PPT-How to submit an amendment to a project that has already received IRB approval

Submitting an Amendment Step 1 Log into IRBManagerDashboard On your dashboard click on the hyperlink of the study you want to amendmodify The studys home page will appear Step 2 Find Events Section of Project Home Page. brPage 1br Bill of Rights brPage 2br Amendment Amendment 11 Amendment 111 Amendment brPage 3br Amendment V Amendment V Amendment V 11 Amendment V 111 Amendment Amendment SLSQ v12-8-11. What is ‘IRB Awareness’ . Many of our Bronze Medallion members are asked to assist with the manual handling and set up/pack down of IRBs when on . patrol. It is important that these members know how to operate safely around IRB equipment if/when asked to help by the IRB . . Mechanics: Looking under the hood. IRB Administrators 2012. PRIDE. Lucindia Shouse, MS, CIP. May 31, 2012. Road Map. Question-and-Answer Session. Traveling to and fro (basic, beyond and in between). Agenda. GRU IRB Development and Changes. WIRB-Copernicus Group. Process for transfer of Chesapeake IRB protocols. Process for the new WIRB submissions. GRU IRB Development and Changes. WIRB and IRBNet. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality Assurance. Criteria for IRB Approval (111 Findings). 2. Risks . to . research participants are . minimized; . Risks . A How-To Guide. http://www.uthsc.edu/research/research_compliance/IRB. /. (901) 448-4824. irb@uthsc.edu. UTHSC Institutional Review . Board (IRB). Charged with protecting human research subjects. Ensures compliance with the federal regulations (DHHS, FDA, & HIPAA) with regards to research applications, consent forms and other research materials to be used; and with regards to the conduct of the research itself. May 19, 2017. Topics. Drivers for Centralized IRB Review. Regulatory changes . Trial Innovation Network. How JHM IRB will address the Single IRB requirements . Key Decisions. When JHM is serving as the IRB of Record. . Objectives. Why are renewals necessary?. What projects require a renewal?. How do I find the form?. How do I . fill . out the form. ?. What are the required documents with submission?. When do I submit the renewal?. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality Assurance. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. . Objectives. What is an amendment?. What projects are required to submit an amendment?. How do I find the form?. How do I . fill . out the form. ?. What are the required documents with submission?. 2. AURA-IRB Trainer. Candace Washington. cdwashington@uchicago.edu. 2-2925. Your Name. Department. If you could be any . . Rockstar. . who would it be???. Our OVERALL Purpose for today!. 3. Amy Krenzer, CIP, IRB Coordinator. Hila Berger, MPH, CIP, Research compliance Officer. 1. Objectives . What is the Institutional Review Board (IRB) responsible for? And why?. What is Human subjects research?. USAID Takamol Jordan Gender Program(AID-278-A-14-00001)This Information Package is made possible by the support of the American people through the Takamol Program implemented by with nancing fr Best book to win online dice