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| webIRB Program Updates (Release Notes) | |
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Issue ID
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Changes to Forms (Study and Continuing Review)
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1843, 1865, 1858, 1897, 1901, 1902, 1903, 1919
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Added guidance, revised question text and possible answers for clarity, fixed typographical errors, removed unnecessary validation, fixed minor branching issues.
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Issue
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Changes to Activities/Workflow Affecting Study Teams
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1820
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Fixed issue where Continuing Review reminder notifications are sent to study team members too far in advance.
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1906
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Disabled account auto-deactivation based on employee database employee status.
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1873
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Removed "Required" from PI Proxy to allow all PI Proxies to be removed if necessary.
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1904
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Minor wording change to View Letter in history/workflow.
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Issue
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Enhancements to Activities/Workflow Affecting IRB Staff
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1885
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Enhanced workflow for continuing participants during approval lapse, to log correspondence for these decisions to the Study history.
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1905
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Changed areas in the workflow where snapshots are taken.
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1898
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Modified Continuing Review workflow so that Assigned to IRB Meeting state was visible for External Status as well as Internal Status.
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Issue ID
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Changes to Forms (Study and Continuing Review)
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1642, 1653, 1697, 1725, 1748, 1755, 1757, 1778, 1792, 1812, 1813, 1819, 1824, 1837, 1841, 1842, 1844, 1848, 1858, 1860, 1864, 1865, 1868
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Added guidance, revised question text and possible answers for clarity, fixed typographical errors, removed unnecessary validation, fixed minor branching issues.
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Issue
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Changes to Email Notifications and Letters
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1669
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Fixed issues with large text not appearing properly in History tab for Send Letter/Notice to PI activity.
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1857
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Removed redundant information in Continuing Review Approval Notice.
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1836
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Updated Amendment Approval Notice to use New PI name rather than previous PI name in the case where the amendment is to change the PI.
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Issue
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Changes to Activities/Workflow Affecting Study Teams
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1817
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Added Completed IRB Requests tab to the UCLA IRB Review Not Required study workspace.
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1820
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Fixed issue where Continuing Review Email Reminders were sometimes sent after a CR was approved (including issue where a few studies were set to expired in appropriately due to expiration date configuration issue).
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1728
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Display PI Proxies in Workspace for all project types.
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1810
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Added instructions for completing PI Assurances to Submission email notification.
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1855
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Updated permissions such that any member of the study team can withdraw amendments.
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Issue
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Enhancements to Activities/Workflow Affecting IRB Staff
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1807
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Increased number of changes in the Change Log from 10 to 25.
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1872
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Removed Start and End times from Minutes.
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1782
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Added Log Private Comment activity to all project types in all states.
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1828
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Changed name of 8c Condition to Data Analysis Only.
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Issue
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Enhancements to Activities/Workflow Affecting Committee Members/Reviewers
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1775
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Added Meeting Date and IRB Staff Needs Attention Notes to Inbox
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1806
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Increased number of projects in Inbox from 10 to 25
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Issue
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Administrative Changes
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1870
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Added ability to edit PI Proxy if needed by Administrator
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Issue ID
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Changes to Forms
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1720, 1739, 1749, 1771, 1743, 1790, 1741, 1706, 1717, 1713, 1756, 1740, 1830, 1831, 1835, 1845, 1851
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Added guidance, revised question text and possible answers for clarity, fixed typographical errors, removed unnecessary validation, fixed minor branching issues.
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1707
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Fixed issue where removing user from study personnel on page 1.1 of modified study did not remove the user from select lists on later pages of the modified study smartform.
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1708, 1803, 1804, 1805
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Continuing Review: Complete overhaul of smartform to more closely follow the New Study CRC pages, including general attachment field. Caution: CRs in progress prior to this release will appear blank. Review History for Log Private Comment where administration included Snapshot of the CR prior to deployment for reference. If changes are needed by the study team, the new CR will need to be completed – reference snapshot can be used to aid completion of new form.
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Issue
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Changes to Email Notifications and Letters
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1773
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Letter Templates for Study were altered to display only the full title, not the working title, and Version is labeled.
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1752
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Fixed issue where CR reminders were not being sent out properly prior to Study expiration.
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1460
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Updated email notifications to show all recipients in the CC field.
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1742
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Updated Continuing Review Reminder email notifications with instructions for creating continuing reviews in webIRB.
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1721, 1838
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Typos were corrected
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Issue
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Changes to Activities/Workflow Affecting Study Teams
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1037
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For the following activities, the author is set to System Administrator for the log of the activity in the History for a study: Project Snapshot and CM COI.
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1462
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Added a snapshot of the Study (modified study) and Amendment at all the same points in the workflow where snapshots are taken for Study.
Also added snapshots for PAR and CR at final states only (i.e., Approved, Acknowledged).
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1694
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Fixed issue where creating linked amendments sometimes fails due to timeout.
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1696
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Added reminders for Pre-Review Changes Requested status to study team. All functionality works the same as Accepted Pending Modifications as far as timing of reminders and Withdrawal after deadline. Requests for extension are also included.
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1731
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Fixed issue where rarely some study personnel are read only in study in state where they should be editable.
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1753
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Fixed issue where items in PI's court past response required deadline were not always being withdrawn by the system. Note: this withdrawal activity only runs once per week so often the deadline can be overdue by almost a week before it is automatically withdrawn by the system.
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1710
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Fixed issue where studies were not appearing under My IRB Studies in Awaiting Action state.
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1758
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Added workflow for continuing participants during lapse in approval to New Study workflow in all states to accommodate lapses in approval related to Conversion studies.
