April 16, 2015
The next release of updates to ESTR* is scheduled to take place after 6pm on April 16. This release is focused on aligning two Harvard custom features with the vendor upgrade path. You will notice the following key changes after this release:
- 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 information needed 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 minor changes:
- Turkey is available to select as an international site on the SmartForm.
- Continuing Review reminder notifications include direct links 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, and current training materials and resources, please visit our support site: estrsupport.fss.harvard.edu
*What is ESTR?