Release Notes Version 1.3

November 12, 2005

Expand/Collapse New Application


  • Section 1 - Added the ability for others to upload CVs/Personal Bios for PIs and Co-Is
  • Section 1 - Study Title no longer defaults to "_Protocol..." when left blank
  • Section 1-1.1 - Added text box to define "Other"
  • Section 1-6.7.2 - Wording change
  • Section 2 - Added Help to assist users with sponsor search
  • Section 5 - Changed reference to attached protocol
  • Section 8 - Changed 8-1
  • Section 8 - Added question 8-6.3.1
  • Section 10 - Changed Informed Consent sections
  • Section 11 - Allow applicants to upload the certificate of confidentiality.
  • Section 15.2 - Form change for IDS Waiver
  • Section 14 - Eliminated question 14.1; other questions renumbered
  • Section 21-1 - Added same validation on the detail page at 21-1.1 as in 1.3
  • Section 25.1 - Changed Hospital/Doctors list
  • Section 42 -GCRC-related form changed 
  • Section 42-1 - Removed AXIS I and II questions
  • Section 44 - Added new section at end of application for additional documents

Printable Version

  • Corrected Detail Pages Display In Printer-Friendly Version
  • Removed unnecessary Detail Section in Printer-Friendly Version
Expand/Collapse Workspace
  • Added required indicator to Credentials on Accept Role and Submit Application activity windows
  • Accept role updates CV for Co-Is and Faculty Advisors.
  • Updated Accept Role display value for Study Team Members
  • Changed PEERRS table information
  • Added Work Address Information to Study Team Detail Page
  • Added Approval Date to Approved Study Summary Information
  • Documents uploaded in section 2.4 now display on Documents tab
  • Changed label in Approved New App Template to "Create New Submission"
  • Added Staff Owner field to Approved Study Workspace
  • Data now displays on All Studies Tab
  • Studies in Expired - Continuation in Progress now display in Study Team Workspace or in All Studies under the Archived tab
  • Changed "Folder For [NAME]" to "Home For [NAME]"
  • Added an activity for SCR 30/60/90 Notices to Correspondence tab
  • Corrected "New AE/ORIO" label in Approved Study workspace
Expand/Collapse Amendment Forms/Workspace
  • Added Change Tracking for Amendments in Expedited Review
  • Added Submit Changes to Core Staff activity to Correspondence tab for Amendments
  • Corrected reference to Informed Consent in Amendment Cover Sheet
Expand/Collapse AE/ORIO Forms/Workspace
  • Section 6.3 - “Seriousness” defined and guidance provided on how to measure it.
Expand/Collapse SCR Forms/Workspace
  • Significantly changed SCR forms – reorganized sections and smartform logic
  • Added Documents & Change Tracking tabs for SCRs In Expedited Review
  • Added "Pending Contingencies" tab to Continuing Review Workspace
  • Added "Publications Related to this Project" Question to SCR
Expand/Collapse Notifications/Letters
  • Updated Expiration Notices
  • SCR approval letter populates Exempt category
  • PRC Approval Letter Errors
  • Provide email notification to PRC staff when new submissions are sent to PRC
  • Added additional signatures to letters
  • Changes to Expiration/Renewal messages
  • Added DRDA as a Cc on Approval Notices
  • Added Submit Changes to Core Staff activity to Correspondence tab for Amendments and SCRs
  • Revised PRC Approval Letter
  • Changed Expiration Notice background task
  • Text changes to email notifications
  • Updated PRC approval letter activity
  • Changed Post Correspondence Core Staff email notices
  • Updated 30/60/90 notification letters
  • Updated Reviewer Letter templates and Expiration Notices
Expand/Collapse Reviewer Functions
  • Added ability for IRB Health and BehavSci Committee Members  to view reviewer notes entered by assigned reviewers
  • Added name of parent study to agenda for Amendments and SCRs
  • Added Total Votes field to Record Committee Decision for Amendments
  • Added PRC Summary to PRC Agenda
  • Changed name of activity for Submit PR and SR review
  • Changed Reviewer Checklist/Reviewer Notes functionality
  • Added "None" option to list of approval periods on Submit Review
  • Added exempt categories to Record Expedite Decision for new applications
Expand/Collapse Core Committee Staff Functions


  • Corrected Agenda History for all submission types. Meeting information cannot be modified after sending out decision notice.
  • Added two kinds of "Action Deferred" in the Workflow
  • Corrected an issue where Request Clarification or Changes broke the workflow
  • Added activities and states for Administrative Approval.
  • Expiration Date carries from Submit Expedite Review to Record Expedite Decision
  • Updated Expiration Date setting for Expedited studies
  • Expiration Date field appears in Exempt study workspace and is completed when staff completes Termination Approval
  • Outstanding contingencies now only prevent approval at the IRB review
  • Updated contingency created for FWA requirement
  • Updated change to parent study's status bar state after an amendment is approved
  • AEs submitted on Terminated Studies no longer go to "Held for Continuing Review"
  • Can now edit minutes for first agenda while submission is assigned to a second meeting’s agenda and the submission is Action Deferred.
  • Meeting History no longer displays duplicate records in Workspace and Submission Summary
  • Activity added to Finalize Documents for recruitment materials
  • Updated Submit SR Review Activity
  • Complete Expedite activity now requires an assigned reviewer
  • Core Staff can no longer edit Question 11-1.2
  • Added Submit Contingency Review activity to History tab
  • Continuing Reports automatically select the IRB for IRB-BSHS studies
  • Issues related to "Approve & Change to Exempt"


  • Removed requirement to add reviewer when assigning new applications and amendments to Full Committee
  • Added a Comments field to Manage Contingencies so offices can use it for noting location of hard-copy docs.
  • Added a Prepare Letter activity to Core Committee Staff Contingency Review
  • Updated order of IRBMED Committees Assign Committee activity
  • Added selection to Administrative Withdrawal/Termination activity


  • Added a Create New User button to Core Staff Home Workspace
  • Added Filter function to various staff & reviewer tabs
  • Not Regulated activity now displayed on the Correspondence tab
Expand/Collapse Reports
  • Updated PRC Query
  • Added PRC Summary Reports
  • Added Query by PI
  • Updated Results of Expedited-Exempt Review Report
Expand/Collapse Committee Information
  • Updated Inactive Committee Members display in committee workspace
  • Added Committee Member Role of Support Staff
  • Added the ability to add non-committee members to meeting attendees who receive agenda
  • Select alternate member displays committee member list in Committee Member Detail
  • Corrected IRB Behavioral Science committee members
  • Added Time of Activity to Update Meeting History activity page