1 Release 2.0 System Enhancements MAIS Connection Conference November 19, 2008

2 Agenda User Feedback Release 2.0 Features Customized Paths though Application Exempt Not Regulated Studies requesting review from a non-UM IRB Usability Online Help Format Conditional Display of Questions Workspace Modifications Non-Key Personnel Changes Workflow for Amendments Clinical Research Billing Release 2.0 Schedule Training & Communications

3 User Feedback Feedback gathered from the following initiatives Streamlining Working Group Surveys of Study Teams eResearch Team Office of Human Research Compliance Review (OHRCR) Individual Meetings with PIs and Study Coordinators School of Information Usability Project Feedback addressed in eResearch system Release 2.0 Application is too long Questions aren’t relevant to study team’s research System interface and design usability Difficulty adding and removing “non-key” personnel Required committee approvals for amendments

4 Enhancements for Release 2.0 Customized Paths Through Application New Smart Form logic routes study team through shorter application paths depending on the type of application Wider array of application types for study team to select from in section 1-1 of the application Definitions and Validation will assist in confirming that the study team has selected the correct type

5 Enhancements for Release 2.0 Customized Paths Through Application New Application Types: Exempt: only study teams that select the exempt application type will have to respond to exempt questions (see handout for detail on path) Not Regulated: study teams will be able to print a “Not Regulated” determination letter without having to submit to an IRB (unless it requires Privacy Office review, which has been added in the application) Requesting Review by another IRB (UM ceding oversight)

6 Enhancements for Release 2.0 Usability Application Form Changes: Remove questions Reword and move questions that cause greatest number of issues Redesigned Help Conditional Display throughout application

7 Enhancements for Release 2.0 Study teams that select “No” do not see the questions that are required with a “Yes” response Conditional Display

8 Enhancements for Release 2.0 Usability Home Workspaces Modeling after new Proposal Management system which was designed based on Regulatory Management system feedback and usability testing Moving Tabs: important study information will be displayed at the top of the screen Removing items that do not add value for study teams or staff (e.g. activity icons)

9 Enhancements for Release 2.0 Non-Key Personnel Changes Study Teams will no longer have to create and submit an amendment to change non-key personnel Approximately 20% of amendments include personnel changes

Enhancements for Release 2.0 Committee Approval for Amendments Amendments will only go through the ancillary and core committees where information relevant to that committee has changed All amendments will continue to go through the IRB 10

Enhancements for Release 2.0 Clinical Research Billing Unit (CRBU) Questions related to the CRBU “Initial Review Form” will be included in the application CRBU will not be added as an ancillary committee for this release 11

12 Schedule Release Schedule Fall 2008 Release Michigan Institute for Clinical Health & Research (MICHR) changes Preview Release 2.0 changes Winter 2009 Release 2.0

13 Training & Communications IRB Staff Training Overview Presentation Demos & Lab Sandbox preview Communications eResearch website Home Workspaces Targeted s

14 Training & Communications PI & Study Team Training Overview Presentation & Demos Labs after system is live Updated Training Materials Communications eResearch website Home Workspace messages Targeted s

15 Questions