that some SOPs still require all reports be submitted to the IRB,” said Eli Alford, COO at Schulman IRB. “We hope that providing acknowledgements of receipt and distributing the reports directly via our eTools helps to streamline the reporting process so researchers can use their time more efficiently and effectively.”

Contact your Study Manager or the Subject Safety Team for more information.