The Office of Compliance presents Cyber-Ween!

The Office of Compliance is hosting its Compliance Symposium on October 31, 2016 from 11:30 am to 1:00 pm.  Our guest speaker will be FBI Special Agent Michael F.D. Anaya.  Special Agent Anaya will be discussing cybersecurity.  Due to overwhelming response registration is now closed.

External Learning Opportunity

The FDA will co-sponsor a Clinical Investigator Training Course on November 7-9, 2016, in Silver Spring, MD.  In this intensive, three-day course clinical investigators will be trained by FDA medical officers and senior scientists--along with other experts--in all aspects of clinical studies: preclinical and clinical science, statistical structure of trials, ethical requirements, and regulatory considerations.  For more information click here

2016 Emory University Compliance Program Manual

The number of laws, regulations and policies that impact the multitude of activities carried out at Emory University is enormous, and keeping up with these requirements can be challenging.  Although the Office of Compliance and the Internal Audit Division are separate units with distinct operational charges, both units recognize that a strong compliance program demonstrates the commitment of the University and its employees not only to the laws that govern our activities, but also to the ethical principles at the core of the University as an institute of higher education, research, and health care.  Accordingly, the Office of Compliance and the Internal Audit Division have collaborated on creation of the Emory University Compliance Program Manual as a means of providing faculty and staff members with an overview of the University’s compliance program.  
This publication provides faculty and staff members with information about some of the major policies and regulatory requirements that govern employee activities and introduces employees to the strong ethical principles that form the basis for Emory’s mission and work.  We hope this publication will serve both as a useful overview for new employees, and a handy reference guide for current faculty and staff.   
The manual is available here

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Update on Emory Policy Changes

Emory policies on Research Misconduct, and the Guidelines for Responsible Conduct of Scholarship and Research have been updated and there is a new policy on Authorship Guidelines and Dispute Resolution.  For more information click here.

New International Assessment Questionnaire

Global Services and the Office of Compliance worked together to create an assessment tool to assist the Office of Compliance in identifying activities that require additional assessment under export control and related regulations, and to enable Global Services to provide assistance with the various administrative and business considerations (e.g., HR, travel) that international projects can involve.  More information available here.

New tutorial

A new tutorial on the use of "Dangerous Drugs" in research is available.

New Information Resource for Monitoring Sponsor-Investigator Studies

The Office of Compliance has added a section on monitoring to our FDA regulated studies FAQs page. Sponsor-investigators can find information on developing monitoring plans and tools which can be used for site monitoring here.