IRB Notes from the Chair: A new eIRB is coming soon

Anticipated go-live: Summer 2015

The eIRB upgrade project is in final development with go-live anticipated this summer 2015. This new system will provide a simpler, more understandable and streamlined approach for submitting studies for IRB review.

We continue to look to you for your feedback, which has been critical to the success of this project. We have been holding our User Acceptance Testing (UAT) sessions involving close to 100 testing volunteers from the research community who have helped us test key components of the new system’s initial submissions, modifications and continuing reviews process. With their help, we’ve tested more than 250 hours in the new system. Currently, we are meeting with the study team members to test the electronic submission of Reportable New Information (RNI), which is the system’s way of capturing unanticipated problems, adverse events, protocol deviations, updated Investigators Brochures (IBs), etc.

Research community testers have provided feedback by alerting us to any bugs and identifying other possible areas that may require fixes or improvements. We have incorporated many of the suggestions from your testing and thank you again for your assistance. We will continue to have testing opportunities available. Contact Andrew Perluss and David Holmgren to sign up as a testing volunteer, learn about the system hands on,  and help us with your feedback.

At go-live, existing active/closed to enrollment studies will transfer to the new system; any outstanding modifications or continuing reviews will be finished up in the old system prior to transfer. We may be contacting you for clarifications on study details/status. The old eIRB will remain ‘read only’ for access to the review history and archived documents.

To ensure complete/accurate transfer of existing studies to the new system and optimal operability when everyone is living in the new system, please refer to tips from out eIRB Helpdesk article.

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About the Author

Kim is the Education Administrative Coordinator for the Integrity Department.

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