1.1 - new option to select a Humanitarian Use Device. a HUD formset backs up the selection of HUD from the type of submission.
8.3 display now will get more information to display from TRUE2
Page 9: New question on Community Engaged Research added
18.3.1. specifically calls out MDDS as a product used according to its labeling.
Page 23 - checkboxes for 23.1 and 23.2 available. For USC, the questions 23.3 and 23.4 have been deprecated and are no longer required for new submissions.
27.1 and 27.2 now have additional checkboxes for venipuncture
35.2 now has an asterisk after "code" to reflect the possibility that a code be included in the limited data set under certain conditions.
35.3 now has a link to the USC Data Use Agreement template.
Amendment Changes
There is now only ONE form that combines both the amendment and the editable copy of the study. The amendment potion shows up prior to the study form pages.
The questions on enrollment and informing subjects of changes have been moved to amendment page 5. Also, when subjects are in need of being informed two questions show up asking for detail on how and when this will be done.
New Project Type: Emergency Use Application. For emergency use of drug, device, or biologic, we now have a form to capture required information. The form is very short and workflow very abbreviated, in keeping with the regulations.
Review Time information and graphs are available for every study and amendment to disclose how much time the study staff, IRB, or dept/div reviewers are responsible for prior to approval. This can be found on its own tab, called "Time" in the study or amendment workspace.
New Reports functionality created to facilitate better reports from iStar and better scheduling of periodic reports.
Back end way in which training is displayed has been redone to enable display of certifications and course completions anywhere people are displayed.
Study Read policies have been significantly altered to increase speed of page rendering.
Web service between TRUE2 and iStar has been updated to supply additional information.
IACUC Changes:
IACUC Form:
pain/discomfort page drug/dosages corrected
breeding page altered
Ability to attach monitoring reports added
Response to contingencies fixed
Missing email messages fixed
DMR email banner fixed
DMR need only be one person now (used to be two)
History formatting corrected between comments and stipulations
All staff listed on protocol get notified
IBC - The Institutional Biosafety Committee is planned to have an online system go live befor the summer. This system will use iStar also. This release of iStar will include much of the plumbing and technical work necessary for this, including:
First draft of the BUA form
workflow for IBC (states, transitions, activities)
