Release Notes Version 3.0

Refer to Release Notes Version 3.0.1 for additional system updates.

Released April 13, 2013

The following changes apply to Study Teams:

The "Add Appointment" button in section 1.4 of the study application has been removed. If you need to add an appointment that is not visible for selection, contact the ITS Service Center (4-HELP).

The PRC Summary Report will now display the Peer Review Organization selection(s) made in section 1-2.6.1 of the study application, in addition to any text entered in the free-form text field.

In section 1-6.6 of the study application, the "Bone Marrow Transplant" and "Leukemia/Lymphoma/Myeloma" options have been replaced with a new program option: "Hematologic Malignancies-Bone Marrow Transplant."

Minor revision to question 10-1.2 in study application.

Updated list of UM facilities in section 14.1 of study application.

"7000 Accounts" has been changed to "Research Medical Record Number" in section 14-1 of study application.

Nurse Practitioner/Physician Assistant services are no longer offered at MCRU and this option has been removed from section 42.1.2.4 of the study application.

The Investigational Drug Service (IDS) will now be reviewing all studies with a drug as the object of the study. Previously, only studies selecting "UMHS IDS" and "UMHS IDS Waiver" in section 15.1 of the study application were routed to IDS for review. Now, current and new studies selecting "Other" will also be routed to IDS. IDS will review to determine medication safety, proper drug management, feasibility of conducting the study at UMHS, and if MiChart Order Sets need to be created.

When responding "Yes" to Question 7-1.7 of the study application, a note displays alerting study teams to allow sufficient time for the MiChart Order Set to be created before starting the study. 

Various updates to questions on the IBC registration.

Updated the HIPAA and PHI links in section 13.2.6 of AE/ORIO.

MCRU Budget template and corresponding link have been updated. The link now directs users to the MCRU website where they can download the most recent budget template under the "Quick Links" column.

A list of reason categories is now available when indicating that a Scheduled Continuing Review (SCR) is for termination.

A column has been added to the Inbox tab, AE/ORIO tab, and In Progress tab on the parent application, indicating whether an AE/ORIO is an AE or an ORIO.

The "Notify Study Team Members to Accept Roles" activity has been enhanced. It now includes an option to select individuals that will receive an email notification once all study team members have accepted their roles.

New "Change Log" tab added to the Amendment workspace displays all changes made to the Amendment Coversheet.

 

The following changes apply to Core Staff and Committees:

A new expedited category, Umbrella Application, has been added.

For Amendments, an issue with the template display has been fixed.

Action item functionality has been updated. See the Manage Action Items help page for more information (also available in Core Staff section of Training page).

In the reviewer checklists of all studies and child submissions for which there is an open action item, "Action item is in effect" will display.

A bug when executing the Reassign Expedited Reviewer activity has been fixed.

"Publish Reviewer Checklist" activity is no longer available in Submission Review workspace.

The default sort order of the Core Committee Staff Inbox "My Reviews" list is now oldest to newest based on the date of the last state change of the submission review.

Studies that were changed to "Exempt Approved - Transitional" via an amendment will now display in the exempt reports.

An issue with the "Administrative Withdrawal" activity has been fixed. When Core Staff initiate the Administrative Withdrawal activity, all associated reviews will move to "withdrawn."

The Approved Study Summary for SCRs now displays performance site information.

IRB Staff and RDRC (and/or SHUR) will now be notified if changes are made to relevant sections of the application/amendment after RDRC and/or SHUR have issued their ancillary approval. RDRC and SHUR will receive an email notification and IRB Staff will have a reviewer checklist item, both of which indicate that changes have been made and may require re-review by RDRC and/or SHUR. If re-review is required, RDRC and/or SHUR will request that the IRB return the application/amendment for re-review.

A contingency will automatically be generated and added to the IRBMED Staff Reviewer checklist for all new studies sponsored by the Department of Defense.

 

The following changes apply to IRBMED Core Staff:

New "Hotlist" functionality added to Core Staff home workspace. See the Hotlist step-by-step for more information.

Updated "Exempt" and "Not Regulated" letter templates to include language about the Privacy Board.

 

The following changes apply to IRB-Dearborn:

Expiration dates are no longer included in the Consent Form watermarks.

 

The following changes apply to Ancillary Committees:

MCRU Approval Letter has been updated.

IRB Staff and RDRC (and/or SHUR) will now be notified if changes are made to relevant sections of the application/amendment after RDRC and/or SHUR have issued their ancillary approval. RDRC and SHUR will receive an email notification and IRB Staff will have a reviewer checklist item, both of which indicate that changes have been made and may require re-review by RDRC and/or SHUR. If re-review is required, RDRC and/or SHUR will request that the IRB return the application/amendment for re-review.

Ancillary committees, with the exception of IDS, will be notified via email when a study has expired, and RDRC/SHUR will be notified via email when a study is 30 days from expiration.