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1793
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Fixed issue where Expired studies do not correctly transition to Expired-Continuation in Progress state if a CR is in progress prior to expiration.
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1796
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Created new State Transition on Study project type where it goes from "Expired - Continuation in Progress" to "External IRB Review Accepted" based on the "last motion of the study"
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1850
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Fixed issue where in rare case committee assignment logic failed due to dependency on altered smartform question.
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1730, 1745, 1800
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Cleaned up Copy Study activity by clearing information that should not be copied to the new study.
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Issue
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Enhancements to Activities/Workflow Affecting IRB Staff and/or Committee Members/Reviewers
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1732
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Fixed issue where motions were missing on Continuing Review Response Review Completed and Submit Response Review Findings activities.
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1481, 1716
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Separated PAR Record Final Motion into a new activity so that it is consistent with the other project type workflows rather than being tied into Prepare Letter/Notice activity. This alleviated several related issues and is now consistent with the other workflows.
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1712
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Added continuation of participants activity for all states of Study workflow to accommodate Conversion studies (lapsed IRB approval).
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1406
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Added functionality to default Show on Agenda to Yes for committee member conflicts of interest (name only). Caution: there is one situation that is still not automated: if project is already on meeting agenda before committee member alters conflict of interest form to indicate a new conflict with the study, then the name will not be triggered to be added to the agenda for that study.
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1703
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Added Response Due By field in Response Review Completed activity to mirror Finalize Designated Review.
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1762
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Fixed permissions issue on Return to IRB Staff Review activity so that it is available only to IRB Staff and in all needed states.
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1678
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Added code to change Modified Study committee to match Amendment committee any time Amendment committee is altered. Purpose was to keep committee member permissions in sync with assigned reviews.
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1718
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PAR: fixed issue with state transition from Designated Review to IRB Staff Review (for full committee studies).
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1789
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Amendment Expedited Review Regulatory Categories were combined into one for the Reviewer Submit Expedited Review and IRB Staff Expedited Review Completed activities.
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1709
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Fixed missing Assign Owner activity in certain points in the workflow.
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1763
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Fixed PI Assurances Typographical error
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1699
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Fixed Edit Acknowledgement activity for PARs and made available to IRB Staff for use.
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1715
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Fixed issue where PARs were not transitioning to Awaiting Action state on certain SSE motions.
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1436
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Set Approval and Expiration Dates activity now always updates the proper dates to the Finalize Consent Forms and Recruitment Materials activity.
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1695
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Updated Committee Member Inbox and My Completed Reviews tabs to fix issue where PARs were sometimes appearing in error.
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1747
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Cleaned up some outstanding references to NHSR with UCLA IRB Review Not Required.
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1662
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Removed Committee Member Attendance feature from the Meeting project, so that attendance for meetings is typed in manually. A long-term fix for the real-time updates to existing meetings for attendance will be coming in a future release.
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Issue
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Administrative Changes
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1353, 1700, 1711, 1833, 1834
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Permissions/activities were altered for site managers to be able to properly track activities and aid investigators with form errors.
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1734
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Made Copied From IRB Number available in Administration activity for studies that were created by making a copy of an existing study. This is a first step toward an eventual better solution to the issue of not having this information readily available to IRB Staff.
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1422
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Created new Dept. Admin. role that allows users with this role to see all projects that are in the department(s) defined for them, (and sub-departments in the EDB hierarchy) in a read-only capacity.
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1772, 1774
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Updated Issues Tracking system to aid base software upgrade process and future enhancements.
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Issue ID
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Changes to webIRB Application Smartform
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1589, 1461, 1523, 1663, 1554, 1562, 1606, 1643, 1658, 1607, 1582, 1681, 1565, 1608, 1595, 1576, 1549, 1510, 1650, 1570, 1629, 1566, 1527, 1561, 1563, 1630, 1580, 1647, 1520, 1600, 1644, 1385, 1659, 1642, 1584, 1525, 1617, 1646, 1457, 1573, 1620, 1544, 1402, 1577, 1656, 1664, 1588, 1614, 1645, 1490, 1605, 1535, 1611, 1538, 1661, 1522, 1667
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Added guidance, updated validation rules, revised question text and possible answers for clarity, fixed typographical errors, edited branching to accommodate additional types of studies.
Note: Studies in process or being Amended will require answers to newly added questions.
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Issue ID
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Changes to Other Smartforms
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1586, 1519
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PAR: Major overhaul of the Post-Approval Report smartform with altered questions and updated branching logic.
Note: PARs in progress will require answers to newly added questions.
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1543, 1409, 1500, 1666
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Amendment:
1. Added the entire PAR Smartform and branching into the Amendment smartform so that study team members can report PARs as part of an amendment.
2. Revisions to sections 1, 2, 8 and 9 including removal of unnecessary questions, altering of existing questions, addition of new questions, and updated branching logic to accommodate.
Note: Amendments in progress will require answers to newly added questions.
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Issue
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Changes to Email Notifications and Letters
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1372
1396
1503
1540
1463
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Study Team Reminders:
1. The Item in State too Long reminder is now set to only be sent weekly after 30 days from the due date, rather than daily. Only one 30-day extension to respond is allowed.
2. Enhanced Study Team Log Comments activity to send email notifications to member(s) of the study team selected by the person executing the activity.
3. Added email notifications to Study Team for all Submit Response activities.
4. Altered Send Training Reminder activity so that members of the study team can be selected to receive the notifications, and so that any member of the study team can execute the activity.
5. Added instructional text to the bottom of webIRB automated email notifications.
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1448
1470
1531
1622
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IRB Staff Reminders:
1. Confirmed IRB Staff receive email notifications when PAR reviews are completed by designated Committee Members.
2. Created email notification to IRB Staff when extension to respond is requested.
3. Added email notification to the Asst. Director and IRB Administrator for the committee when a member declines attendance to a meeting.
4. removed inactive user from notifications.
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1639
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Altered NHSR letters to reflect language UCLA IRB Review Not Required.
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1637, 1524, 1484, 1655, 1610, 1515, 1516
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Displayed additional information on all Notice templates (funding source name, grant number, funding type, other name if applicable, general conditions of approval, short title, attachments, etc.). Also separated conditions from determinations for 2 distinct lists.
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1335
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Posted IRB Letter regarding webIRB signatures on webIRB site in Other section of webIRB Home.
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1481
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Included IRB Requests on PAR letters
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Issue
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Changes to Activities/Workflow Affecting Study Teams
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1634
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Fixed issue where users cannot open new amendments if a previous amendment is in the state External IRB Review Accepted (ERA was not recognized as a Final state).
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1462
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Added a snapshot of the Study (modified study) when an Amendment moves to a final state (Approved, External IRB Review Accepted, Review Not Required, Certified Exempt).
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1410
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Fixed broken link to Originally Approved Version from study workspace.
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1502
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Added Faculty Sponsor Assurances and Send Notification for FS Assurances to additional states for Study and Continuing Review so that they can be completed in a more flexible timeframe.
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1615
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Added availability of Printer Friendly IRB Requests after study approval.
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Issue
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Enhancements to Activities/Workflow Affecting Committee Members/Reviewers
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1528
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Fixed Committee Member Inboxes so that only studies that are assigned to the committee member appear in the Inbox.
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1591
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Added new tab to PAR workspace to show a link to the parent Study workspace, as well as a list of all approved documents in the parent study.
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1569
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Updated Attachments tab in study workspace to include a missing attachment question from the application.
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1471
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For amendments, changed the Number of Changes recorded in the History to reflect the number of changes made to the Modified Study (rather than the Amendment form).
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1604
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Added Single Subject Exception determinations to Reviewer activities for documentation of Post Approval Report reviews.
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1602
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On the Amendment workspace, a new tab was added that displays the attachments that were changed or newly added as part of the amendment (on the Modified Study).
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1464
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Removed unnecessary Original Version reviews from Committee Member Completed Reviews tab.
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1612
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Fixed issue where resubmitted PARs were not appearing properly in the designated reviewer's Inbox.
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1564
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Fixed issues with Printer Friendly Reviewer Notes permissions for committee members.
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1389
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Fixed issue where studies and other projects were appearing in IRB Committee members' Inboxes even when the person was not a designated reviewer.
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1536
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Misconfiguration where Send Letter/Notice to Committee Member activity actually put the letter/notice in the Inbox for the committee member assigned as well as all the Chairs - this was fixed so that it now only puts the letter/notice in the Inbox of the member assigned in the activity.
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Issue
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Enhancements to Activities/Workflow Affecting IRB Staff
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1657
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Include Date Submitted in lists of studies throughout site such as Inbox
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1581
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Neonates Conditions were updated to reflect the regulations.
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1628
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When a study is copied, the documents/attachments that were added by IRB Staff as part of the Finalize/Stamping process are now removed on the new study.
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1619
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Fixed issue where Deferred studies were not always being displayed in the main New Protocols tab.
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1669
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Comments box was added to Send Letter/Notice to PI activity, comments are recorded in History.
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1436
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Instructions added to the Set Approval and Expiration Dates activity.
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1597
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Added updated link to OHRPP bill of rights to corresponding Conditions.
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1297
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Added new activity on all projects that allows IRB Staff to set a value for whether the project currently needs attention (by IRB Staff) or not, and to enter a brief note. Enhanced IRB Staff Inbox to separate between those that need attention and those that do not, and to display the brief note in the Inbox listing.
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1572
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Updated activities for IRB Staff to assign primary and designated reviewers so that they all work the same.
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1557
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Made available the Send Letter/Notice to Committee Member activity after it has already been sent for review, so that the reviewer can be changed.
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1472
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Altered IRB Staff tabs in My Home (NOT including Inbox) to show all projects in a given tab even if they are in the Study Team's court.
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1568
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Added Pre-Review Changes Requested activity for all In Review states to allow projects to be sent back to the study team at any point in the workflow.
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1532
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Created new ALL IRB STAFF INBOXES tab that is visible to all IRB Staff users in the My Home page. This tab shows the items in everyone's inbox, and can be filtered by Owner to show the inbox for a given IRB Staff individual.
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1596
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Fixed issue where IRB Staff were not able to edit one of the Conditions templates.
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1587
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Set Approval Period activity was re-named Set Approval and Expiration Dates.
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1551
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Added new activity for IRB Staff called Return to IRB Staff Review. This activity is available during In Review states so that study can be returned to the study team without conducting a review, and so that IRB Staff can call back a review from a reviewer.
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1618
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When a study gets the state Review Not Required, the review type will become RNR.
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1594
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Added IRB Staff Take Ownership and Reassign Owner activities to final states for Studies.
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1455
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New Activity was added in the In Review states for IRB Staff to send Request to Clarify Review to designated reviewers. No email notification is sent for this activity, but the discussion is logged to the History of the project for record.
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1493
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Removed unused activities for IRB Staff.
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1387
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Added missing attachment from study smartform to be available for IRB Staff to stamp on approval of the study.
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1638
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The project state NHSR (Not Human Subjects Research) was changed throughout the system to UCLA IRB Review Not Required (RNR).
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1517
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Included Comments in History of project when IRB Staff use the Reassign Owner activity.
