NIH iRIS Release Notes

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. Unable to locate Jira server for this macro. It may be due to Application Link configuration.

December 2020

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

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.  Unable to locate Jira server for this macro. It may be due to Application Link configuration.
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 Unable to locate Jira server for this macro. It may be due to Application Link configuration.

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

September 2020

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

August 2020

1. Question Mark Help Icon now has links to the Helpdesk Ticketing System and the Training Email - Unable to locate Jira server for this macro. It may be due to Application Link configuration.
2. IHS Screening Question added to Study Application - Question 6.2 -  Unable to locate Jira server for this macro. It may be due to Application Link configuration.

3. Updated policy from Policy 201 to Policy 103 - Present in Initial Review Submission Form, Amendment Form, Present Progress Report Form Unable to locate Jira server for this macro. It may be due to Application Link configuration.

4. Study Application question 4.1 updated to remove reference to the now deleted section 6 Unable to locate Jira server for this macro. It may be due to Application Link configuration.

July 2020