Released April 14, 2014
The following changes apply to all user groups:
COI Updates & eRRM/M-Inform Integration! eResearch Regulatory Management has been updated to comply with current Conflict of Interest (COI) regulations.
COI Staff now have the ability to flag studies for COI review when it is believed that an institutional conflict may exist.
Study team members with a COI Management Plan will no longer be required to upload the plan into eRRM. A link to study team members’ management plans in M-Inform is now available in the application workspace and on the Documents tab.
When adding a study team member to a study (on a new study or via an amendment on an existing study), eRRM will now check for any changes to appointment details that have been made since the appointment was first entered in the system.
Individuals added to the Other People to Notify group on Posted Correspondence are now listed at the bottom of associated email notifications.
IRB staff and Study Teams will now receive email notifications on the date an action item is due. IRB staff also now have the ability to set up post-approval action items.
Email notifications sent from eRRM will now include the study ID in the subject line.
Broken links in application question 1-1.1 and approval letter templates have been fixed.
The following changes apply to Study Teams:
In accordance with changes to Federal conflict of interest regulations, study team members with financial interests of $5,000 or more must now disclose the interest in M-Inform. For more details, see the UMOR website.
The Accept Role, Submit Application, and Submit Amendment activities for UM affiliates have been updated to include the new COI screening question and includes a link/button to the study team member's home page in M-Inform.
An error preventing some study team members from receiving approval notice email notifications has been fixed.
The Study Team Members list in the application workspace has been enhanced for improved performance.
An error that would remove the “Not all study team members have accepted their role on the study” message in the application workspace, despite there being study team members who had not yet accepted their role, has been fixed.
Changes have been made to the Scheduled Continuing Review (SCR) form for applications where the application type is “Requesting Review by a Non-UM IRB.” Certain sections/questions will display depending on which IRB is reviewing the SCR.
An error causing some users to incorrectly receive an error message directing them to complete section 26 of the study application before submitting has been fixed.
An issue resulting in the display of incorrect error messages associated with answering question 1.6 on the Amendment Coversheet has been fixed.
When declaring external sponsors on an application in question 2.2.5, users can now search for PAFs by PI Name or PI uniqname.
The text for application questions 4-2.1 and 16.2.10 has been updated.
A new Submitted? column has been added to the Applications Expiring within 90 days or less list on the Approaching Expiration tab in the home workspace, which indicates whether or not an in-progress SCR has been submitted.
An error preventing the Is COI? column of the study team details table from updating as necessary when a non-UM affiliated study team member changes their answers to COI questions F1 - F4 has been fixed.
The following changes apply to Core Staff and Committees:
Assigned Secondary and Other Core Staff Owners will no longer get copied down to any child submissions on IRB-HSBS studies.
The Request Change or Clarification recommendation option has been removed from the Full Board reviewer checklist.
For Ceding applications, a “Disapprove” option is now available as both a Reviewer Recommendation and as an option when completing the Record Committee Decision activity.
A contingency will now automatically be generated for studies with a pending certificate of confidentiality.
The Member Details tab in the Committee Workspace has been enhanced for improved performance.
An issue preventing Core Staff from viewing an amendment when it is used to remove their committee from the study’s review cycle has been fixed.
PRC approval letters will now include the full study title.
The PRC "Approve with Contingencies" letter has been updated.
The following changes apply to IRB Flint and IRB Dearborn:
IRB Flint and IRB Dearborn now have the ability to issue two-year approvals.
The “Exemption 2a” exemption category is now available for studies reviewed by IRB Flint and IRB Dearborn.
The following changes apply to Ancillary Committees:
A error that sent notifications to Ancillary Committees about studies that were disapproved before the Ancillary Committee reviewed the application has been fixed.
The list of changes that require RDRC/SHUR review on amendments has been expanded.