Version 4.2

August 19, 2017

Human Subjects Application

  • The Last Continuing Review (SCR) Study Status now displays on the HUM Workspace.
  • Updates were made in 1-6.5 to reflect changes to the Cancer Center Research Programs names and organization.
  • The help text link in 12-3.2 for Materials Transfer Agreement was updated.
  • IRBMED’s ORIO guidance changes for 32-2.3: Changed reporting mechanism for IRB reports from "eResearch AE/ORIO submission" to "eResearch" and changed associated help text to: “See Other Reportable Information or Occurrence (ORIO) for guidance on how and when to submit monitoring reports.”
  • Routing to Section 16 was removed on IRB Flint Applications when question 7-2.1 is answered "Yes".
  • Help text now displays for section 42 - MCRU.
  • Updates were made to MCRU Sections 42.3, 42.4, and 42.4.1 to reflect business processes changes.
  • HIPAA questions were changed to allow non-UM PHI.

Amendments

  • A “Return to Amendment Workspace” link was added to the Amendment audit trail.
  • A staff reviewer checklist will generate for changes to the payment tier when it is recalculated.
  • Email notifications will now include submission titles for Amendments, AEs, and ORIOs.
  • Question 1.7 of the Amendment cover sheet was updated to be more inclusive of urgent amendments.

The following change applies to the HUM, AE, AME, and SCRs

  • The Post Correspondence activity now appends the submission ID and PI name to subject line for all project types.

the IBC Application

  • On the Post Correspondence activity, added options to select a recipient or to not send an email.
  • Section 3 question 3.7, Vector Types Used in Your Research added an option for MSCV backbone to the list.
  • Changed wording on sections 4-1.1 question 6 and 4-2.1, question 12
    • From “Detail question about biosafety containment level" To
  • “What is the appropriate biosafety containment level for work with this substance?”
  • Wording in section 6.1, question 3 was changed to: "Are any of these animals immunocompromised (e.g., either immunodeficient or immunosuppressed)?"
  • Naked rDNA/SNA administration details selected in question 7 will now populate the table in section 6-1.

the Repository Application

  • An issue where an amendment to a Repository Application was missing from the "Items To Process" tab in the Meeting Workspace has been fixed.
  • An issue was resolved on Amendments that would not allow the approval to complete when changing it to a "Data Only” Repository.
  • Notifications were improved to include the Repository Name and project link.
  • The expiration date was added to project listing components on Core Committee Staff Inbox and In Progress tabs and on the CR Workspace.

IRB staff

  • Staff can now upload documents when expediting submissions.
  • The last column under My Reviews of the Inbox replaced “Is Urgent” with “AE/ORIO”.
  • Staff notes in the Inbox will be populated with the highest risk level selected in question 6.5.
  • The Amendment Admin Approval Letter now has a “Supporting Documents” field.

MCRU

  • The "MCRU Nurse" role was renamed "MCRU Clinic.”
  • An issue was resolved so that studies terminated prior to completion of MCRU review will no longer show in the MCRU Reviewer’s Inbox.

MIAP

  • MIAP review functionality was implemented for Adverse Events and Continuing Reviews.
  • A new question was added in Section 7-2 to ensure that studies with radiopharmaceuticals fill in Section 15 and are routed to MIAP for review if there is an IND.
  • A bug was fixed so MIAP owners won’t receive notifications when MIAP determines Review Not Required.
  • An email notification was adjusted so that it is sent to ORCR upon completion of MIAP review.

ORCR Staff

  • A new role for ORCR was created which includes access to the Committee Workspace for a meeting (agenda, minutes, attachments, and comments).

PRC staff

  • Application and Amendment versions on the PRC Summary Report were adjusted.