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.

December 2020

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

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. 
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

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. 
2. DEC outcome letter updated to pull in the type of action the user is submitting: Initial Review, Amendment or Continuing review.
3. Added "Deputy Director" role to the Scientific Review Form  routing list. 
4. Renamed "Ad Hoc" Reviewer Role to "Ad Hoc Consultant" 
5. Updated Study Application Research Site question 4 from "Policy 105 and Policy 109" to "Policy 100". 

September 2020

1. Non-human Subjects Research Outcome Letter has been revised - 
2. Changes to Questions 4.6, 4.7, 4.9 within the Non-human Subjects Research Outcome Study Application
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. "  
4. Removed of FWA#, Site PI, Phone and Email columns from Section 6.1 
5. Added reference number to Agenda Reviewer Assignment Notification, Expedited Reviewer Assignment Notification, Process Administrative Reviewer Assignment Notification 
6. Added submission types: stipulation notification, corrections notification
7. Submission types for DEC outcome letters added: Initial Review, Continuing Review, Amendment, and Continuing Review and Amendment 

August 2020

1. Question Mark Help Icon now has links to the Helpdesk Ticketing System and the Training Email -
2. IHS Screening Question added to Study Application - Question 6.2 - 

3. Updated policy from Policy 201 to Policy 103 - Present in Initial Review Submission Form, Amendment Form, Present Progress Report Form

4. Study Application question 4.1 updated to remove reference to the now deleted section 6

July 2020