i just submitted to the irb… what now?. have i really submitted it?? (not in this case - click the...
TRANSCRIPT
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I JUST SUBMITTED TO THE IRB… WHAT NOW?
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HAVE I REALLY SUBMITTED IT??(NOT IN THIS CASE - CLICK THE YELLOW BOX)
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CLICK ON THE ROUTING ASSIGNMENT LIST ICON
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YOU HAVE NOT CLICKED “SAVE AND CONTINUE” TO BEGIN ROUTING
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SIGNATURES ARE STILL NEEDED:“WAITING FOR PI SIGNOFF”
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SIGNATURES ARE STILL NEEDED:“IN PROCESS” VS. “COMPLETED”
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CHECK TO SEE WHETHER THE IRB HAS RECEIVED IT
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YES! I DID IT!
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AFTER AN IRB ANALYST IS ASSIGNED,HOW DO I TRACK IT?
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CLICK “TRACK LOCATION”
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OK, THIS IS WHOM I SHOULD CALL WITH QUESTIONS.
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REVIEWERS HAVE COMPLETED THEIR REVIEWS
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I NEED TO RESPOND TO THE IRB!CLICK TO OPEN FROM YOUR “INCOMPLETE TASKS”
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OR: GO TO “PROJECT ASSISTANT,” THEN TO “MY PROJECTS”
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UNDER “REQUEST TYPE,” CLICK THE HYPERLINK
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PI RESPONSE FORM
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SCROLL DOWN TO REVIEW PROVISOS
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SCROLL DOWN TO REVISE APPLICATION& CLICK ON THE GREEN BAR
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CLICK “ADD REVISION” IN ORDER TO EDIT YOUR APPLICATION
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IF YOU SEE “SAVE AND CONTINUE,” YOU CAN EDIT YOUR APPLICATION
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DON’T FORGET TO CHECK THE BOX BEFORE CLICKING “SAVE
ATTACHMENTS”!
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CHECK TO ENSURE THE NEW VERSIONSHOWS UP UNDER GREEN BAR
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CLICK ON THE GREEN BAR TO REVISE YOUR CONSENT FORM
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CLICK “ADD REVISION” IN ORDER TO EDIT YOUR CONSENT FORM
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CLICK “CHECK-OUT DOCUMENT”
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A POP-UP WINDOW WILL ASK YOU TO OPEN OR SAVE
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CLICK “SAVE”
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DON’T FORGET TO CLICK “COMPLETE CHECKOUT”
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AFTER EDITING, CLICK “CHECK-IN DOCUMENT”
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BROWSE AND SAVE YOUR EDITED CONSENT FORM
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DON’T FORGET TO CHECK THE BOX BEFORE CLICKING “SAVE
ATTACHMENTS”!
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CHECK TO ENSURE THE NEW VERSIONSHOWS UP UNDER GREEN BAR
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ANSWER THE 3 QUESTIONS IN THE PI RESPONSE FORM BEFORE SAVING & ROUTING
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I HAVE RECEIVED APPROVAL!YOU CAN FIND YOUR LETTER IN “PROJECT
CORRESPONDENCE” OR “SUBMISSIONS HISTORY”
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YOUR LETTER IN “PROJECT CORRESPONDENCE”
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YOUR LETTER IN “SUBMISSIONS HISTORY”
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CLICK ON “ADD NEW FORM” TO CREATE A FORM 2 FOR REVISION
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SCREEN 1 OF THE FORM 2 - JUST ANSWER AND CLICK “SAVE AND CONTINUE”
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THINGS TO REMEMBER AFTER SUBMITTING AN APPLICATION TO THE IRB
• Form 1 (new application): Gently remind your investigators and department chairs to sign off.
• Don’t forget to save all the way through the routing pages.
• Check your workflow tracking to make sure the IRB received your submission.
• If you have questions, look up your analyst and call her.
• Provisos can be found in your letter (project correspondence or submissions history) or in the PI Response form.
• You/your sponsor can disagree with a proviso; call and let’s talk about it!
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THINGS TO REMEMBER AFTER SUBMITTING AN APPLICATION TO THE IRB
• In your PI Response form, remember to check the box to the left of your revised application and consent form before you save that page.
• Visit our website: Getting Started page, iMedRIS guides, FAQs, policies, and more!
• Check the deadline schedule for full Board submissions - submit 3 weeks in advance.
• In general, a full Board submission will be returned to you with recommendations about 1 ½ weeks before the meeting.
• Exempt applications: expect a response in 5-7 business days.
• Expedited applications: expect a response within 2 weeks.
• All correspondence from iMedRIS goes directly to your UT email address!
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THINGS TO REMEMBER ONCE YOUR APPLICATION HAS BEEN APPROVED
• ANY CHANGE (even minor) to your study must be reviewed and approved by the IRB before the change is implemented.
• Remember to submit adverse events and major protocol deviations to the IRB for review.
• If your study is expedited or full Board (check your IRB #), you must submit a continuation/renewal form (Form 3) every year, 3 weeks before your expiration date.
• You cannot enroll above the number of subjects approved for your study - a subject is considered enrolled after signing a consent form, even if they drop out or do not pass screening tests.
• The consent form must be signed by the PI within 72 hours of the subject and person obtaining consent signing it.