ETHOS Create New Study Version 2.0 2/2018
Create and Submit a New Study (Detailed Guide) Create and submit a new study in ETHOS by entering information into an online application. A combination of the ETHOS “Smart form,” study protocol, and supporting study documents will help you build a complete application that is ready for IRB review. Before you get started in ETHOS, refer to the New Study Checklist, Investigator Manual, and the Ancillary Review Matrix for guidance on what information will be needed for your study. Once you have prepared your study documents, do the following: 1. Log in to ETHOS. Using your UMN Internet ID and password you will be routed to “My Inbox.” Click “Create New Study” on the left side of the screen to display the first form of the IRB application.
2. Complete the ETHOS application. Provide information pertaining to your study and upload study documents as necessary as you progress through the forms. Use the Continue button in the top right corner of the screen to move to the next page of the form. Be sure to save your work before exiting so that you can return to your application at another time. Important Note: You must complete the Basic Information form and click “Continue” to establish your application in the system and receive a study number. You cannot save and return to your study if the Basic Information form is not complete.
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ETHOS Create New Study Version 2.0 2/2018
Tip: Red asterisks in ETHOS denote required information. You will not be able to submit your IRB application unless you have provided information for all required fields. Help buttons are available for most items to help clarify questions as you work. Tip: If you have used tracked changes to prepare Microsoft Word documents make sure to accept all changes prior to uploading documents for your initial submission. Track changes will be used to communicate changes to study documents both before and after initial study approval. Tip: If this is a reliance or single IRB review related submission, follow the guidance and instructions listed on How to Submit a Reliance Request. 3. Submit the study for IRB review. Once you have completed all sections of the ETHOS, click “Continue” to view the Study Workspace where the study can be tracked using the study workflow. Any actions available to you will be displayed in the activities list on the left side of the study
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ETHOS Create New Study Version 2.0 2/2018
workspace.
Important Note: Until you click “Submit” your study has not been submitted to the IRB. Also, although study team members may create and edit a submission, only the Principal Investigator (or faculty advisor of a student PI) can submit a study in ETHOS for IRB review. 4. Monitor the progress of your study. After you submit your IRB application, the study will be locked for editing and routed to the IRB for review. The workflow will update to the Pre-Review state and IRB staff will communicate as clarifications requested or any modifications required for the IRB to conduct or finalize review.
Questions? ETHOS questions or training requests for departments:
[email protected] General questions and IRB submissions during the transition to ETHOS:
[email protected]; (612) 626-5654
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