Click IRB Resources

Reference our Identifying Study Team Members in IRB/RSRB Submissions page for more information.

Click IRB accounts are provided to internal faculty/staff/students once they have completed training in the Collaborative Institutional Training Initiative (CITI). In order for the account to be created:

1. The trainee must enter an accurate University email in the ‘institutional email address’ field in CITI; and
2. The trainee must exist in the University’s student/staff database, with an identification number (e.g., Student ID or URID)

If you are unable to locate a student/staff member in Click IRB:

• Verify the individual is a paid faculty/staff member or a registered student. External collaborators do not need Click IRB accounts. To add external study team members, reference the instructions in the Click IRB Study Staff Guide.
• Verify the individual has completed the University of Rochester’s version of HSP training. HSP training for other institutions is not accepted for internal faculty/staff/students. For more information, reference our Required Training FAQs.
• Verify the individual has entered an accurate University email into CITI (see the ‘institutional email address’ field in the CITI Course Completion Report). Instructions for updating the institutional email field in CITI are available. For more information, reference our Required Training FAQs
• Verify when the individual completed CITI training. Click IRB accounts are not created immediately. New user accounts are usually created overnight but it can take up to 48 hours for this process to occur. Delays can occur when system updates take place.

The PI Proxy designation in Click IRB allows study team members to act on behalf of the Principal Investigator (PI) in the Click IRB system.  This means individuals assigned as a PI Proxy can do everything the PI can do in Click IRB. This includes: submitting modifications and continuing reviews; responding to clarifications; and receiving notifications.  Note:

• Only the PI can assign PI Proxies. PI Proxies can be assigned and updated any time. Assigning the designation does not require submission to the IRB, nor IRB approval.
• PI Proxies can only be assigned on the STUDY workspace. The activity is not available on modification or continuing review workspaces. Instructions for assigning a PI Proxy are available in the Click IRB Study Staff Guide.
• PI Proxies can only be assigned to individual studies. Blanket assignments across multiple studies are not feasible at this time.
• Any member of the study team can be designated as a PI Proxy. Multiple team members can be also be assigned PI Proxy on any given study.
• If a PI Proxy is not assigned to a study, only the PI will be able to submit for IRB review (including re-submission following clarification requests made by the IRB).
• The PI Proxy designation is limited to activities in the Click IRB system. It does not extend beyond the Click IRB platform. Nor does it alleviate the PI of their oversight responsibilities.
• For those PIs who decide to assign study members the PI Proxy designation, OHSP suggests setting forth clear expectations for how the designation should/shouldn’t be utilized.  For example, rather than allowing free rein, a PI may set the expectation that only modifications or responses to clarifications can be submitted by the PI Proxy.
• The submission of new studies requires acknowledgement of the responsibilities of a PI. Thus, OHSP expects the PI to submit the initial submission of a new study themselves, not the PI Proxy.
• OHSP expects students acting PI to assign their faculty mentor/advisor as PI Proxy.

Reference our Document Management in Click IRB page.

Reference our Accessing & Utilizing Watermarked Documents page.

Expiration (or approval end) dates are blank when continuing review of the research is not required. This includes the expiration date identified in the study workspace and watermarked documents.

Continuing review may not be required for research reviewed via an expedited review path. Continuing review is not required when the:

• Research is deemed exempt;
• Project does not involve human subject research; or
• Project involves human subject research but the University of Rochester is not engaged.

When continuing review is not required, study teams are still responsible for submitting:

• All revisions to the research to the Reviewing IRB for review and approval prior to implementation; and
• A closure report (via continuing review) when the research is complete.

Reference our RSRB (IRB) Review Process FAQs for more information.

Reference our Defining & Reporting Subject Enrollment page.

Reference our Reporting Research Milestones in Click IRB page.

First, assess whether you have truly reached all of the research milestones. If, you wish to keep a study open because the analysis described in the study protocol is not yet complete or there is a possibility that you may need to go back and collect additional or edit existing data, simply uncheck the ‘analysis of private identifiable information is complete…’ milestone. Doing so will remove the closure prompt within the Click IRB system.

If you determine that all milestones have been reached, you need to assess if the study needs to remain open in order to accomplish the remaining tasks. Investigators often like to keep the study open with the IRB long after the analysis, as described in the protocol, is complete on the off chance that they want to conduct additional analyses in the future. Note, however, that data analysis is still permitted following study closure provided all identifiers have been removed from the analysis dataset. These identifiers do not need to be destroyed, just removed from the dataset and maintained in a separate dataset. Reference Section 9 of OHSP Policy 502: Types of RSRB Submission for additional information.

Reference our RSRB (IRB) Review Process FAQs for more information.