iRIS Knowledge Base

Space shortcuts

Page tree

This is a space for the iRIS team to update a running list of release notes for changes made on an ad-hoc, or on a release basis.  It will be kept up to date, and shared with the team weekly in our iRIS Project Check In meeting. 

March 2020

  1.   References to "local" have been removed from Amendment form. IENH-242 - Getting issue details... STATUS

December 2020

  1.   Reviewer Checklist updated modified  IENH-210 - Getting issue details... STATUS
  2.   Help text added to study application IENH-217 - Getting issue details... STATUS IENH-222 - Getting issue details... STATUS
  3.   Updated language in study application and amendment form regarding study population  IENH-223 - Getting issue details... STATUS
  4.   Changes Study Application section 7 IENH-224 - Getting issue details... STATUS
  5.   Added changes to the Amendment submission form (external site tracked consent option to the list) IENH-227 - Getting issue details... STATUS
  6.   Enable property to require PI sign off on Initial Review, Amendment and Progress Report Forms IENH-229 - Getting issue details... STATUS
  7.   Enable property to only allow one Amendment and Progress Report form to be submitted at a time.   IENH-230 - Getting issue details... STATUS
  8.   Indian Health Services (IHS) changes to application IENH-237 - Getting issue details... STATUS

November 2020

  1. Study App Question 5.22 Updated with new text: Are there any commercial, FDA approved products used as the object of the investigation?If yes, please list each product in the table below.  IENH-214 - Getting issue details... STATUS
  2. Added "Inactive" to the status dropdown list for tables 7.4 and 7.6 and "Relying on a Non-IRB memo" has been added to the outcome templates IENH-224 - Getting issue details... STATUS

October 2020

  1. Changed language of the Decisionally Impaired Subjects question of the Outcome For, change will only be reflected on submissions that reach the board after the revised form is published.  IENH-215 - Getting issue details... STATUS
  2. DEC outcome letter updated to pull in the type of action the user is submitting: Initial Review, Amendment or Continuing review. IENH-211 - Getting issue details... STATUS
  3. Added "Deputy Director" role to the Scientific Review Form  routing list.  NIHIRB-2456 - Getting issue details... STATUS
  4. Renamed "Ad Hoc" Reviewer Role to "Ad Hoc Consultant"  IENH-219 - Getting issue details... STATUS
  5. Updated Study Application Research Site question 4 from "Policy 105 and Policy 109" to "Policy 100".  IENH-220 - Getting issue details... STATUS

September 2020

  1. Non-human Subjects Research Outcome Letter has been revised -  IENH-198 - Getting issue details... STATUS
  2. Changes to Questions 4.6, 4.7, 4.9 within the Non-human Subjects Research Outcome Study Application IENH-194 - Getting issue details... STATUS
  3. Updated the following letters: Determination Amendment of Exempt Study, Determination Exempt Outcome Letter with the language ""Federal regulations and/or NIH policy require prompt reporting of any non-compliance, including major protocol deviations, or unanticipated problems involving risks to subjects or others, or serious harm involving subjects, to the IRB. "   IENH-204 - Getting issue details... STATUS
  4. Removed of FWA#, Site PI, Phone and Email columns from Section 6.1  IENH-197 - Getting issue details... STATUS
  5. Added reference number to Agenda Reviewer Assignment Notification, Expedited Reviewer Assignment Notification, Process Administrative Reviewer Assignment Notification  IENH-203 - Getting issue details... STATUS
  6. Added submission types: stipulation notification, corrections notification IENH-202 - Getting issue details... STATUS
  7. Submission types for DEC outcome letters added: Initial Review, Continuing Review, Amendment, and Continuing Review and Amendment  IENH-211 - Getting issue details... STATUS

August 2020

  1. Question Mark Help Icon now has links to the Helpdesk Ticketing System and the Training Email - IENH-200 - Getting issue details... STATUS
  2. IHS Screening Question added to Study Application - Question 6.2 -  IENH-199 - Getting issue details... STATUS

  3. Updated policy from Policy 201 to Policy 103 - Present in Initial Review Submission Form, Amendment Form, Present Progress Report Form IENH-196 - Getting issue details... STATUS

  4. Study Application question 4.1 updated to remove reference to the now deleted section 6 IENH-195 - Getting issue details... STATUS

July 2020
  • No labels