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1541
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Workflow process to handle requests to continue participants during approval lapses was implemented for Continuing Review and Study. Request can be submitted by the study team within the CR smartform, or outside the system. IRB Staff can forward a request to committee member(s) for review from the CR smartform workspace or from the study workspace if there is no CR submitted for the parent study. Committee members can cument their decision using an activity, and then the IRB Staff can forward the decision back to the study team.
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1599
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Added additional error checking to accommodate taking projects off a meeting agenda to send back to Study Team for pre-review changes.
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1625
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Made Reassign Committee activity available on approved Studies for IRB Staff to allow reallocation of workload across committees.
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1395
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Added ability to edit final Notices for all projects (Study, Amendment, Continuing Review, Post-Approval Report) after they have been moved into their final states.
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Issue
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Changes to IRB Meeting/Minutes
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1529
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Paper agenda item Edit activity form was made to be consistent with electronic agenda item forms and information.
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1578
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Removed Committee Member titles from agendas.
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1550
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Agenda items are now ordered by IRB Number within each category.
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1673
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Fixed bug not allowing multiple sets of completed minutes to be added to upcoming agenda for ratification vote.
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1598
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Revised Finalize Meeting Decision activity (affecting minutes) to account for committee members who were out of the room during a vote.
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1585
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For expedited approvals appearing on the committee agendas, the Comments from Expedited Review Completed were removed from the agenda display, and the PI name was added, to be consistent with AAHRPP requirements.
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1579
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Upgraded Agenda Item notes to rich text in order to preserve formatting.
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1518
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Altered Minutes by adding template language, new field for Prepared By, and allowing editing of existing read-only fields when editing minutes.
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1682
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Fixed issue where Number Needed for Quorum was not saving for Committees.
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1603
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Made available the PAR determinations for paper PARs in the Minutes.
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1574
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Removed duplicative IRB # display in Agenda.
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Issue
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Administrative Changes
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1521
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Version Incrementing was re-configured in preparation for the upgrade to the newer version of the base software so that version comparison will work properly after the upgrade.
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1636
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Preparation activities for integration with Charles Drew University.
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1679, 1691, 1422
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New global read-only roles created for administration and tracking.
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Issue
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Changes to webIRB Application Smartform
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1178
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The Application Smartform was redesigned to match the AAHRPP accredited paper application forms. The changes include enhanced questions and new branching logic. A summary of the changes are listed below.
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1412
1485
1365
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Section 1.1:
1. Item 5.0:
â–ª Guidance added indicating that the person completing the submission must be listed on the first page of the application.
â–ª Changed the wording to indicate that both key personnel and study staff should be added to this item.
2. Added Guidance on how to use Select Fields to add study personnel
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1539
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Section 1.1a - Guidance:
1. Updated the information about when members of the research team must be identified by name,
2. Updated the link to HIPAA Training
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1404
1414
1482
1442
1473
1486
1407
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CRC – Continuing Review Sections:
1. CRC 1.1/item 2.0: This item was reworded and guidance added.
2. CRC 1.6: Added conditional validation to assure consistency of answers within the section
3. CRC 1.6/item5; Deleted this item since it duplicated Section CRC 2.5.
4. CRC 2.1: Added missing attachment field.
5. CRC 3.2/Item 2.0: Changed the wording from “administrative” to “Clarification or Technical Change.”
6. CRC 3.2/Item 5.1: Updated wording to clarify that only a summary of changes should be attached to this item; not the study documents.
7. CRC 4.0: Clarified wording
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1456
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Section 4.2/Item1: Fixed typo.
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1479
1507
1495
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Section 7
1. Branching/Items: The branching of this section and the conditional validations were enhanced.
2. Section 7.3/Item 1 - Non-UCLA Sites: The pop-up items and answers now appear in the printer version of the application.
3. Section 7.5: Typo fixed in the Note.
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1475
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Section 8:
1. Section 8.1/Item 1.0:Recordings (Audio or Visual) was changed to Audio, Visual or Digital recordings so that its order (alphabetical) would make it closer to the top of the list of Methods in section 8 of the Study application.
2. Section 8.10: Items in this section were modified.
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1397,1399,1424
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Section 9: The items/guidances throughout Section 9 were revised in accordance with AHHRPP standards.
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1430
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Section 19.3: Duplicative item for attachment of screening document was deleted.
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1476
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Section 20.1/Item 1.0: Added additional selection options
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1545
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Update Pop-Up Summary Views: Pop-up questions and answers are now displayed in the Printer Version of the study application.
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Changes to PAR Smartform
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1441
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Section 1.0/Item 3.0: Deleted unnecessary guidance in Post Approval Report form.
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Changes to E-mail Notifications
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1372
1492
1408
1491
1453
1514
1392
1439
1305
1423
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1. Item in State Too Long: Distribution and Timing: Enhanced Item in State too Long reminder email notification to be sent only weekly (rather than daily) and only to the PI, Proxies, Faculty Sponsor and Contact Person (rather than the entire study team).
2. Notice needed for Tabled Studies/Projects: An email notification was added to the PI, Proxies, Faculty Sponsors, and Study Contact, for studies that are Tabled.
3. Notice for Pre-review Changes: Altered language in Pre-review changes requested email notification to delete language that refers to Faculty Sponsor assurances, since FS assurances are no longer required on responses to the IRB.
4. E-mail Notice Recipients: Email notification recipient clean-up - added missing email notification recipients from a few study team email notifications.
5. PI Assurances Complete E-mail: Added email notification to IRB Staff owner when PI Assurances are complete on Study.
6. AM Reassign Owner Email Notification: Fixed issue where incorrect Owner was being used in Reassign Owner email notification to IRB Staff.
