Secondary Use, Medical Record Review, and Non-Human Subject Research
January 10, 2020
The application for Secondary Use, Medical Record Review, and Non-Human Subject Research Determination have been simplified to include only the regulatory questions needed for such submissions and no longer require a separate protocol document. The application itself will now serve as the protocol. For all new submissions, navigate to the Study Assistant Workspace and select create new study. You will now see three options: New Project Application, Secondary Use/ Medical Record Review, and Non-Human Subject Research. Due to the demand for these applications to be available to researchers, the new forms are being released with this update, while educational sessions will be scheduled within the next month. Please contact OHRS with any questions.
Secondary Use and Medical Record Review:
Please note, these will route to ODQ Activation to open the trial in OnCore but will no longer be posted to OncPro.
Non-Human Subject Research Determination Form:
These types of submissions will be given a reference number but will no longer be assigned the five-digit IRB number. In addition, Non-Human Subject Research Determination Forms will not be posted to OncPro or entered in OnCore.
Please note, for existing studies, the old Secondary Use and Medical Record options will remain as view only.