i just submitted to the irb… what now?

41
I JUST SUBMITTED TO THE IRB… WHAT NOW?

Upload: trory

Post on 24-Feb-2016

64 views

Category:

Documents


0 download

DESCRIPTION

I just Submitted to the IRB… What now?. Have I really submitted it?? (Not in this case - Click the yellow box). Click on the Routing Assignment list icon. You have not clicked “Save and Continue” to begin routing. Signatures are still needed: “Waiting for PI signoff”. - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: I just Submitted to the IRB… What now?

I JUST SUBMITTED TO THE IRB… WHAT NOW?

Page 2: I just Submitted to the IRB… What now?

HAVE I REALLY SUBMITTED IT??(NOT IN THIS CASE - CLICK THE YELLOW BOX)

Page 3: I just Submitted to the IRB… What now?

CLICK ON THE ROUTING ASSIGNMENT LIST ICON

Page 4: I just Submitted to the IRB… What now?

YOU HAVE NOT CLICKED “SAVE AND CONTINUE” TO BEGIN ROUTING

Page 5: I just Submitted to the IRB… What now?

SIGNATURES ARE STILL NEEDED:“WAITING FOR PI SIGNOFF”

Page 6: I just Submitted to the IRB… What now?

SIGNATURES ARE STILL NEEDED:“IN PROCESS” VS. “COMPLETED”

Page 7: I just Submitted to the IRB… What now?

CHECK TO SEE WHETHER THE IRB HAS RECEIVED IT

Page 8: I just Submitted to the IRB… What now?

YES! I DID IT!

Page 9: I just Submitted to the IRB… What now?

AFTER AN IRB ANALYST IS ASSIGNED,HOW DO I TRACK IT?

Page 10: I just Submitted to the IRB… What now?

CLICK “TRACK LOCATION”

Page 11: I just Submitted to the IRB… What now?

OK, THIS IS WHOM I SHOULD CALL WITH QUESTIONS.

Page 12: I just Submitted to the IRB… What now?

REVIEWERS HAVE COMPLETED THEIR REVIEWS

Page 13: I just Submitted to the IRB… What now?

I NEED TO RESPOND TO THE IRB!CLICK TO OPEN FROM YOUR “INCOMPLETE TASKS”

Page 14: I just Submitted to the IRB… What now?

OR: GO TO “PROJECT ASSISTANT,” THEN TO “MY PROJECTS”

Page 15: I just Submitted to the IRB… What now?

UNDER “REQUEST TYPE,” CLICK THE HYPERLINK

Page 16: I just Submitted to the IRB… What now?

PI RESPONSE FORM

Page 17: I just Submitted to the IRB… What now?

SCROLL DOWN TO REVIEW PROVISOS

Page 18: I just Submitted to the IRB… What now?

SCROLL DOWN TO REVISE APPLICATION& CLICK ON THE GREEN BAR

Page 19: I just Submitted to the IRB… What now?

CLICK “ADD REVISION” IN ORDER TO EDIT YOUR APPLICATION

Page 20: I just Submitted to the IRB… What now?

IF YOU SEE “SAVE AND CONTINUE,” YOU CAN EDIT YOUR APPLICATION

Page 21: I just Submitted to the IRB… What now?

DON’T FORGET TO CHECK THE BOX BEFORE CLICKING “SAVE

ATTACHMENTS”!

Page 22: I just Submitted to the IRB… What now?

CHECK TO ENSURE THE NEW VERSIONSHOWS UP UNDER GREEN BAR

Page 23: I just Submitted to the IRB… What now?

CLICK ON THE GREEN BAR TO REVISE YOUR CONSENT FORM

Page 24: I just Submitted to the IRB… What now?

CLICK “ADD REVISION” IN ORDER TO EDIT YOUR CONSENT FORM

Page 25: I just Submitted to the IRB… What now?

CLICK “CHECK-OUT DOCUMENT”

Page 26: I just Submitted to the IRB… What now?

A POP-UP WINDOW WILL ASK YOU TO OPEN OR SAVE

Page 27: I just Submitted to the IRB… What now?

CLICK “SAVE”

Page 28: I just Submitted to the IRB… What now?

DON’T FORGET TO CLICK “COMPLETE CHECKOUT”

Page 29: I just Submitted to the IRB… What now?

AFTER EDITING, CLICK “CHECK-IN DOCUMENT”

Page 30: I just Submitted to the IRB… What now?

BROWSE AND SAVE YOUR EDITED CONSENT FORM

Page 31: I just Submitted to the IRB… What now?

DON’T FORGET TO CHECK THE BOX BEFORE CLICKING “SAVE

ATTACHMENTS”!

Page 32: I just Submitted to the IRB… What now?

CHECK TO ENSURE THE NEW VERSIONSHOWS UP UNDER GREEN BAR

Page 33: I just Submitted to the IRB… What now?

ANSWER THE 3 QUESTIONS IN THE PI RESPONSE FORM BEFORE SAVING & ROUTING

Page 34: I just Submitted to the IRB… What now?

I HAVE RECEIVED APPROVAL!YOU CAN FIND YOUR LETTER IN “PROJECT

CORRESPONDENCE” OR “SUBMISSIONS HISTORY”

Page 35: I just Submitted to the IRB… What now?

YOUR LETTER IN “PROJECT CORRESPONDENCE”

Page 36: I just Submitted to the IRB… What now?

YOUR LETTER IN “SUBMISSIONS HISTORY”

Page 37: I just Submitted to the IRB… What now?

CLICK ON “ADD NEW FORM” TO CREATE A FORM 2 FOR REVISION

Page 38: I just Submitted to the IRB… What now?

SCREEN 1 OF THE FORM 2 - JUST ANSWER AND CLICK “SAVE AND CONTINUE”

Page 39: I just Submitted to the IRB… What now?

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!

Page 40: I just Submitted to the IRB… What now?

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!

Page 41: I just Submitted to the IRB… What now?

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.