Category: ECRO
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New Department: Emory Clinical Research Office (ECRO)
Effective June 1, 2025, OCR and WISC have combined to streamline and simplify research operations at Emory. The newly formed department is now known as the Emory Clinical Research Office (ECRO) and is led by R. Donald Harvey, Vice President for Clinical Research, and Robin Ginn, Associate Vice President for Clinical Research, under the Woodruff…
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Courtesy Review for Your Initial Protocol or Amendment
Protocols, and their amendments, frequently involve billables and require careful attention to ensure proper documentation, communication, and adherence to relevant regulations and policies. These changes can impact the budget, funding, and overall study design, and may require a Coverage Analysis (CA). A Coverage Analysis is a process of determining how each billable item and service…
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Support for Developing Your Prospective Research Budget
Many investigators seek industry or foundation funding to support their research concepts. As part of the funding application process, a prospective budget is required. This budget serves as a financial blueprint, providing a detailed estimate of all costs necessary to conduct the proposed research—including both direct and indirect expenses. The Office for Clinical Research (OCR)…
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OCR Guidance for Creating Short Study Title
Due to database restrictions and the need for consistency among databases and departments, the Emory Office for Clinical Research (OCR) has developed guidance in creating the Short Study Title. The Databases used to determine this guidance: OnCore, EPIC, Vestigo, ClinicalTrials.gov, Salesforce Study log, and eIRB submission. The Short Study Title should be based upon the…
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OnCore Training and SharePoint Updates
As part of Emory Healthcare transitioning to the Epic electronic medical record and billing system, the University will be concurrently implementing the OnCore Clinical Trials Management System (CTMS) to provide a seamless connection for clinical research across the enterprise. OnCore is a cloud-based CTMS designed to simplify the management of clinical research and integration of…
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Clinical Trials and the Advantage of a Feasibility Assessment
In the Spring of 2019, the Emory University Office of the Senior Vice President for Research contracted with Huron Consulting Group to produce an analysis that examined business processes across the life cycle of a grant. The subsequent results of the analysis reported: “Clinical trials are not consistently required to go through a formal feasibility…
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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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Rapid Response Expedites COVID-19 Related Studies at Emory
In January 2020, the Georgia CTSA Quality & Efficiency program finalized their SOP for the Rapid Response Team to obtain fast-track approvals across the Emory system. This new SOP allows for the coordination of needed approvals within 48 hours. The process was a collaboration, with Office for Clinical Research (OCR) leading Emory’s Rapid Response Team…
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New Requirements for ClinicalTrials.gov
Click here to learn about the new requirements for ClinicalTrials.gov.