Release Notes Version 3.9

Released November 7, 2015

The following changes apply to All Users:

  • An editable subject line has been added to the Post Correspondence activity for applications, amendments, Continuing Reports (SCR) and Adverse Events (AE/ORIOs).
  • The Update NCT Number activity is now available on all HSBS studies.
  • Language in the COI question for UM Affiliates has been updated to read: “Your optioned/licensed invention  (e.g. intellectual property, such as a device, compound, drug, software, survey, evaluation or other instrument) is being used in this research.”

The following changes apply to Study Teams:

  • When an Adverse Event (AE) or Other Reportable Information or Occurrence (ORIO) is in progress, red text now displays in the application (HUM) workspace indicating AE/ORIO In Progress.
  • The ability to upload a document has been added to the following activities for:
    • Submit Changes Requested by Ancillary
    • Submit Changes to Core Staff
    • Submit Contingencies
  • An email notification is now sent to applicable Study Team members when:
    • Ancillary Committee Approval is given on an application or amendment.
    • Ancillary Committee determination on an amendment is No Review Required.
  • An error causing an incorrect page to display when the user clicks the icon beside the workspace message warning "Note: Not all required study team members have accepted their role on this study," has been fixed.
  • A broken link on the Accept Role activity for non-UM affiliates has been fixed.
  • The options available for selection in application question 38.1 (research involving prisoners) have been updated to remove the word “solely.”

The following changes apply to Core Committee Staff:

  • Other Core Staff Owners entered on a HUM application will now carry over to any "child submissions" of the application (e.g., AE/ORIO, Continuing Review, Amendment, Submission Review).
  • An error preventing submissions under Core Committee Staff Contingency Review from transitioning to the state of Not Regulated when applicable has been fixed.
  • The Application Umbrella approval letter template can now be selected in the Approve activity drop-down menu.
  • IRB-HSBS can now select from all reviewer roles (IRB Primary Reviewer, IRB Secondary Reviewer, IRB Scientific Reviewer, IRB Other Reviewer and Privacy Board Reviewer) when completing Full Committee Review and Expedited Review.
  • A new Return to CCPD Review activity is now available to PRC Staff on applications and amendments. This activity routes the submission back to PRC for review and changes the state of the submission to Cancer Center Program Director Review.
  • A Submitted Date column has been added to AE Summary Report and ORIO Summary Report tables.
  • An error causing meeting minutes entered via the Update Meeting Minutes activity to be deleted when an amendment is completed has been fixed.
  • When executing the Project Hold activity on a study, an error causing the associated Action Item to not include a Created Date has been fixed.
  • The Update MIAP Review Requirements activity in the application and amendment workspaces can now be executed on a submission at any time except for when an amendment is in progress and/or when MIAP Review is in progress but not yet complete.
    • This activity now also includes a required Comments field in the activity window.
  • Columns can now be sorted by clicking the column heading when viewing All Issues (IRB tab, Submit Review activity, etc.).
  • When a Repository Application review is submitted, the reviewer’s role and the date/time it was submitted now display in the application workspace.
  • Start Date and End Date now display when searching for PAFs.  Additional enhancements have been made to address reports of the PAF search timing out.
  • The following updates relate to the Repository Application:
    • Various text updates have been applied to approval letter templates.
    • Changes have been made to the text of auto-generated issues.
    • Issues are now sortable by clicking the column headings.
    • A Post Anonymous Correspondence activity is now available to Committee Reviewers.
    • An error occasionally causing the Approval Period to not display when approving after contingency review has been fixed.

The following changes apply to MIAP:

  • An error causing some approved studies to display on the Unassigned tab has been fixed.
  • An Edit MIAP Staff Notes activity is now available in the application and amendment workspaces.  Notes entered display in lists on the Inbox, Unassigned, Office and Previously Reviewed tabs, and they are visible only to MIAP users.
  • Submissions that are still undergoing PRC review will no longer display on any of the tabs in MIAP users’ home workspaces.
  • An error sometimes causing applications to unnecessarily be routed to MIAP for review has been fixed.

The following change applies to COI MED:

  • An error causing COI MED staff to receive email notifications for child submissions of studies they once reviewed, but no longer require COI MED review because of changes made to the application, has been fixed.

The following chage applies to MCRU:

  • A new Reviewer Checklist and other enhancments have been made to the MCRU review process. For additional details, see the following: