October 8, 2018 HRPO Seminar Jean Barone, CIP – HRPO Director Melissa Miklos, MSL, CIP – HRPO Associate Director

Why Change from OSIRIS? OSIRIS is old (2004) Extremely customized Doesn’t play well with others

Huron’s IRB Solution: PittPRO Increased collaboration: Used by 40+ AAHRPP Accredited Institutions Active User Group to share best practices Incorporates regulatory changes as they occur Common Rule, January 20, 2019 Includes Library, Toolkit and Help Center to support users Single IRB Review models Cloud-based environment to enable collaborating institutions to see each other’s work

University of Pittsburgh Integration Cross-system sharing of information with rapid access to data (coming)

Development History Listened to feedback through lifetime of OSIRIS Collaborated with Huron & University offices on products Engaged Research Community in early stage development and testing and incorporated changes Limited roll-out of PittPRO to willing researchers for Beta Testing Mutli-Disciplinary task force was created to ensure that the system, historically leaning toward clinical trials, was streamlined to meet the needs of social-behavioral-educational researchers. Study scope was developed as a result so that only relevant questions would show

Roll-Out Plan Currently in beta testing: Contact askirb@pitt.edu for access to enter Exempt & Expedited nearly 100 studies entered October 15, 2018: ALL new EE submit to PittPRO Full Board: Beta testing studies expected to go to committee in October 2018 January 2019: ALL new Full Board Studies submit to PittPRO NOTE: if you put your full board study into the system without letting us know, it may be severely delayed!!!!

Transition Plan All active studies in OSIRIS will convert When: Renewal date July 1, 2019 or beyond Enter as a new study; enter OSIRIS PRO# Attach paper renewal form NO modifications at conversion So really, you need to submit your Continuing Review/transition protocol in or around April.

Can’t Find My Way Home Navigating your new Home Page and Study Workspace QUESTIONS?

Navigation and Basic Tasks Find Stuff: My Inbox Submissions that require your action Actions you can perform (create) Shortcuts to access other items Do Stuff Review submissions in inbox Check the state of items (e.g. Pre-Submission means you need to finish and submit) Submit stuff “Create new study” to start Click on study name to open it

Home Page: My Inbox

Study Workspace

HISTORY shows what has taken place, similar to OSIRIS

CONTACTS: Shows info for all who have access Gives contact info not just for study team, but for all others who have access – including ancillary reviewers

Draft document accessible for editing Final document with watermarking Document History Draft document accessible for editing Final document with watermarking Document History: ability to see all versions of document and choose two to compare

Combines tab for other submissions into one!

Reviews: Latest Details Shows all of the latest details about reviews Reviews: Latest Details

Reviews: Shows Ancillary Details Shows all of the latest details about reviews Reviews: Shows Ancillary Details

A Picture’s Worth a Thousand Words Training Tab: I skipped this one but it gives the training records of the study team, just like OSIRIS

Start Me Up Submitting a new protocol QUESTIONS?

Start Me Up

*Red Star = required Q6 & 7: irb.reliance@pitt.edu If you don’t have a protocol to upload, don’t worry – NO RED STAR! Note Red Stars for mandatory answering Question 6 & 7 – contact IRB reliance team (irb.reliance@pitt.edu) Question 8: Exempt Form goes here! *Red Star = required Q6 & 7: irb.reliance@pitt.edu Q8: Upload protocol or exempt form

Required Sections

Data Security No longer a separate form

Ancillary Reviews Certain of them are selected based on response Few can be manually selected Link to extra info Gives map to trigger questions Scientific & Mentor in Pre- Submission Others simultaneous in Pre- Review

Tips, Tricks and Tools QUESTIONS?

Glossary Follow-On Submissions = Continuing Reviews Follow-On Submissions = Modifications Continuing Review (CR) = Renewal Electronic Data Management = Data Security Reportable New Information (RNI) = Unanticipated Problems (UAP) Reportable New Information (RNI) = Adverse Events (AE)

Principal Investigator Listed on the Basic Info page

Principal Investigator Detailed on Study Team Members page

Can’t Touch This Consent forms MUST be submitted with tracked changes NOT highlighting! IRB cannot make changes or upload a “clean” copy. A MODIFICATION would need to be submitted!!!!

Reunited…and It Feels So Good! This is great but remember you need to give yourself more lead time because the modification may cause it to be approved subject to mods. -be careful if your mod is expeditable because you CANNOT split the renewal and mod. If the renewal is full board, so is the mod and vice versa.

Modifications Mod “cover sheet” incorporated into modifiable protocol Exempt studies can be modified like any other

One stop to justify modifications -Rationale and support for the change being made Note the RED STAR by #3 Explain WHAT is being changed and WHY

Continuing Review (CR)

Continuing Review: Study Status

Reportable New Information One RNI: Multiple studies

Reportable New Information

I Still Haven’t Found What I’m Looking For

HELP! I Need Somebody! 412-383-1480 Main IRB number askirb@pitt.edu General IRB questions rcco@pitt.edu Technical Issues

Let’s give it a try http://www.pittpro.pitt.edu/ http://www.pittpro.pitt.edu/pittpro http://dev.osiris.pitt.edu/PITTPRO-DEV/sd/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity[OID[CFC632CA9AFAE24DBCF139EC0E1690E3]] http://www.pittpro.pitt.edu/

Questions? If you need a certificate of attendance, email mgm12@pitt.edu