Filling Out the eIRB+ Application
Access to eIRB+ requires registration: See our dedicated webpage with eIRB+ registration instructions.
- eIRB+ uses smart form logic. The Initial (New Study) application is composed of a number of sections. Within some of these sections are “branching” questions which will trigger the display or repression of additional sections depending on they are answered.
- Questions marked with an asterisk (*) must be answered. If they are not answered, you will receive an error message.
- Always save your work. To save information in the application, click the “Save” button found at the top and bottom of the screen.
- The eIRB+ system uses “states” to classify submissions status. Visit our Following your eIRB+ Submission webpage for information on the various study states, like pre-submission, pre-review, and clarifications requested.
- Using your browser’s forward and back buttons will not save your information.
- To move forward, click the “Continue” button found at the top and bottom of the eIRB+ workspace. This will save your information and advance you to the next section. IMPORTANT: Using the browser’s forward button will not save your information.
- To move backwards, click the “Back” button found at the top and bottom of the eIRB+ workspace. NOTE: Your changes will NOT automatically save by clicking “Back”. You must click “Save” prior to clicking the “Back” button in order to retain your information.
- To jump over sections, use the “jump to” feature found at the top and bottom of the screen. This feature is convenient for quickly moving throughout the application. However, remember to go back and complete any incomplete sections you may have skipped over.
- To exit, click the “Exit” button found at the top and bottom of the screen. The system will ask whether you want to save your changes.
Adding Documents and Information to eIRB+
When attaching each file, name it as you want it to appear in the IRB determination letter. Attach the files and relevant information listed below, as appropriate, in the identified eIRB+ section (identified in parenthesis):
Protocol: (Basic Information Section)
- Northwestern protocol or sponsor protocol
Funding Information: (Sources of Funding and Other Support Section)
- Grant applications
Drug Details: (Drugs Section with each drug listed)
- Package Insert/Investigator Brochure
- Verification of each IND number (one of these):
- Sponsor protocol with the IND number
- Communication from the FDA or sponsor with the IND number
Device Details: (Devices Section with each device listed)
- Product labeling/Investigator Brochure
- Device instructions
- Verification of each IDE or HDE number (one of these):
- Sponsor protocol with the IDE / HDE number
- Communication from the FDA or sponsor with the IDE /HDE number
Consent Documents: (Consent Forms and Recruitment Materials Section)
- NU consent form(s)
- Sponsor or lead site-approved consent form(s)
- Verbal script of the information provided orally to participants
Recruitment Materials: (Consent Forms and Recruitment Materials Section)
- Advertisements (including printed, audio and video)
- Recruitment materials and scripts
- Press Releases (when the study is open to accrual)
All Other Relevant Documents: (Supporting Documents Section)
- Approval/Authorization Letters
- Audio/Video/Image Files
- Certificate of Confidentiality
- Certificate of Translations
- Confirmation Email to serve as PI (see PI eligibility above)
- Debriefing Scripts
- Data Safety Monitoring Board Report
- Interview Scripts/Data Collection Tools
- Executed Agreements
- Letters of support from sites where research will be conducted
- Institutional Authorization Agreements (IAAs)
- IRB approval letters or the equivalent from International Sites
- Radiation Dosimetry Form
- IRB-approved consent forms from prior studies
- Non-English versions of materials for participants
- A copy of the most recent IRB approval letter, the most recently approved protocol and consent form(s) from the IRB of record for CIRB submissions.