7. IRB Staff Agenda E-Mail:IRB Staff were added to the email notification that goes out when the Agenda is sent out for a meeting.
8. Notifications (Assigned to Committee): Removed email notification to study team when study is assigned to Committee, added email notification when study is assigned to Meeting.
9. Email notification for FS Assurances: Email notification was added when Faculty Sponsor Assurances are completed, and is sent to PI and PI Proxies.
10. Meeting Notification: Altered meeting agenda notification to IRB Members to remove unnecessary language and add a reminder to confirm or decline attendance.
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Changes to Activities/Workflow
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1416
1419
1429
1480
1403
1469
1435
1411
1428
1389/1528
1536
1505
1433
1421
1405
1534
1410
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1. Send Letter to PI Activity: Deleted language referring to non-existent activity.
2. Attach Documents to Activity Forms: Added an attachment field to the Refer to Designated Reviewer activity so that designated reviewers can be sent files as part of the review.
3. Removed “Send to Senior Staff’ Activity: since there is no distinction within webIRB between roles IRB Staff and Senior Staff, the Send to Senior Staff activity was removed.
4. Study Team Private Comment: Ensured that IRB Staff cannot view Study Team Log Private Comment activity in History of projects.
5. Send Ready Notification: Send Ready Notification activity now runs the Study Application validation checks before executing, similar to the checks on Submit.
6. PAR: Submit Designated Review Activity Form: Post Approval Report form was updated so that Adverse Events header reads Adverse Events and Updated Safety Information.
7. Instructions to Reviewer: Altered instructions to reviewer in study workspaces to be more applicable to the review process for committee members.
8. Withdraw Activity: Deleted “Error During Submission” as an option for Withdrawal, and added guidance.
9. Consistency on Pre-Review Changes Requested Activity: Workflow cleanup - renamed Pre-Review Changes Requested activity to be identical in all project types.
10. Unassigned Study in Member Inbox: Fixed issue where studies were appearing in IRB Committee members' Inboxes even when the person was not a designated reviewer.
11. Unassigned Notices & Letters to Review in Member Inbox: Fixed issue where letters and notices were appearing in IRB Committee members' Inboxes even when the person was not a designated reviewer
12. Meeting Minutes - Attachment of paper Minutes: Added report of expedited items field for paper items in Agenda, updated titles.
13. Edit Consent Forms and Recruitment Materials Activity: Warning was added to Edit Consent Forms Recruitment Materials activity to help IRB Staff avoid deleting attached files from the Study application.
14. General Conditions of Approval: Removed security certificate on linked page for General Conditions of Approval (from letters).
15. Meeting Agenda: Agendas must be closed manually now just prior to the meeting - the auto-close feature was disabled to allow last-minute agenda additions as needed.
16. Update Attachments Tab: Enhanced Attachments tab of study workspace to include all new attachment fields.
17. Original Approved Version Workspace: Fixed broken link to Originally Approved Version from study workspace.
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|
IRB Requests
|
|
1468
1351
|
1. Reviewer Notes: Enhanced IRB Requests for Pre-Review Changes Requested to show all notes to all IRB Staff users, regardless of who is the author.
2. Consolidated View/Printable Reviewer Comments: Created new printable views for IRB Requests for IRB Staff, Committee Members and Study Team. Each user can print ALL requests or MY requests (those authored by the individual). There are new buttons on the left side of the workspace for each option.
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Administrative Changes
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|
1511
1509
1273
|
1. Administration Activity Comments for all project type: Administration activity includes comments field on all project types for audit history in the rare case it is needed.
2. Display user's status from EDB: Added employee status from EDB to account information for site administrators to troubleshoot account activity issues.
3. Reference to Non-Existent Projects: Clean-up of Reporting Data
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|
|
|
Issue
|
Changes to Functions used by Study Teams and/or
to the webIRB Application/Help Text
|
|
1287
1373
1379
|
Application & Branching Changes:
- NCI CIRB Studies: A new page and branching logic was added to the study smartform for NCI CIRB reviewed studies. This will allow the study team to report all of the needed information for these studies.
- NHSR Studies: The branching will end at section 25, instead of section 100. This change was made to eliminate the confusion of having different instructions on each page.
- Study Locations: Correction was made to branching in Section 7.1
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|
1355
1357
1328
|
Typos:
- Corrected the spelling of “Funding Source” on attachments tab.
- Typos were corrected in Section 8.10 (MRSC) and Section 5.2 (Deleted the phrase “or behavior.”)
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|
1315
|
Send Notification to Faculty Sponsor for Assurances: Updated all study templates History tab to include "Send Notification to FS for FS Assurances" (it was missing in a few states) so that FS will now receive the notification and the activity will be seen by study staff.
|
|
1364
|
HIPAA Expiration Date – Profile and Training Tab: Wording was changed to HIPAA Completion Date
|
|
1318
|
PAR Smartform: Altered Smartform so that study teams can use it to report sponsor clarifications that do not require an amendment.
|
|
1350
|
Project Snapshot Dates: On Project Snapshot, the header information now indicates the time the snapshot was taken (it was previously using the information at the time the snapshot was viewed).
|
|
1303
|
Study Withdraw Activity Form: Removed non-applicable archival wording from Withdrawn activity form.
|
|
1324
|
Faculty Sponsor Assurances: Faculty Sponsor Assurances functionality was altered such that when the FS is changed on an approved study, the FS Assurances will become Pending in the study workspace until the NEW FS provides his/her assurances. Any time the Submit Amendment activity is executed, the system will check to make sure that FS Assurances are not Pending before allowing submission of the amendment.
