Transitions, Continuing Reviews and Modifications Tuesday, … CR Mod Feb 2019b.pdf · HRPO...

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streamlined process• Minimize the footprint of the outdated OSIRIS system• Provide robust study information to tie into PERIS• Engage in multi-site reviews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: irb.reliance@pitt.eduQ7: 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

askirb@pitt.eduGeneral IRB questions

rcco@pitt.eduTechnical Issues

Questions?Email askirb@pitt.edu