Tag: compliance
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Emory’s Award Closeout Plan and Roadmap
Author: Patrick Amihere, Associate Director of Closeout, RGC In recent years, our institution has had significant challenges to ensure proper, timely, and effective award closeouts for all sponsored awards, therefore, it is not a surprise that the immediate improvement of an effective award closeout business process is the university’s No. 1 priority. These improvements also…
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Message from VPRA, Dr. Robert Nobles (March 2024)
Greetings and welcome to Spring! As many of you are returning or anticipating a Spring break, I hope that the time you take allows you to rest, reflect and rejuvenate for a strong finish to the academic year. As I look at your phenomenal efforts and the progress we’ve made as an institution in research…
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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,…