Release Notes Version 1.5.4

March 23, 2007

Overview of Changes for Committee Members

Expand/Collapse Application Form Changes
  • Question 1.12 has been changed.
Old New
"Facilitated Review (DO NOT SELECT - UNDER CONSTRUCTION)
(DO NOT SELECT - UNDER CONSTRUCTION) ONLY for studies that have already been approved by the NIH NCI Central IRB."
"Facilitated Review
Use ONLY for studies to be conducted under joint oversight of the NIH NCI Central IRB (CIRB) and IRBMED. Click here for more information
"
The click here for more information text includes a link to a new help page.
  • Question 1-6.6: The answer to this question now contains a link that displays the name of the Cancer Center Program Director for that research program.
  • Question 15.3.11: The text has been changed.
Old New
FDA IND Documentation/Investigator's Brochure:

For an investigator-sponsored IND (an IND submitted to the FDA by a University investigator), submit a copy of the IND application and subsequent FDA correspondence, including any amendments.

For a manufacturer-sponsored IND, submit copies of the manufacturer's investigator's brochure or comparable document.
FDA IND Documentation/Investigator's Brochure:

For an investigator-sponsored IND (an IND submitted to the FDA by a University investigator), submit a copy of the IND application and subsequent FDA correspondence, including any amendments.

For a manufacturer-sponsored IND, submit copies of the manufacturer's investigator's brochure or comparable document.

Upload IND safety reports not included in the investigator's brochure.
  • Question 18.17: The validation rule for the selection of "Pathology Department Paraffin Archive" has been corrected.
  • Question 21-3: The help links for this question have been updated.
  • Question 25-1.3: The validation rule for this question has been corrected.
  • Question 25-4.3.1: The revision history link has been restored for documents uploaded in this section.
  • Question 32-1.6: The text has been changed.
Old New
"Affirm that the EXPECTEDNESS will be assigned for each adverse event according to the following definitions:

Unexpected adverse events (i.e., NOT included in the informed consent document)
Expected adverse events (i.e., included in the informed consent document)"

"Affirm that the EXPECTEDNESS will be assigned for each adverse event according to the following definitions:

Unexpected adverse events (i.e., has NOT been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other documentation)

Expected adverse events (i.e., has been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other documentation)"
Expand/Collapse AE/ORIO Form Changes
  • Question 4.2.6 incorrectly referenced question 3.4, it now references question 4.3.

  • When creating a new Adverse Event from the Exempt Approved - Transitional workspace, now launches the smartforms, instead of just the first page.
Expand/Collapse Reviewer Checklist Form Changes
  • The IRB Staff Reviewer Checklist has been enabled. In addition, a Staff Checklist item will be created for every section the PI completes (not just the sections that are required).
  • The Reviewer Checklist has been reformatted to provide more room for comments.
  • The General Issues for Study Team/Staff section has been renamed Additional Issues
  • The Reviewer Notes section has been renamed Notepad.
  • An IRB Facilitated Reviewer role has been added to the list or IRBMED reviewer roles.
  • Text regarding immediate involutary hold has been removed from checklist item 4.
  • The Reviewer Checklist item for question 8.1. incorrectly referenced question 8.3; this has been corrected.
  • The IRB Staff reviewer checklist items for section 25, HIPAA, were referencing the wrong subsections. This has been fixed.
Expand/Collapse SCR Form Changes
  • Section 2.0 in the Submission Summary now displays the snapshot of the AE Summary Report.
Expand/Collapse Letters & Notification Changes
  • Approval letter templates for Facilitated Review have been added to the system for Applications, Amendments, Continuing Reviews, and Adverse Events.
  • All Amendment, Continuing Review, and Adverse Event outcome letters now include the title of the submission.
  • The Protocol Review Committee (PRC) will no longer be copied on IRB outcome letter notifications.
  • The approval letter for Exempt Continuing Reviews was not displaying the entire text of the exemption category. This problem has been corrected.
  • The following text has been added to the continuing review approval letters, "In accordance with 45 CFR 46.111 and IRB practice, consent document(s) and process are considered as part of Continuing Review to ensure accuracy and completeness. The dates on the consent documents have been updated to reflect the date of Continuing Review approval."
  • The notice sent to the IRB staff indicating that a reviewer requests clarification on a continuing review now worrectly reports the state of the continuing review.
Expand/Collapse PI & Study Team Process & Workspace Changes
  • Revision history has been restored to the following areas:

