Tag Archives: compliance

RCRA Minimizing Administrative Burden While Maintaining Compliance

Author: Deepika Bhatia, AVP, RCRA Minimizing administrative burden in research while ensuring compliance with regulations is a critical challenge for research compliance teams. Here are a few strategies from the Emory Research Compliance & Regulatory Affairs (RCRA) team to achieve this balance:  Operationalizing streamlined processes, efficient communications to relevant stakeholders early and often, striving for an approach to […]

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AI @ Emory: Research & Beyond – Applications, Impact, and Compliance Risks

Photo credit: elenabsl – stock.adobe.com Author: Deepika Bhatia, AVP, RCRA Artificial intelligence (AI) is the simulation of human-like intelligence processes by machines, especially computer systems. AI tools have created much flurry across the globe, and the Emory research enterprise is no exception! We are excited to embrace this new technology while ensuring the Emory community is […]

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ORIC Updates: Pre-Inspection Assistance and QA/QI Help

The Office of Research Integrity and Compliance (ORIC) has two new programs to assist registrants (holder of a controlled substance or dangerous drug registration) with their compliance needs: Pre-inspection Assistance: ORIC team members can meet with you to walk you through the process of applying to the Georgia Pharmacy Board (GPB) and the Drug Enforcement […]

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IACUC Updates- Policies, eIACUC Maintenance, and Protocol Compliance

The IACUC recently approved the updates to the following Policies Adoption Policy: This document establishes policy and provides procedures for adoption of research animals from Emory University MPTP Guidelines: These guidelines recognize the scientific value of the MPTP model of parkinsonism and attempt to address the practical problems associated with the use of this agent. […]

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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 […]

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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, […]

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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 […]

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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, […]

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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 […]

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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. […]

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