|
|
1278
|
Study Team Comments to Each Other – Log Private Comment: Study Team members have the ability to write comments and add attachments to the History log through this activity. The comments can only be seen by study team members.
|
|
|
Changes to Function used by Committee Members, IRB Staff or Research Administration
|
|
1353
|
Return Study to Reviewer: Workflow was altered such that items can be returned to reviewers for additional review after the initial review has taken place but before sending the decision out to the PI.
|
|
1371
|
Programming of Approval Date: Approval and Expiration dates can actually be set by IRB staff and by the system using defaulting mechanisms well in advance of the official state change to Approved. Therefore new attributes and code were added to capture the actual official approval and expiration dates at the time of Approval.
|
|
1272
|
OHRPP Metrics: New attributes were added for data capture for internal OHRPP metrics.
|
|
1355
|
Default Period for Exempt Studies: Default expiration date was set to be 5 years for Exempt review studies.
|
|
1342
|
IRB Staff Reminders: IRB Staff will receive e-mail reminders if an item is in their inbox with out action for 14 days. The Assistant Director will also receive an e-mail.
|
|
1338
|
Pre-Review Changes Requested Activity: This function was added to additional states so that the IRB Staff can send submissions back to the Study Staff if additional information is needed for review.
|
|
1362
|
Meeting Agenda: Assigned designated reviewers are now appearing on the meeting agenda smartform.
|
|
1383
|
Application Snapshot Removed: Removed an unnecessary snapshot.
|
|
1250
|
Add Current Response Required Deadline date to Request Extension to Respond activity: Since Study's Request Extension to Respond activity has the Current Response Required Deadline date, it was also added on AM and CR.
|
|
1321
|
PAR Reviewer Screens: Review questions were added to the PAR Submit Review form for committee members to comply with AAHRPP standards and be consistent with the paper process.
|
|
1388
|
Update Discussion and Vote Screen: HTML tags were appearing for formatted text in the Update Discussion and Vote area of the Minutes - this was fixed
|
|
1394
|
Update Letter Templates to Display Modified Study Title rather than Approved Study Title: For all amendment letter and notice templates, as well as email notifications, the Modified Study title rather than the parent study (approved) title is now displayed.
|
|
1359
|
Reviewer Notes and Feedback Letters: IRB Requests were altered such that the current owner can modify existing requests and/or create new ones once a feedback letter is generated (even if that owner is not the same person who created the original request. If a note is modified by another person, however, the displayed owner will not change).
Also text boxes were added to Assign to Senior Staff, Reassign Owner, Send Letter/Notice to Senior Staff, Send Letter/Notice to Committee Member.
|
|
1348
|
NHSR Determination Letter: Replaced UCLA IRB with UCLA OHRPP language in NHSR determination letter templates.
|
|
1311
|
History Tab: "Sent Letter/Notice to PI." was added to the entry for when the letter is sent to the PI in the History log (there is already the motion (e.g., "approved") and a link to the letter).
|
|
1391
|
MIRB3 Smartform Agenda: The agenda smartform (edit Meeting Agenda) for MIRB3 was missing the section on the "Prepare/Confirm Meeting page" where IRB Staff can be added - this was corrected
|
|
1323
|
Review Screens – Route or Record Decision: This screen was renamed “Response Review Completed.”
|
|
1306
|
PI Assurances: A stop was added to the Send Letter/Notice to PI activity such that if the motion is final (Approve, NHSR, Exempt, External IRB Review Accepted) then the letter cannot be sent unless the PI Assurances are completed
|
|
1345
|
IRB Committee Member Notifications: Removed email notifications to assigned committee member reviewers on a per-item basis for Full Committee items, so that reviewers will only be notified at the time the agenda is sent out (in order to avoid confusion in the event that items are re-assigned prior to the meeting).
|
|
1301
|
Exemption Letter: Wording related to amendments was added to Exempt Certification notice
|
|
1380
|
Modified Study ID#: The format was changed so that it would be less confusing during the Amendment process.
|
|
1376
|
Send Letter or Notice to Committee Member: An attachment filed was added to the Send Letter/Notice to Committee Member.
|
|
1360
|
Expedited Review Categories for New Study: Expedited review categories were added to the Submit Expedited Review activity for Committee Members to indicate the applicable category(ies).
|
|
|
Changes to Functions used by Site Administrators/Reports
|
|
1375
|
FS Assurances in History Tab: Send Notification to FS for FS Assurances activity was edited so that the Site Manager can see the event in the History.
|
|
1393
|
Issues Log Enhancement – Deployment Testing: Workflow changes to enhance the Development tracking for issues resolution.
|
|
1384
|
OHRPP Metrics – Add Review Date: New attributes were added to capture data for internal OHRPP metrics.
|
|
|
|
Issue
|
Changes to Functions used by Study Teams and/or to the webIRB Application/Help Text
|
|
1129
|
FAQs are now only available on the webIRB Homepage under the following tab: “webIRB Frequently Asked Questions.” This allows for more frequent updates.
|
|
1224
1320
1271
1264
|
1. Help Text was added to the following application sections
a. 1.1 (Study Title and Key Personnel) and 1.2 (Conflict of Interest Info)
b. 8.1/Item 1
c. 10.1/Item 4 (Drugs and Biologics)
d. CRC2.1 and CRC 2.4 (Continuing Review)
2. Guidance added to CRC sections 2.1 and 2.4.
|
|
1225
1271
1326
|
Profile:
1. Typo corrected: “HIPPA” was changed to “HIPAA.”
2. Wording modified to indicate that HIPAA certifications do not expire.
3. The following statement was added to the first page of the Investigator/Study Personnel Profile:
Conditions of Use of webIRB:To meet regulatory requirements, passwords used to access webIRB must not be shared with anyone. All actions taken in webIRB are logged and include the individual performing the action, and the date and time that it occurred. Individuals are accountable for actions initiated under their user account.