    New Application Documents tab: - Shared supporting documents - Internal supporting documents - Historical documents New Application, Manage Documents activity form - IRB-approved documents - Shared supporting documents - Internal supporting documents - Historical documents New Application, Ancillary Manage documents activity form Reviewer checklist form, supporting documents

    Amendment Documents tab: - Supporting Documents uploaded by core staff Amendment, Manage Documents activity form - IRB-approved documents - supporting documents Amendment, Ancillary Manage documents activity form Meeting - Edit Discussion Items Activity Form - Workspace, Agenda Discussion Items detail page  

  • Documents uploaded in question 25-4.3.1 (Limited Data Set) and 38.8 (Prisoners) now display on the Documents tab.
  • For expired studies, a link to the system-generated expiration letter now displays on the Correspondence tab.
  • The text "In the study workspace, scroll down to Outstanding Issues to see a list of requested changes," now only appears in the study team Correspondence area, and in the notifications, if there are outstanding issues to display.
  • In Amendment and New Application, when changes or contingencies are requested, if a new co-investigator or faculty advisor is added and has not accepted their role, an error message will be displayed if the study team attempts to submit the changes or contingencies. Previously the study team would get an Internal Server Error instead of an error message instructing them to have the new co-investigator or faculty advisor accept their role.
  • Approved Adverse Events were unavailable for followup reporting if an Amendment was created and approved after the Adverse Event was approved. This problem was introduced with release 1.5, and has been corrected.
Expand/Collapse Review Committee Process & Workspace Changes
  • A Documents tab has been added to the Reviewer Checklist workspace. This tab contains the same documents that display under the Documents tab on the submission workspace.
Expand/Collapse Core Staff Process & Workspace Changes
  • The Core Staff Inbox now sorts based on last state change for the submission as opposed to last state change for the review. Submissions that have recently changed states will now appear at the top of the Inbox.
  • Prior to release 1.5, if a study team member answered "no electronic document available," to question 1-1.4.1 an auto-generated contingency was created. This auto-generated contingency has been turned off.
  • The Edit Identified Issues activity has been renamed Edit All Issues. The behavior of this activity has not changed. However there is a new activity available to core staff, Edit Open Issues. For issues that are not yet complete, and for creating new issues, core staff will find this new activity more user-friendly.
  • Issues created via the Edit All Issues or Edit Open Issues activity now populate the Created By field.
  • The Full Committee, Expedite, Reassign Expedited Reviewer, and Refer to Designated Reviewer activities across project types in all submission types now have a comment field for communicating with reviewers. Comments entered into this field will appear on all the Committee and Staff Reviewer Checklists for the submission, as well as in the Reviewer workspace for the submission. 
  • For PRC and GCRC only, the Reviewer Checklist will move to the state Finalized when an Action Deferred letter is sent. This allows the PRC and GCRC to create a new Reviewer Checklist every time the committee reviews the submission.
  • When core staff send the Action Deferred Letter, the Staff Review now moves out of the core staff owner's Inbox.
  • The Publish Reviewer Checklist activity now prompts the user to confirm the action prior to publishing the review.
  • Instructions have been added to the Review Study Team Changes checkbox on the Full Committee activity.
  • When an Application is withdrawn, all associated reviews will move to the state Finalized. This will remove the Staff Review from staff owner's Inbox.
  • The Full Committee activity for SCRs and Adverse Events now displays the assigned committee name (e.g. IRBMED A1).
  • When reviewers with a role other than Primary Reviewer submit an expedited review, the associated submission and staff review now correctly change states.
  • Amendment approval no longer updates the Last Continuing Review date.
  • The Disapprove Final activity for amendments now works correctly.

  • The Change Log display was missing links to the changed sections and appeared in triangle format; this display has been corrected.
Expand/Collapse Institutional Biosafety Committee (IBC)
  • Many form changes, including a significant rearranging of the viral vector sections, removal of some questions, and removal of a section.