Electronic Submission to the Jefferson IRB Using the Portal Kyle Conner, MA, CIP Associate Director Office of Human Research

The Office of Human Research (OHR) Walter Kraft, MD Director, Office of Human Research (215) 503-0203 Walter.Kraft@jefferson.edu Kyle Conner, MA, CIP Associate Director, Office of Human Research (215) 503-8966 Kyle.Conner@jefferson.edu OHR Homepage –http://www.jefferson.edu/university/human_research.html

OHR Resources and Quick Links: IRB submission flow diagram - http://www.jefferson.edu/content/dam/tju/human_research/irb/documents/HowtosubmittoIRB/IRB%20Submission%20Flow%20Diagram.pdf Overview of IRB submissions for new studies - http://www.jefferson.edu/content/dam/tju/human_research/irb/forms/Overview%20of%20IRB%20Submissions%20for%20New%20Studies%20Jul%208%202015.pdf IRB Submission Portal User Manual - https://black.kcc.tju.edu/legacytrialapps/esubmission/docs/Coordinator%20Training%20Document%20-%20The%20Portal%20v.%201.1.pdf JeffTrial Training Document - http://www.jefferson.edu/content/dam/tju/human_research/irb/documents/JeffTrial/OHR_Training_Document-Regulatory_Coordinators.pdf

Submitting to the Jefferson IRB is a dual electronic process of creating a record in JeffTrial and uploading the documents to the Portal. (Note that for submissions requiring full board review, 6 hard copies of the submission must be delivered to the OHR. Expedited and exempt submissions are completely paperless.) What follows is a brief overview of submitting in the Portal. For a detailed explanation, please consult the Training Manual, “How To Submit to the Portal,” available on the Portal menu page.

First, go to the IRB homepage and log-in to the Portal First, go to the IRB homepage and log-in to the Portal. You must either be on a computer that is on the Jefferson intranet, or you must access the Portal via the Hospital’s remote access portal (RAP).

Once you have logged into the Portal, go to “Create an IRB Application” and choose the type of transaction you want to to submit.

You will then need to enter either the JeffTrial ID# or the IRB control #.

The Portal will then identify your study (assuming you have a JeffTrial record), and you can proceed to upload the documents that comprise your submission.

Load each document with the Browse function.

You can return to the submission later or submit by clicking one of the buttons at the bottom of the page.

Once you have submitted the transaction, you will receive an email confirming this. You will receive another email stating that the transaction has been scheduled for review, and a final email indicating that the transaction has been reviewed. You must await a formal approval letter before you can initiate the study, continuing review, or amendment that you submitted. All approvals are emailed to the person identified as the IRB contact by an IRB secretary.

Questions?