Please indicate below that you understand and agree to comply with the conditions of use of webIRB as described above.
|
|
1336
|
Copy Study: The following sentence is now in bold red to make it more noticeable to study staff when they copy a study, “All attachments will be copied as well.” The webIRB team is working on a way to strip the attachments when a study is copied.
|
|
1334
|
PI Assurances: The PI Assurances are now more readily available to the PI once the study is submitted.
|
|
1330
|
Research Portal: webIRB data and links are now integrated with the Research Portal.
|
|
1254
1285
|
Training Log: Documentation added to the profile (e.g., training documentation, CV’s) is also displayed under the Training Log tab in the Study Workspace. The information is now accessible to all members to the study team for review/printing.
|
|
1307
|
Printer Version of the Application: Section Headers are now consistently displayed.
|
|
|
Changes to Functions used by Committee Members, IRB Staff or Research Administration
|
|
951
1239
1292
1302
1312
1243
|
Letters/Notices:
1. Templates aremodified to provide more accurate and formatted display of: Committee Member Names, Date, Last Motion, Agenda Item Notes, Approval and Expiration Dates.
2. Redundant fields and inconsistent data are removed.
3. The newOHRPP logo is now on all IRB correspondence.
4. Exempt Notices now have the term “Exempt” instead of “Approved.”
5. Typos fixed in New Study Approval Notice.
6. The Approval Notices now display the protocol version date/number from Section 1.1/item 1.1.
7. Display in blue box now correctly displays motion.
|
|
1056
1215
1280
1286
1290
|
IRB Requests:
1. Will be automatically added to the minutes at the time the letter/notice is sent to the study team.
2. IRB Requests are now available to IRB Staff to create/edit in all states until the letter is sent to the PI/study team.
3. Reviewer Notes are now available to Committee Members in all review states prior to the letter/notice being sent to the PI/Study Team. Also attachments fields were added to the Submit Review activity.
4. The Reviewer Notes now sort to match the order of the smartform pages under the Reviewer Notes tab and in the Letters.
5. Fixed permission settings for views of PAR reviewer notes.
|
|
1089
|
Activity Screens: The Submit Review screens (for IRB Reviewers) and Review Completed screens (for IRB Staff) are now more consistent in format and wording.
|
|
1102
|
IRB Meetings: IRB Members can now Confirm or Decline attendance for an IRB Meeting.
|
|
1158
|
Approval/Certification Periods: On Committee Member screen, set modifiable default periods to be one year for Expedited/Full Committee Studies and 5 years for Exempt studies.
|
|
1176
|
Grants & Contracts Administration: Read only access to webIRB is available to personnel in the following areas: OCGA, OIP, and CTCU.
|
|
1204
|
PAR Response Reminders: Automatic e-mail reminders will be sent to the study team when their response is past due.
|
|
1202
1222
1284
|
Meeting Workspace:
1. Added list of Designated Reviewers
2. Links to paper agenda items fixed.
|
|
1210
|
Meeting Agenda (Print Version): Fixed the link to the paper agenda items.
|
|
1253
|
PI & FS Assurances: The following changes were made:
1. PI Assurances are only required after initial submission of the study and after initial submission of each continuing review.
2. FS Assurances are only required before initial submission of the study and before initial submission of each continuing review.
3. The activity form checkboxes asking staff if FS Assurances are needed again has been removed.
|
|
1226
1288
|
Meeting Correspondence: Updated letter templates for correspondence from IRB Staff.
|
|
1229
|
Researcher’s Profile: IRB Members and Staff can now access all study team profiles for review purposes.
|
|
1233
|
IRB Staff Inboxes:
1. The New Protocols/Amendments/CR/PAR tabs on the My Home page now only display submissions to the staff’s assigned IRB(s). All submissions are viewable from the IRB Protocols tab.
2. PARs only display in the My Home tabs after submission.
|
|
1251
1174
|
Parent Study State: The review state of the parent study is now displayed on the Amendment Workspace in addition to the CR workspace.
|
|
1266
|
Administrative Actions: Administrative actions can now be seen in the History by the IRB Staff.
|
|
1267
|
Meeting Minutes: Format modified per OHRPP specifications.
|
|
1277
|
Approved Documents: External Review Accepted Notices now have links to approved documents.
|
|
1279
1313
|
Prepare Letter/Notice Screen:
1. The review and expiration dates were removed from the blue box as they were not accurate as configured.
2. Warning added to remind IRB Staff to ensure that the PI Assurances need to be completed before the approval/certification notice is sent out.
|
|
1295
|
Expedited Review Completed Activity Screen: Expedite Categories 8 & 9 added to accommodate CRs of conversion studies.
|
|
1300
|
IRB Staff Notification when IRB Member Completes Review: IRB Staff will receive an e-mail notification when Committee Members complete all types of reviews (FB, Expedited, Exempt, Correspondence and Response).
|
|
1337
|
Manage Conditions: Execution of the activity is now logged to History.
|
|
|
Technical & Changes to Functions Used by Site Administrators/Reports
|
|
1192
|
PAR: Fixed issue that prohibited new PARs from being created after a Copy was made of a PAR.
|
|
1325
|
CR: Fixed issue with CR count resetting and made the ID numbering consistent.
|
|
1322
|
Duplicate Account: The Key Personnel Field was modified so that only users with the Study Staff role can be added.
|
|
1293
|
Release Notes: Administrative tracking and enhancements.
|
|
|
|
Issue
|
Changes to webIRB Application or Help Text
|
|
1224
|
1. Help text items were added to the following sections/items: Study Application section 1.1/item 5 and Study Application Section 1.2/Item 1.1.
