If you have any questions, please contact the JHM eIRB at jhmeirb@jhmi.edu or 410-955-3008. May 30, 2009 As part of quarterly scheduled updates, the following changes have been made in eIRB: - New Further Study Action application for Emergency Use – This application is used for approval of emergency treatment with a test article on an approved study with an IDE or IDE in accordance with FDA regulations. For more information on how to access and submit an emergency use FSA, select the "How Do I?" link from the left navigation bar.
- Revisions to the Exempt Wizard – Minor revisions and clarifications have been made to the exempt wizard.
- Continuing Review application – Study Population - If you are tracking participants in CRMS, you may upload the CRMS participant enrollment report.
- Continuing Review application – Reporting Information–A new field has been added to provide clinical trial registration number and site or explain why trial does not require registration.
- New Application - Protocol Information – Clarification that a track changed version of eFormA should be uploaded only if requested by the IRB or for Changes in Research.
- New application - Protocol Information – At question 6.0 allow upload for appendices and/or sub-study protocol.
- New Application – General Information – Planning Phase is no longer an option at question 6.0 as a type of review. A new question has been added at 7.0 – Is this a planning phase application?
- New Application – Support Information – Reference to Johns Hopkins General Clinical Research Center (GCRC) changed to Johns Hopkins Institute for Clinical and Translational Research – Clinical Research Unit (ICTR-CRU).
- Minor revisions to electronic approval letters to include CFR categories for children and exemptions.
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