Using A Central IRB At Thomas Jefferson University / Hospital Roseann Talarico Associate Director Office…
out of 7
Post on 20-Jan-2018
DESCRIPTIONComplete ePTF and notify ORA of intention to join a study approved by Quorum or WIRB Follow the standard process for creating a new study record in JeffTrial
<p>Using A Central IRB</p> <p>At Thomas Jefferson University / Hospital</p> <p>Roseann Talarico</p> <p>Associate Director</p> <p>Office of Human Research</p> <p>Joining an Existing Study with Quorum and WIRB Review IRB</p> <p>Complete ePTF and notify ORA of intention to join a study approved by Quorum or WIRB</p> <p>Follow the standard process for creating a new study record in JeffTrial</p> <p>In the Portal, at the Create an IRB Application drop-down menu, select Quorum or WIRB, and upload an OHR-1. (Be sure to check off Quorum Review IRB or Western IRB (WIRB) at the top of the OHR-1.) This is the only document you will upload in the Portal. There is no paper submission.</p> <p>If OHR authorizes the submission to proceed, it will issue a signed TJU-Quorum Institutional Cover Page or WIRB Cover Page.</p> <p>Screening Criteria for Jefferson Investigators</p> <p>Applying to Commercial IRBs</p> <p>The Office of Human Research will apply the following criteria when determining whether an investigator may apply to join a study approved by a commercial IRB:</p> <p>Study is a phase 2, 3, or 4 multi-center, commercially sponsored clinical trial.PI is in good standing with institution in regards to human subjects research compliance (e.g., PI is not currently on probation for violations).PI & research staff have completed appropriate CITI training and are up to date with COI disclosures.</p> <p>4. OHR-1 includes all required signatures.</p> <p>5. PI has history of sound ethical judgment and the ability to manage clinical trials.</p> <p>PI does not have a financial COI with the sponsor of the clinical trial.Submit through JeffTrial and upload to the Portal.</p>
View more >
IRB 7.2 IRB M EMBER T RAINING Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office.
Thomas Jefferson University ?· Thomas Jefferson University ... Organic Chemistry I and II, and Physical…
Jefferson in Office Chapter 6 Section 3. Thomas Jefferson Takes Office Thomas Jefferson had a less formal style of presidency. Instead of overturning.
Thomas Jefferson University and Jefferson Health engage ... ?· using Adobe Marketing Cloud. ... people…
Thomas Jefferson University Hospital Department of Nursing ... Thomas Jefferson University Hospital Department of Nursing Orientation Module Welcome to Thomas Jefferson University Hospitals (TJUH).
Confidential Disclosure Agreements (CDA)/ Non-Disclosure Agreements (NDA) Roseann Talarico Associate Director Office of Human Research.
PHILADELPHIA UNIVERSITY + THOMAS JEFFERSON UNIVERSITY ... ?· Philadelphia University + Thomas Jefferson…
Jefferson Student Nurse Orientation Thomas Jefferson University Hospital Department of Nursing Orientation Module Welcome to Thomas Jefferson University Hospitals (TJUH).
Back & Shoulder Region Ernest F. Talarico, Jr., Ph.D. Associate Director of Medical Education Associate Professor of Anatomy & Cell Biology Course Director,
Susan Toth-Cohen, PhD, OTR/L Associate Professor & Director, Occupational Therapy Doctoral Program Jefferson College of Health Professions Thomas Jefferson.
ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office.