2. Typo fixed in Account Profile Section (“HIPAA” is now displayed correctly).
|
|
1242
|
Pull Down Menu for Countries: Study Application Section 7.4/item 2: The list of countries ended at “S”. This was fixed so that the list of countries is now complete.
|
|
1248
|
Jump-To Menu: The Jump-to menu was displaying sections that were not necessarily required by the study. This has now been fixed. Only the correct sections are displayed. As a result of the fix, the pages displayed on the Jump To menu no longer have section headers.
|
|
1260
|
Send Inquiry or Reply to IRB: When the study team use this function, the activity is now recorded to their History Tab.
|
|
1268
|
Study Application Section CRC1.4/Item 1.3 (NCI): Attachment of recruitment documents is no longer a required field.
|
|
1270
|
Study Application Section 18.10/item 1 (recruitment from Research Participant Pools/Recruitment Databases): An attachment field was added to allow for uploading recruitment documents.
|
|
|
Changes to Functions used by Committee Members and/or IRB Staff
|
|
1195
|
Stamped Documents: Stamped documents are automatically populated into continuing review notices (the stamped documents were already auto-populated on the study and amendment notices).
|
|
1196
|
Conditions of Approval: Conditions of approval will be auto-populated on post-approval report and amendment notices (This was already occurring for study and continuing review notices).
|
|
1202
|
Paper Agenda Categories: The categories for paper agenda items are now consistent with those for the electronic agenda items.
|
|
1209
|
Exempt Expiration Period: On the Committee Member Submit Exempt Review Activity screen, the certification period wording was changed from 3 years to 5 years to reflect the corresponding change in policy. Important Note: Click Commerce will be updating the default period on the Set Certification Date screen in April. Until that is done, the time period will need to be corrected by staff.
|
|
1211
|
Committee Member Upcoming Meeting Tab: Unneeded display of submission items listed under this tab was removed.
|
|
1222
|
Meeting Agenda View: The view of the meeting agenda that is generated when the Meeting Agenda button is clicked – now sorts appropriately by category.
|
|
1230
|
Researcher’s Profile: Committee Members now have access to the Researcher’s Profiles (top menu bar).
|
|
1252
|
Attachment Fields on Activity Forms: Attachment fields were added to the following activity forms to allow IRB staff to send annotated documents to study teams: Prepare Letter or Notice, Pre-review changes requested, Send Letter or Notice to PI .
|
|
1256
|
Typo Fixed: On the Exempt Reviewer Screen “Additional” is now spelled correctly.
|
|
1259
|
Send Letter/Notice to Committee Member: This function was fixed so that the letter/notice will only go to the specified Committee Member for review.
|
|
1262 &
1296
|
Send Inquiry or Reply to IRB: Previously IRB staff were not receiving the send inquiries or replies e-mails from the study team. This has now been fixed.
|
|
1263
|
E-Mail Reply to Correspondence to the IRB: Formatting fixed so that the header and footer display properly.
|
|
1276
|
Links to Departments/Divisions: These links were disabled because they were not editable.
|
|
|
Changes to Functions used by Site Administrators/Reports
|
|
1247
|
Enhancements were made to issue tracking
|
|
1272
|
OHRPP Metrics: New attribute added for data collection: DateFirstAction
|
|
1282
|
Converted Studies Report: A report of webIRB studies that are conversions from paper
|
|
|
ID
|
Changes to webIRB Application Wording
|
|
1225
|
1. Smartform Application - Section 8.1/Item 1/9th check box: The wording was changed from:
“Equipment used with UCLA hospital patients or….”
to
“Non-FDA equipment used with UCLA hospital patients or…”
2. The hyperlink help text for this item was updated to read: “Clinical Engineering performs safety and performance inspections of non-FDA approved equipment that is under review by IRB and is intended to be used in an area that is operating under the hospital’s license. Please contact Clinical Engineering at 310- 267-9000 if you have any questions.”
|
|
|
Changes to Functions used/seen by PIs and Study Staff
|
|
1227
|
Modified the “PI Suspend” activity so that the only members of the study team that can suspend a study are the PIs and PI Proxies.
|
|
1235
|
When studies are in pre-submission and the following activities are used, entries will appear in the History tab: “Withdraw” and “Reactivate.”
|
|
|
Changes to Functions used by IRB Staff
|
|
819
|
1. Committee Workspace:
- The “In Process” Meetings are now listed before the “Upcoming Meetings.”
- Removed link to “Last Correspondence Letter.” It did not belong in this area.
2. Meeting workspace: The links to people’s names have been changed from linking to an e-mail to linking to their profile (Note: additional feedback has been received on this item for possible future changes).
|
|
1203
|
View SYS_ Agenda Screen: “Principle” was corrected to read “Principal.”
|
|
1219
|
The following activities will now show up in the IRB Staff History tab for studies that are certified exempt: Finalize Consent Forms and Recruitment Materials.
|
|
1221
|
Added Attachment field to the "Send Out Agenda" activity.
Fixed the text box on the “Send out Agenda” activity so that the “additional notes/comments” added by IRB staff will be included in the e-mail generated by the activity.
|
|
1234
|
Added attachment fields to the following activities
- Pre-Review Changes Requested
- Send Letter or Notice to PI
- Send Inquiry of Reply to Study Team
All attachments and comments will appear in the history log for these activities.
|
|
1237
|
Created function to allow paper agenda items to be sorted by project type and within type, by Name (title).
|
|
|
