The basic process for either a modification or continuing review is shown in the following diagram. The exploded view shows what occurs during the IRB review process.
The legend indicates who can take major actions during each state within the process. Keep in mind that the diagram does not show all possible paths that a submission may take. The diagram shows the most likely path through the review process with common options identified.
Modifications and continuing reviews include optional ancillary reviews that can be conducted concurrently with the IRB's reviews. For more ancillary review information, see Ancillary Review Overview in the Ancillary Review Guide.
Modifications and continuing reviews must be created, submitted and reviewed as separate submissions, even if they are created and processed at near the same time.
A study closure can only be requested via the continuing review form. When prompted for the submission type, the study team must select continuing review to proceed and provide the needed information for the IRB to consider study closure.
When a study is approved, the system copies the approved study to create a draft study. When a modification is created, the draft study is updated with the proposed changes, while the approved study remains unchanged. When the modification is approved, the changes are published into the approved study.
A modification can apply to the study team membership, to the other parts of the study, or to both. The system allows only one modification at a time to each part of the study. For example, you cannot open a modification of study team membership if the study already has an open modification applying to study team membership or to the entire study.
Note: When reviewing a modification that may change the status of a study from Not Human Subjects Research or Human Research, Not Engaged to an Approval (by full committee, on an Expedited basis, or by way of an Exemption determination), consider copying the study to review the changes on a new record. Changing review type from Not Human Subjects Research or Human Research, Not Engaged to Approved can sometimes disrupt anticipated activities/views on the main study workspace.
Pre-Review for Modifications and Continuing Reviews
Pre-review information populates with the last form entries, and is able to be edited with each submission type. Entries to pre-review activity fields on a modification or continuing review will update the study’s pre-review information once the modification or continuing review is approved.
Since the pre-review entries may be altered with these types of submissions, in post-review, IRB staff are provided with different determination letter templates depending on the type of review and type of submission.
|TIP||If creating a continuing review or modification on behalf of the study team, the IRB staff member can create the submission but will be unable to make edits at first. Save the initial page, exit and assign the IRB Coordinator. Only the assigned IRB Coordinator can make edits to a submission on behalf of the study team.|
Study Closure through Continuing Review
When a continuing review form indicates that the top four research milestones listed on the form have been met (study is permanently closed to enrollment/never open for enrollment, all subjects have completed all study-related interventions, collection of private identifiable information is complete, and analysis of private identifiable information is complete), the parent study is closed automatically when the Continuing Review submission is approved. The top milestones indicate that all enrollment, interventions, and handling of subjects' private identifiable information is complete.
During review of the Continuing Review, if other elements of the submission indicate that the study team would like to keep the submission open for IRB review when it otherwise qualifies for closure (AND the first four research milestones are marked), IRB staff may request clarifications or (depending on the state of the submission) determine “modifications required to secure approval” on the Submit Designated Review activity to allow for a milestone to be de-selected. This will allow for regular continuing review to proceed. For any changes such as this, it is recommended that the special continued review request be explained in the progress report attached to the continuing review SmartForm.
To close a study during the regular continuing review process:
- Check to ensure that there are no other follow-on submissions in mid-review (such as a Modification, Site, or RNI in mid-review). If any are in review, complete the Discard activity on those submissions. If these are not discarded, the system will automatically discard them upon closure.
- Complete the Designated Review form indicating that the submission is Approved Expedited under category “Other”. Additionally, on the Designated Review Form, indicate the approval, effective and last date of approval dates as the same day of determination.
In the Post-Review state for a study being closed, the study closure letter template is presented instead of the approval template. Upon completion of the Send Letter activity, an e-mail notification is sent to inform the PI that review of the submission is complete.
Administrative Closure Process
Based on IRB policies and procedures, a study may be administratively closed by IRB staff.
To administratively close a lapsed study:
1. Navigate to the study, see Accessing a Submission.
2. In the main study workspace select “Close Study (Admin)” from the ‘Next Steps’ section on the left side of the screen.
Note that this option will not appear on a main study that is still in review or which received a “Human Research, Not Engaged” or “Not Human Subjects Research” determination.
3. A pop up will appear that asks if you want to permanently close the study. Additionally, the pop up will provide a list of modification and continuing review submissions that are pending on the study. This will prompt you to review any pending items before you administratively close the study. If you close the study, any open Modifications and Continuing Reviews will automatically be discarded. RNI submissions or Sites will not be discarded automatically.
4. If you wish to proceed with an administrative closure, add any comments you like to the Comment box and then click “OK.”
The study will transition to a Closed state and an automatic notification is sent to the PI, PI Proxy and Primary Contact.