Release Notes Version 2.0

Released February 28, 2009

Initiatives (Refer to Release 2.0 changes for more details)

Customized Application Paths

There are new, shorter, application paths for Exempt, Not Regulated, Secondary Data Analysis, and Requesting Review by a Non-UM IRB application types. To use these paths select the appropriate application type in question 1-1.1. Application Type options will display according the IRB that is selected (for example, the Requesting Review by a Non-UM IRB type will not display for studies that are being submitted to IRBMED).

Non-Key Personnel Changes

Using the Edit Study Team Member activity, study teams will have the ability to update non-key personnel (study team members with roles of staff, consultant, or other) on approved applications without submitting an amendment.

Design and Usability Changes

The eResearch Regulatory Management system has a new look and additional functionality to make it easier to navigate throughout the application.

Workspace Changes

    • Study Team list can be expanded or collapsed
    • The tabs have moved up on the screen
    • MAIN tab displays study status, activities and correspondence (this is the same information displayed on the Correspondence tab prior to Release 2.0)
    • Activities are now links, icons have been removed

Form Changes

    • The question boxes have been reformatted.
    • Throughout much of the application, questions conditionally display based on how the study team responded to previous questions.
    • Help displays on right-hand side of the screen. You can choose to Hide the help.

Amendment Workflow Changes

In the current system, amendments must be processed through all of the committees that reviewed the original application, even if the changes are not relevant to that committee. After Release 2.0, non-IRB committees will only review changes that are relevant to them. Details...

Clinical Research Billing Unit (CRBU)

The CRBU Initial Review Form has been incorporated into section 14-1 of the human subjects application.

Additional Changes

Information on submissions that are in progress at the time of the release.

Expand/Collapse Application Form Changes

1-6.4 Clinical Trials Office resources question has been moved to 1-2.5.1.

8-2.1 New question: At what point in the study are you planning on beginning the recruitment of subjects?

13.3 New question: Estimate the maximum total payment (including cash, checks, gift cards, and other cash equivalent incentives) that an individual could receive for participating in this research in a calendar year.

Section 15 and 16: A pending checkbox has been added to questions requesting IND and IDE numbers.

Investigators who select college students in question 9-1.1 AND enter an age greater than 18 in 5.6 will no longer be routed to section 40. Additionally, the heading for section 40 has been changed from College Students to College Students (under 18).

There are new Conflict of Interest questions for health system employees.

Expand/Collapse AE/ORIO Form Changes

If an AE is changed to an ORIO (or vice versa), the "sub-type" will now automatically update and the validation rules for that sub-type will apply.

3.2.9 Is this event and/or the incidence, severity, and magnitude expected? If UM PI and oversight entity disagree about this assessment, explain in 3.3. The question has been updated to reference 3.3 instead of 2.4.

Expand/Collapse Amendment & SCR Form Changes

1.2 has been removed from the Amendment Cover Sheet.

The SCR enrollment table instructions have been revised.

Expand/Collapse Letters & Notification Changes

The SCR Approve with Contingencies letter has been revised.

Emergency Use studies will no longer be sent renewal reminders.

The Adverse Event receipt notification will display the IRB that has received the AE instead of the IRB committee.

The Not Regulated determination letter has been revised and a new Not Regulated self determination letter has been added.

Expand/Collapse PI & Study Team Process and Workspace Changes

Refer to the Initiatives at the top of this page.

Expand/Collapse Review Committee Process & Workspace Changes

On the Reviewer Checklist, the current status of the review has been moved to the top of the Submit Review page.

A statement appears on the Approval Period page of the Reviewer Checklist that states "By submitting this review, you are certifying that the research meets the regulatory criteria for approval contained in 45 CFR 46.111 and 21 CFR 50 and 56 - or will meet the criteria when contingencies are addressed."

Expand/Collapse Core Staff Process & Workspace Changes

A documents upload option has been added to the Add Previous Meeting Minutes activity.

A new activity, Add Approved Meeting Minutes, is now available which allows staff to associate approved minutes on the meeting workspace for the meeting which they were approved.

A text field has been added to the Mail Out Agenda activity. Text entered in the field will be included in the text of the email notification.

On the Committee Member Detail page, a list of declined meetings will now display.

The Manage Documents activity is now available on the SCR workspace.

The Finalize Documents activity now references the correct section for Recruitment Materials (8-2.7).

An auto-contingency will be created for IRB staff when study teams submit an application with the pending checkbox selected in section 15 & 16.

The Printer Friendly Version of the Amendment Cover Sheet has been removed.

Expand/Collapse Ancillary Committee Process & Workspace Changes

The PI name will now display on the ancillary committee workspace.

Expand/Collapse Institutional Biosafety Committee (IBC)

Section 4 has been updated.

Question 6-1.4.1 has been changed to: Are mutations in the gene(s) you are studying known to, or expected to, cause disease?

Question added to Section 8, 9, 10, and 11: Which gene(s) is(are) cloned on your [adenovirus/retrovirus, etc] vector?

Reminder notices will be sent to PIs who have a registration in a presubmission state for 30 and 60 days.

Interested party users will receive a notification when an IBC Registration is approved.

IBC staff will have the Assign Reviewer activity in all states.