Tag Archives: compliance

ClinicalTrials.gov Pre-Notice & Notice of Noncompliance

The Food and Drug Administration (FDA) is taking action to ensure certain information in ClinicalTrials.gov is available to the public. On April 28, 2021, the FDA issued its first notice of non-compliance for failing to submit required results information. A Notice of Noncompliance indicates that the FDA has determined the Responsible Party (Principal Investigator) was […]

Posted in OCR | Also tagged , , , , | Comments closed

Restructuring and Establishment of the New Research Compliance Office

On January 25, 2021, an announcement was released from the EVP for Business and Administration, Christopher Augostini, regarding the restructuring of the University Compliance Office and the establishment of a new Research Compliance Office.  The announcement in its entirety, can be found here. After the retirement of the former leader of the Office of Compliance, […]

Posted in Compliance, ORA | Also tagged , , , | Comments closed

Featured BioRAFT Functionality – How to Add Personnel

This month EHSO will provide you with a few tips that may help you navigate the electronic platform to manage personnel using biological, chemicals and radioactive materials in your laboratory. Addition of research individuals to the Principal Investigator’s registration in BioRAFT will allow them to complete training. Only Emory staff and Emory students who appear […]

Posted in EHSO | Also tagged , , , , , , , , , | Leave a comment

How to Prepare for Lab Moves and Close-Outs

Is your lab moving? Is your lab relocating to a new space? Is your lab closing-out and stopping research activities? If you answered YES to any of these questions, contact your EHSO Building Liaison. We are here to help make the transition smooth and easy. EHSO has recently updated the guidelines for Lab Moves, Relocations, […]

Posted in EHSO | Also tagged , , , , , , , , , | 1 Comment

DEA Controlled Substances and Dangerous Drugs

Updates Regarding Controlled Substances and Dangerous Drugs: The Office of Compliance has updated its Controlled Substances and Dangerous Drugs forms (available here). In addition to the updated forms, a new Self-Inspection Form and a new Controlled Substance Dilution Use Log are now available. The Office of Compliance FAQ document “State of Georgia and Federal Law […]

Posted in EHSO | Also tagged , , , , , , , , , | Leave a comment

The 3 C’s of Chemical Waste Management

April is Environmental Month. The EHSO Environmental Compliance Group assists Emory University investigators in compliancing with applicable United States Environmental Protection Agency (U.S. EPA) regulations. These regulations were developed to protect our natural resources. EHSO provides guidance on chemical waste disposal to ensure that our natural resources are protected and that Emory maintains regulatory compliance. […]

Posted in EHSO | Also tagged , , , , , , , , | Comments closed