Patty Orndoff RN, MEd IRB Education Coordinator University of Pittsburgh Institutional Review Board Presents: “OSIRIS” Online Submission for Institutional Reviews www.osiris.pitt.edu Patty Orndoff RN, MEd IRB Education Coordinator

OSIRIS Introduction Single, dynamic, comprehensive electronic compliance system Utilizes smart forms which provide extensive branching questions to acquire information Automated review process based on responses in smart form Single submission process for required pre-IRB approvals and IRB review

OSIRIS (con’t) Automated logging and tracking system Automated email notifications to permit direct communication between review entities and research staff Emails to study team sent to PI and Primary Research Coordinator Internet based – available 24/7 with global access

Project Scope New Studies – Full Board, Expedited and Exempt (March 2007) Renewals Modifications Unanticipated Problems (includes adverse events) Exceptions (pending) Suspensions Terminations Committee Meetings Help/Support Paper Conversion process (TBA 2008)

Getting Started……… Logging on requirements Build the application Submit for review Final Approval

Pre-IRB Reviews Mentor Department/CTRC Review Scientific Review Committees UPMC Research Fiscal Review RDRC/HUSC (radiation) Institutional Biosafety Committee (IBC) Conflict of Interest

Notification Occurs Automatically When Investigator Submits the Study to OSIRIS Investigational Drug Service CTRC (if resources are utilized)

Log In Requirements All personnel involved with Human Subject Research are required to complete Internet-Based Studies in Education and Research (ISER) training Required modules include: Module 1 - Research Integrity and Module 2 - Human Subject Research 2a (Biomedical) or 2b (Social/Behavioral) ISER training is an online training system which can be found at: https://cme.hs.pitt.edu

Principal Investigator Role Responsible for the conduct of the study Only the PI can submit a project for review Carefully review the entire document before submitting Must respond to all concerns expressed by reviewers Do Not share your password!

Study Coordinator Role Prepare study information Enter data into Osiris Scan documents if needed Contact sponsor if needed Track study progress in system over time Note: Only the PI can submit the IRB application to OSIRIS

OSIRIS Home Page

Login Page Entire Email Address and Password used to complete Education/COI modules

Home Page and “My Roles”

OSIRIS Application Triage section Cover sheet section Protocol section Once completed, all names listed in the application will have access to the study Cover sheet section Demographic and site information Protocol section Protocol development

Getting Started

Create New Study Help Text

Drop-Down List Provides Quick Access to Specific Sections (Do not use for Exempt Studies)

Who can initiate the submission? Any member of the research team can start developing the application but…. The person who initiates the study is automatically listed as the PI If you are not the PI Go directly to the section CS3.0 and correctly identify the PI

Select or Change PI

Able to upload multiple documents, one at a time Uploading Documents Able to upload multiple documents, one at a time

Consent Form Templates Click “Add” to upload new consent form(s) or “Edit” to revise any previously uploaded consent form(s)

Revise Consent Form Click on “Edit” to upload revised form (i.e., modify consent or respond to comments)

Consent Form Watermark Footer

View Progress

Hide/Show Errors

Submit Project for Review

“Current State” and “History” Both Show Application is in IRB Review

Changes Required by IRB Staff Click on Underlined Text beside “jump”; you will be redirected to specific page to insert your response to comments When you “Click here to respond” a textbox opens so you can indicate what changes are completed or disputed

“IMPORTANT” Complete the changes requested within the application (SAVE) and then use the Click here to document that you made the change 2nd 1st

“Current State” Shows Study is Approved and the Approval Letter & Consent Forms are Available

Reviewer Version

Approval Letter

Project ID Study name = PRO07010001 Renewal name = REN08010034 Assigned new ID Modification name = MOD07010001-01 Same study ID with consecutive version numbering Unanticipated Problem = UAP07060004 Includes both adverse events and other unanticipated problems

Sharing OSIRIS documents Print or email Reviewer Version Includes all questions/responses html format Attachments Consent forms in Word All uploaded documents Open document, save to your computer, and attach to an email message or server if needed

IRB Website (www.irb.pitt.edu)

Contact us by clicking on the Help tab located on each page of OSIRIS or email us at irb@pitt.edu OSIRIS training – contact Patty Orndoff orndoffpa@upmc.edu We welcome written suggestions for enhancing the application

Need Some Playtime… Go to our Sandbox