In the coming months, you may notice changes to our eIRB submission system, ESTR. These changes are a part of the University’s efforts to align our current version of ESTR with the Click® IRB product. Through this initiative, the Click® IRB product will continue to be customized to our needs and will provide the benefit of sustainable long-term and robust support. Alignment will also ensure that the IRB remains compliant with our accreditors and that all ESTR users benefit from a vendor-supported and hosted system. The alignment will affect the entire, University-wide ESTR system.
Overall, Faculty and Staff will experience minimal change to the current ESTR experience. IRB Staff and Reviewers will experience more significant changes to daily processes and system functionality. Many changes associated with the alignment include substantial system improvements – streamlining of processes, performance enhancements, design and formatting updates, etc. Changes to the system will not alter any IRB policies or the human subjects research application requirements.
We will continue to have bi-monthly ESTR releases throughout 2015. Some of the alignment changes have been nominated as “early release candidates” for advanced transition, and you will see them roll out over the next few months – starting in February 2015. To view the system updates associated with current and past releases, click here: http://www.hsph.harvard.edu/ohra/whats-new-with-estr/
If you have any questions regarding ESTR, the alignment, or system releases, please contacts Kim Serpico at firstname.lastname@example.org.
The IRB teams release new features to ESTR every two months. This release is focuses on upgrading key background and administrative functionality within the IRB system. Highlights of the most recent release from February 2015 include:
- When logging in to harvard.edu, to simplify navigation, your personal page will only display a list of items which require attention. This list includes submissions that:
- Have been prepared and not yet submitted,
- Need your review, or
- Submissions where clarifications have been requested by the IRB and you have not yet responded.
- Visit the IRB Submissions page to view all submissions in any stage of review, including links to active studies where you can create modification or continuing review submissions. For easy navigation, you get to this page in two ways:
- Click the “Submissions” link on the lower-left side of the screen, or
- Click the “IRB” text at the top of the page, on the red bar
- The review-type indicator has been removed from all submission workspaces (i.e. the webpage which displays submission-specific details). This previously appeared just under the blue box on the upper-left side of the screen. Removing this indicator has decreased page-load times.
- ESTR sends notifications to a certain set of default recipients. You can now view a report of all your studies and who is currently set to receive notifications, by navigating to Reports (linked on the lower-left side of the screen) > Custom Reports (linked in the center of the Reports screen) > Study Notification Recipients (second-from-the bottom on the list). You can add to the default list of notice recipients by going to a study workspace and completing the “edit email list” activity.
Highlights from the December 2014 release include:
- Updates to the way ADAMS and ESTR communicate along with enhancements to how Data Security Level is recorded in ESTR.
- Harvard custom-created reports have been moved to the “Custom” tab on the reports page (rather than the “Standard” tab).
- Details have been added to the following reports:
- Studies by initial approval date: DSL display
- All Submissions: DSL, risk and review information
- Studies involving greater than minimal risk: Remove closures and add review type
- Studies which have expired: Faculty sponsor and email address
- Studies with Funding: Add Project PI, GMAS Link, and Project ID
- New Reports have also been created, and are visible to IRB staff only
- Other minor corrections to improve notices and IRB operations.
Highlights from the October 2014 release include:
- To assist with follow up on studies which have expired, the system will no send “post-lapse notice” 14 days after a study has lapsed as a reminder of stay status and required actions.
- The funding selection field on the second page of the study SmartForm has been updated to include only necessary selection fields to conduct a search.
- Recorded Ancillary Approvals will be visible on the main study workspace. Ancillary approvals include those reviews which occur outside the IRB process (such as, ESCRO or HUIT review), where documentation of review is required and are considered part of a complete submission.
- The tab labeled “Documents” which was visible on continuing review submission workspace has been removed. It was intended to display the Continuing Review SmartForm attachments only. Since these documents are available by selecting “view submission” within the continuing review workspace, the additional view was deemed unnecessary.
Highlights release from August 2014 include:
- ESTR notifications have been comprehensively reviewed and revised for greater clarity.
- The Final Page of the SmartForm has been revised to include clear instructions on how to submit an application.
- The document library now includes all blank forms under the “Templates” tab (to access, click IRB on the red menu bar, then IRB Library).
- The Timeout Window has been made larger to fit the HUID and PIN log box in after system timeout (which takes about 30 minutes of not using ESTR).
Highlights release from June 2014 include:
- Typing information into a filter bar no longer automatically triggers the filter. The filter will only trigger when the user clicks ‘Go’ or hits Enter.
- When the form is saved, a ‘Please Wait’ notice briefly appears.
- Exit without saving changes is now a modal box to ensure it is not affected by a browser pop-up blocker. It also has friendlier text buttons.
- For some activities, hovering over the activity will display further information about the activity.
- ‘Read more’ indicators on the workspace history are bold for clearer viewing.
Highlights release from April 2014 include:
- At-a-glance Review Type just below the blue submission state box
- Reminder notifications for applications in Pre-Submission state
- Determination letters will be sent to the entire designated “Email List”
- PI assurance has been added when submitting Modifications and Continuing Reviews
- Access to ‘All Submissions’ in the quick link areas
- Adding a comment will now cause the ‘Modified Date’ to update in the submission workspace
Highlights from the February 2014 release include:
- Three new easy to use buttons: “Create Modification”, “Create Continuing Review”, and “Create Closure”
- Updated Help links to the Harvard support site
- Workspace updates to provide more information about document versions, the IRB contact for each submission, and meeting assignment (for projects that require committee review)
- Exemption Request Form (Consultation with a QA/QI Specialist is required for access to this form)