Release Notes Version 2.2

Released November 15, 2009

Initiatives (Refer to Release 2.2 changes for more details)

Additional Changes

Expand/Collapse Application Form Changes

Engage updated to ENGAGE throughout the application

Conflict of Interest list on submit display reordered, "No known conflict at this time" now appears first

1-6.6 Programmatic Priority removed

10-3 and 10-4 smartform logic updated so it doesn't route for requests for waiver of Informed Assent for Children

14-1.1 CRBU: 4 questions combined into one and Help updated

32-1.1 – MCRU removed from the list of AE reporting options

Section 42 – updates to MCRU questions and updated budget template

Expand/Collapse AE/ORIO Changes

On the documents tab, section titles for the jump to links updated

The Printer Friendly Version now opens in a new window

Webridge error for create new AE/ORIO activity removed

Expand/Collapse Amendment & SCR Changes


When closing the Printer Friendly version, the user will return to the submission workspace

The Edit/View button is now dynamic on the button and coversheet

Additional routing issues resolved


Blank pages will no longer appear at the end of the Printer Friendly Version, and the PFV will open in a new window

In the submission summary, the link to section 11 now points to section 11

The history under the tabled activity was displaying a blank approval letter, this has been removed

Expand/Collapse Letters & Notification Changes

New SCR approval letter templates for IRBMED that contain the following text: The informed consent has been watermarked per IRBMED Guidance, which is available on the IRBMED website,  If this study is currently closed to subject accrual, an amendment may need to be submitted to change the study status and to revise the informed consent to the current template before subject recruitment may begin again.  Please feel free to contact IRBMED if you have questions.
Template names:
Editable_Continuing Report_Approve_Expedited_IRBMED Editable_Continuing Report_Approve_Full Committee_IRBMED

Expand/Collapse PI & Study Team Process and Workspace Changes

Links to Click Commerce Help removed

Co-Is and Faculty Advisors no longer have to accept their role on Not Regulated study applications

The accept role activity will now display after a study team member has been deleted and re-added to the study

Section 3-2, printer friendly version issue has been corrected

PEERRS feed updated

The Edit Study Team Member activity is available during terminations

In the terminated state, the application title was displaying twice – this has been corrected

Errors with the Withdraw and Admin Withdraw activities have been fixed

Current Reviewing Committee has been added to the state transition table for reporting purposes

Study Team member display selection continues through tabs on submission workspace

Expand/Collapse Review Committee Process & Workspace Changes

Inactive committee members will no longer receive notifications

Expand/Collapse Core Staff Process & Workspace Changes

Staff can edit risk level(s) selection for all new applications

The Exempt/Expedite report has been corrected

A new column, Review Last Modified date, will update when a reviewer submits their review

In full committee, if the reviewer selects "Request for change or clarification" the submission will move to the Core Committee Staff Review state

New SCR checklist item for expiration date on the COC (Certificate of Confidentiality)

An auto-contingency has been added for IND/IDE documentation and the language IND/IDE contingencies have been updated

Conflicted committed members will display when assigning a review, and an error will display when assigning a conflicted reviewer

The staff owner name will display on the parent application when it is changed on an amendment

Termination reports will no longer overwrite the risk level on the parent application

The default sort order for committee meetings is the meeting date, not the meeting name

Submissions assigned to the Privacy Board will appear on the IRB tab

The checklist item for informed consent has been updated so it is available to more types of reviewers


PRC summary report subject participation information updated


GCRC tab name is now MCRU

Expand/Collapse Ancillary Committee Process & Workspace Changes

Updating Conflict of Interest information in 1.3 will now properly route to COI ancillary review