October 16, 2014
The next release of changes for the Electronic Submission Tracking and Reporting (ESTR) system for IRBs will be completed Thursday, October 23 between 6 and 7 pm.
This release includes key improvements to IRB staff processes surrounding the determination of Data Security Level and a subsequent HUIT review, the addition of a post-lapse notice, bug fixes, and SmartForm and activity enhancements. Among these updates, you will see the following changes:
- To assist with follow-up on studies that have lapsed, the system will now send a “post-lapse notice” 14 days after a study has lapsed. This notice will act as a reminder of study status and required actions.
- The funding selection field on the second page of the study SmartForm has been updated to include only the selection fields required to conduct a search and associate funding to an IRB submission.
- Recorded Ancillary Approvals will be visible on the main study workspace. Ancillary approvals include those reviews that occur outside the IRB process (such as, ESCRO or HUIT review), where documentation of review is required and is considered part of a complete submission.
- The tab labeled “documents,” which was visible on the continuing review submission workspace, has been removed. The purpose of the tab was 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 unnecessary.
Up-to-date and detailed release information, all current ESTR job aids, and training information are available on our support site: estrsupport.fss.harvard.edu