eResearch Release Notes, Version 1.3

New Application

Forms

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

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

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

AE/ORIO Forms/Workspace

SCR Forms/Workspace

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

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

Access Requests

Core Committee Staff Functions

Workflow

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"

Activities

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

Workspace

Reports

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