Release Notes Version 1.8

Application Form Changes

Create New User functionality has been added to the Add Study Team member activity.

1-5.12 is a required question that is now marked with a red asterisk

2.2 and 2.3.1 Gynecologic Oncology Group is now included in the list of sponsors

10-1 The link to http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm now opens in a new window. The help file tied to the help icon with links to OM Part 7(IV).

11-4.2 Validation has been added to this question

14.1 Added the following to HUM_Procedure UM Facilities:
Transfusion and Apheresis Service
Blood Bank (Hematopoietic Progenitor Cell Laboratory)

14.9.1 and 14.9.2 page validation has been updated

21-1.1 The ability to delete study team members has been removed. Additionally, all references to deletions have been removed from the instruction text.

33.4 Validation has been added to not allow for higher than minimal risk for studies involving children

The link to Adverse Events guidance on the amendment cover sheet now opens in a new window

1-3.1 AE Follow-up validation has been fixed

3.1 A “no performance site” option has been added for emergency use studies

Amendment

The text "click on the Submission ID # to view the submission and all documents contained therein" has been removed from the AE Summary Report

The Last SCR total for Adult and Children is no longer overwritten by the amendendment

SCR

Section 1
Current Text: 
1-1 Study Risk Level
 The original risk level assigned to this study was:
 1-1.1 * Indicate the highest level of risks of harm to the subjects resulting from the remaining portion of this research?
Revised Text:
1-1 Study Risk Level
The original risk level assigned to this study was:
The risk level currently assigned to this study is:
The previously described potential benefits of this study are: (Note: If the benefit description displayed below does not accurately reflect current expectation, submit an amendment to update it.)
Direct Benefits:
Indirect Benefits:
1-1.1 Indicate the highest level of risks of harm to the subjects resulting from the remaining portion of this research. (Note: If you are changing the risk level from what was previously approved and you have an amendment open, be sure to change the risk level to match in the amendment.)
1-1.2 Based on study results to date, is the current risk-potential benefit assessment different from that previously described?
1-1.2.1 If yes, describe how it is different.

2-3 The calculation error has been fixed

Office 2007 files are now compatible

For Continuing Reviews, the submission summary button is now only available to committee members and core committee staff

A bug introduced in release 1.6.3 (Click 5.5.3) required completion of the detail page for radiation for all study team members, when only study team members involved with radiation need to complete it. This has been fixed.

When an amendment involving a change to the PI is approved it the PI owner field in the parent study workspace is now updated

Study team members with roles of staff, consultant or other will no longer receive PEERRS email notifications/contingencies

The Submit activity has been corrected to allow SCRs that have not answered application question 2.3 to be submitted

Reviewer checklist completion is not required when a reviewer requests changes

The reviewer checklist items have been updated to reflect changes in the application

The UAP reviewer checklist has been updated:
Question #2
Current Text: Is the event or information related to (caused by) the research?
Revised Text: Is the event or information related to the research? "Related" means there is a reasonable possibility that the event or information may have been caused by OR is linked in a significant way to the research. This encompasses all aspects of the research-it is not limited to events caused by research procedures or test agents. It is not necessarily limited to actions of the UM investigators.

Question #3
Current Text: Is the event or information unexpected in terms of the nature, severity, or frequency given (a) the research procedures that are described in the protocol-related documents and (b) the characteristics of the subject population being studied?
Revised Text: Is the event or information unexpected in terms of the nature, severity, or frequency given (a) the research procedures that are described in the protocol-related documents,(b) the characteristics of the subject population being studied, and (c) the subject’s predisposing risk factor profile for the event?

A potential UAP field has been added to the Single Member Review Report

Approval dates for each ancillary committee will now be recorded

A “last date modified” column has been added to the core staff's Inbox and In Progress tabs

The History Tab in all project workspaces for core staff now displays a Reviewer History listing reviewer checklists that meet the following criteria:
1) Are not staff checklists
2) Are checklists for the same committee group as the user who is looking at the screen
All reviewer checklists for the application plus all child submissions (amendment, continuing review, and adverse events) will display.
The reviews appear in chronological order by date created.

If the user answers YES to Question 10-1.2 (Will the subjects be audiotaped, videotaped, or photographed;  or will recognizable images of subjects  be recorded during the research?)
The following item will be added to the reviewer checklist: 
Confirm that any required informed consent document(s) and/or debriefing documents(s) seek explicit permission (e.g., separate signature) to record the subjects and/or use the materials for the purpose of this research. 

IRB-Behav Sci/Health Sci can now issue a 2 year approval applications that are NOT:  FDA regulated, federally funded, clinical interventions,using prisoners, or issued a Certificate of Confidentiality. This capability has been added to eResearch via a new approval period option and new approval letter templates. An error will be generated if staff attempt to record or issue a 2 year approval for a study that does not meet the criteria listed.

If a Cancer Center Program Director (CCPD) requests changes and the study team removes that CCPD, and he/she is the only CCPD who hasn't approved the study, then the study will now automatically move to Core Committee Staff Review instead of returning to Cancer Center Program Director Review.

The Edit Approval Period activity in application and amendment has been updated to reflect the date fields now in use in the workspaces

An error message on the Finalize Documents activity will state that the expiration date for a document must be filled out

The Finalize Documents activity will now allow for more documents (greater than 80) to be finalized

A complete list of documents from 10-1 will now display in the Finalize Documents activity

For all submission types except Adverse Event, if the submission is disapproved, the staff review moves to the state  Under Revision; If a PI executes the activity of Rebut Decision, the staff review moves to the state Review Study Team Changes; if PI executes the activity of Decline Right to Rebut, all associated reviews move to the state Finalized.

The Final Report activity will no longer set the IRB Final Outcome date.

The Super Admin user role now has an Administrative Rollback activity which allows them to rollback a study from an Approved state to a Validate Full Committe Decision, Validate Expedited Decison, or Core Committee Staff Contingency Review state.

The Review Types for Submissions and Amendments will now display.

2.3 Updated to: Are any of the above spaces shared by other faculty?  2.31-If YES, indicate which space is shared with whom.

3.1 added "Expected length of answer: between 200-300 words" to question note.

6-1 The table validation is fixed.  If a person chooses yes they are now required to put information in at least one area of the table.

9.4 the answer text no longer appears in bold font

Additional instructions have been added to the Amend Registration activity, which is used by a PI to begin the amendment process for IBC

The IBC office will now receive a notification when an amendment to a registration is submitted

The track changes functionality has been fixed to show all text instead of the underlying code numbers

The Expiration date on approved studies for IBC now show 3 years from date of initial approval instead of 3 years from last amendment

The system will no longer allow multiple registrations for one PI

The Reviewer Comment box now allows for an unlimited amount of characters