September 11, 2018 HRPO Seminar Richard Guido, MD, CIP ... PittPRO Sept 2018_0.pdf · Melissa...
Transcript of September 11, 2018 HRPO Seminar Richard Guido, MD, CIP ... PittPRO Sept 2018_0.pdf · Melissa...
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September 11, 2018 HRPO SeminarRichard Guido, MD, CIP – IRB ChairMelissa Miklos, MSL, CIP – HRPO Associate Director
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Why Change from OSIRIS?
• OSIRIS is old (2004)• Extremely customized• Doesn’t play well with others
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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
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University of Pittsburgh IntegrationCross-system sharing of information with rapid access to data (coming)
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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
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Roll-Out Plan
• Currently in beta testing: Contact [email protected] 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
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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
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Can’t Find My Way HomeNavigating your new Home Page and Study Workspace
QUESTIONS?
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Home Page: My Inbox
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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
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Study Workspace
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HISTORY shows what has taken place, similar to OSIRIS
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CONTACTS: Shows info for all who have access
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• Draft document accessible for editing
• Final document with watermarking
• Document History
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Combines tab for other submissions into one!
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Reviews: Latest Details
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Reviews: Shows Ancillary Details
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A Picture’s Worth a Thousand Words
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Start Me UpSubmitting a new protocol
QUESTIONS?
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Start Me Up
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Red Star = requiredQ6 & 7: [email protected]: Upload protocol or exempt form
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Required Sections
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Data Security
No longer a separate form
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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
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Let’s give it a try
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Tips, Tricks and ToolsQUESTIONS?
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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
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Principal InvestigatorListed on the Basic Info page
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Principal InvestigatorDetailed on Study Team Members page
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Can’t Touch This
Consent forms MUST be submitted with tracked changesNOT highlighting!
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Reunited…and It Feels So Good!
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Modifications• Mod “cover sheet”
incorporated into modifiable protocol
• Exempt studies can be modified like any other
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One stop to justify modifications-Rationale and support for the change being made
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Continuing Review (CR)
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Continuing Review: Study Status
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Reportable New Information
One RNI: Multiple studies
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Reportable New Information
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I Still Haven’t Found What I’m Looking For
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HELP! I Need Somebody!
412-383-1480Main IRB number
[email protected] IRB questions
[email protected] Issues
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Questions?If you need a certificate of attendance, email [email protected]