Release Notes Version 1.4

March 4, 2006

Overview of Changes for Core Staff

Overview of Changes for PIs and Study Team members

Expand/Collapse Changes to All Online Forms
  • A Clear button has been added that provides the ability to clear selected radio buttons.
  • The Apply button has been replaced by the Ok and Add Another button.
  • A “Save changes before exiting?” dialog box now appears if changes have not been saved and Exit is selected.
  • The Back button has been removed from the application. The application back button duplicated the functionality of the browser back button and has been removed to avoid confusion.
  • The calendar function in date fields has been updated to support additional internet browsers.
  • When clicking on Print within a form, there is now a Close button in the print window
Expand/Collapse New Application

Form

  • Added Facilitated Review application type to section 1.12. This is ONLY for studies that have already been approved by the NIH NCI Central IRB.
  • The text box for entering the Non-Technical Study Abstract in section 4.1 has been doubled in size to allow 30 lines of text to display.
  • Questions 10.1 and 10.2 have been modified to facilitate selection of the correct informed consent option. A new section, 10-5, has been added to allow for studies requesting exemption. The routing logic has been modified to accommodate these changes.
  • There is now a system requirement for GCRC studies using external sponsors to upload a sponsor budget document. Failure to upload a sponsor budget document will generate an error message.
  • The ability to upload miscellaneous documents has been added back to Section 44. This was previously removed from production because of errors with uploaded documents. The text on this page has also been modified.
Expand/Collapse Amendment Forms/Workspace
  • If an amendment includes a change to the study title, the amendment approval letter now displays the updated title instead of the previous title.
  • Secondary staff owner is now carried over to child submissions.
  • The Edit GCRC Info activity has been added to the workspace.
  • The GCRC study type field now displays in the workspace.
Expand/Collapse Email Notifications/Letters
  • PI and study team members will receive system-generated email notifications for:
    • Submissions that have been in the states Changes Required by Core Staff or Contingencies Pending for 14 days, and again at 28 days.
    • Submissions that have been in the state Pre-Submission for 30 days, and again at 60 days.
    • New applications that have been in the state Complete Application for 30 days, and again at 60 days.
Expand/Collapse Core Staff Functions

Activities

  • For all submissions in the state Core Staff Contingency Review, the activity Changes Requested by Core Staff has been replaced with the Approved with Contingencies activity. This change allows staff to send an updated Contingency letter each time the study team responds to contingencies.
  • The Exempt Review workflow has been corrected so that submissions that are Approved with Contingencies will now move to the state Exempt Approved – Initial when the final approval letter is posted.
  • The Expedite activity has been added to the state Validate Expedite Decision for all submissions. This allows the staff to reassign the submission to a different expediting reviewer or return the submission to the original expediting reviewer.
  • On the Record Expedited Decision activity page the motions of Disapproved and Disapproved Final have been removed.
  • Updates have been made to the Administrative Review process,  including:
    • The Submit Administrative Review activity now moves submissions to the state Validate Administrative Decision.
    • The Approve and Change to Exempt activity has been added for amendments and continuing reviews.
    • The termination letter template has been added to the Approve activity for continuing reviews.
  • The following changes have been made to the Correct Required Core Committee activity page:
    • only one IRB can be selected
    • PRC and GCRC have been removed as options
    • the staff owner is cleared upon completion of the activity allowing the study to display on the Unassigned Applications tab for the new IRB
    • the completed activity displays on both the Correspondence and History tabs
    • the activity sends a notification to the PI and the study team members
    • a comment field has been added
  • Users with the role Core Committee Super Admin can now submit all application types on behalf of the PI.
  • The Inbox Staff Notes can now be edited on the Changes Requested by Core Committee Staff activity page.
  • The Approve activity page for Emergency Use submissions no longer displays an error message when no expiration date is entered.
  • Studies that have received approval by the NIH NCI Central IRB can now be processed in eResearch using Facilitated Review, which is included in the Expedited Review workflow. A Facilitated Review option has been added to the list of Expedited categories on both the Expedited and Submit-Edit Expedited Review activity pages.
  • The Edit Committee Members detail page now allows staff to update Conflict of Interest and Areas of Expertise.
  • In the Assign Owner activity page for Adverse Events, the select owner process has been changed to match all other Assign Owner activity pages.
Expand/Collapse Workspace

Home Workspace

  • The following information now auto-populates in the Staff Notes column upon submission:
    • New Applications
      • Study Type (Umbrella, Standard, Emergency Use, Humanitarian Use Device, Facilitated Review)
      • Exemption
      • Student Project
      • Waiver
      • Documentation Waiver
    • Amendments
      • Study Type (Umbrella, Standard, Emergency Use, Humanitarian Use Device, Facilitated Review)
      • Expiration date at time of submission
      • Review Type of parent submission (Expedited or Full Board)
    • Continuing Reviews
      • Study Type (Umbrella, Standard, Emergency Use, Humanitarian Use Device, Facilitated Review)
    • Adverse Events
      • Study Type (Umbrella, Standard, Emergency Use, Humanitarian Use Device, Facilitated Review)
  • The following information now auto-populates in the Staff Notes column when a review is submitted:
    • All submissions
      • Primary review submitted
      • Expedited review submitted
      • Contingency review submitted
  • The following information now auto-populates in the Staff Notes column when a new application is approved:
      • Expiration date

Submission Workspace

  • The “Agenda Item History” data now displays on the History tab for studies that are Action Deferred
Expand/Collapse Committee Information
  • Co-investigators are now listed on the PRC agenda.
  • On the Submit-Edit Expedited Review activity page the motions of Disapproved and Disapproved Final have been removed.