Post on 14-Jun-2020
September 11, 2018 HRPO SeminarRichard Guido, MD, CIP – IRB ChairMelissa 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 IntegrationCross-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
Roll-Out Plan
• Currently in beta testing: Contact askirb@pitt.edu for access to enter
• Exempt & Expedited undergoing review: 6 approved, 7 in review, 16 in pre-submission
• October 2018: New EE
• Full Board: Beta testing studies expected to go to committee in October 2018
• January 2019: New Full Board Studies
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
Can’t Find My Way HomeNavigating your new Home Page and Study Workspace
QUESTIONS?
Home Page: My Inbox
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
Navigation and Basic Tasks
Study Workspace
HISTORY shows what has taken place, similar to OSIRIS
CONTACTS: Shows info for all who have access
• Draft document accessible for editing
• Final document with watermarking
• Document History
Combines tab for other submissions into one!
Reviews: Latest Details
Reviews: Shows Ancillary Details
A Picture’s Worth a Thousand Words
Start Me UpSubmitting a new protocol
QUESTIONS?
Start Me Up
Red Star = requiredQ6 & 7: irb.reliance@pitt.eduQ8: 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
Let’s give it a try
Tips, Tricks and ToolsQUESTIONS?
Glossary
Reportable New Information (RNI) = Unanticipated Problems (UAP)Reportable New Information (RNI) = Adverse Events (AE)
Continuing Review (CR) = Renewal
Follow-On Submissions = Continuing ReviewsFollow-On Submissions = Modifications
Electronic Data Management = Data Security
Principal InvestigatorListed on the Basic Info page
Principal InvestigatorDetailed on Study Team Members page
Can’t Touch This
Consent forms MUST be submitted with tracked changesNOT highlighting!
Reunited…and It Feels So Good!
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
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!
412-383-1480Main IRB number
askirb@pitt.eduGeneral IRB questions
rcco@pitt.eduTechnical Issues
Questions?If you need a certificate of attendance, email mgm12@pitt.edu