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 email@example.com.
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 April 2015 include:
- In addition to regulatory elements, a selection of Harvard-specific determinations will be recorded in the ESTR. These “Harvard Special Determinations” will appear in determination letters, as applicable and will allow for simplified reporting by the IRB. Your IRB/IRB Review Specialist will alert you to any additional needed information relative to these determinations as part of the regular review process. However, at this time, additional visibility into these determinations does not represent any new policies or additional requirements.
- The Study Team Member Tab, visible on submission workspaces, has been reformatted to display a dynamic list of study team members which can be searched and filtered, along with more at-a-glance information about the named Principal Investigator and Faculty Sponsor, as applicable.
- Additional more minor changes:
- Turkey is available to select as an international site on the SmartForm.
- Continuing Review reminder notifications include links directly to more specific submission deadline information for each IRB.
As part of the next few updates to ESTR, you will see additional navigation and use changes. To learn more about what is planned for ESTR updates, the schedule of ESTR releases, along with current training materials and resources, please visit our support site: estrsupport.fss.harvard.edu
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.