Transitions, Continuing Reviews and ModificationsTuesday, February 26, 2019HRPO Seminar, 1104 Scaife Hall
Transitions, Continuing Reviews,and Modifications
Transitions
Transition Goals • Efficiently add new studies so that investigators can enjoy
streamlined process• Minimize the footprint of the outdated OSIRIS system• Provide robust study information to tie into PERIS• Engage in multi-site reviews
Existing StudiesActive studies in OSIRIS will transition to PittPRO (Continuing Review date of March 15, 2019 or beyond)
• Data Analysis Only, Long Term Follow Up & non-continuing review studies in OSIRIS stay in OSIRIS (FOR NOW)
• EXT studies stay in OSIRIS
• sIRB studies stay in OSIRIS
What about the Common Rule Changes?
Compliance with 2018 Rule is not required for transitioning protocols!
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What do I need to have handy?Username and Password (Same as OSIRIS)Access to current OSIRIS protocol and all
attachmentsAccess to renewal data for existing protocolTip Sheet for OSIRIS ConversionsTransition Continuing Review FormData and Safety Monitoring Reports
Tip Sheet for Conversion
How do I make the transition happen?
*Red Star = requiredQ6: [email protected]: choose single site onlyQ8: Upload protocol or exempt form
Study Scope #10
Transition CR Form
Continuing Review (CR)
What will the IRB review? IRB Analyst will complete pre‐review to ensure consistency with
OSIRIS – may result in comments
SUBSTANCE: (it is a continuing review)• Must still satisfy criteria for IRB Approval at 45 CFR 46.111• Determine the risk, potential benefits, informed consent process and safeguards
for human subject protection are acceptable at time of renewal• Evaluate the number of subjects actually enrolled to the expected rate of
enrollment• State if the study should continue as previously approved• Discuss risk classification (minimal risk v. greater than minimal risk)
No modifications at time of transition!(You may clean up your submission, removing old consent forms, documents not in use, etc.)
Ancillary Reviews• Most bypassed for
transitioning studies except:
• RCCO Business Manager for Industry Sponsored Studies
• IRB reserves the right to request others
Why might I need a data security review?
• Proper info not disclosed on Data Security Assessment Form in OSIRIS
• Data Security Assessment form never completed
Remove OSIRIS Footer Box from Consent Form!
What about my study in OSIRIS?Once FINAL approval is received through PittPRO, close the OSIRIS study
Questions about Transitions?
Continuing Review
Continuing Review? I thought you said I didn’t have to do this anymore.
Sometimes You Don’t Sometimes You Do
• Research eligible for expedited review
• Research limited to data analysis of identifiable private info or identifiable biospecimens
• Research that accesses follow‐up clinical data that subjects undergo as a part of their clinical care
• Greater than minimal risk research• FDA regulated research• Research that requires additional or
ancillary oversight• Includes international or non‐local
sites• History of non‐compliance• Biorepositories
How do I create a Continuing Review?
Continuing Review (CR)
Think Research Milestones = Research Endpoints (suspension/closure/termination of approval)
If the study is open to enrollment, do not check any boxes!
Continuing Review: Research Milestones
Continuing Review: Research Milestones
Nothing can be done to undo this! A new study would need to be submitted
Continuing Review: Annual Progress
Unchecked boxes require upload of supporting materials
Release from Continuing ReviewIf the study is released from continuing review, no expiration date will be issued in the letter or on the watermarked consent form
Released from CR:
CR Required:
Questions About Continuing Review?
Modifications
How do I create a modification?
Use caution when submitting combined!
Modification Scope Selections
1st option2nd option
Both options
One stop to justify modifications-Rationale and support for the change being made
Modifications• Mod “cover sheet”
incorporated into modifiable protocol
• Exempt studies can be modified like any other
• “Modification Details launches into the protocol so changes can be made
Check out the Changes Prior to Submission
Questions about Modifications?
General Notes
System watermarks consent forms and
recruitment materials
Red asterisk * = required responseLimited to manage exempt projects
Approval letter will list all approved
documents uploaded
Managing Your Profile
• Update in PittPRO
• Update in HSConnect
• Use employer email address
• Pitt employees should use their Pitt email address
Other Activities
Returns to Pre‐Submission state where you can choose to change and resubmitWithdraw
Permanently removes this submission from reviewDiscard
Add Comment: Visible to all and you can choose who should receive the email (PI/Primary Contact, Study Team, IRB Coordinator)
Add
Request Exception Request
Request SuspensionRequest
Update Clinical Trial InformationUpdate
HELP! I Need Somebody!
412-383-1480Main IRB number
[email protected] IRB questions
[email protected] Issues
Questions?Email [email protected]