Author: Ashley Myers
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Implementation of New eDisclose System
eDisclose is a new cloud-based enterprise-wide system for disclosing financial interests and requesting approval for external activities. eDisclose will replace eCOI and go live in Summer 2022. eDisclose offers an improved user experience, will streamline enterprise-wide processes, and enable compliance with new U.S. government regulatory requirements. Please visit the eDisclose SharePoint site for more information. You…
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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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IACUC Office Updates- December 2021
Submission deadlines: December is a short month, please submit your renewals and updates early. The IACUC Committee meets on the 1st and 3rd Wednesdays of the Month. Deadlines for FCR review are 4PM on the Wednesday one week PRIOR to the meeting date for the agenda to be disseminated to members. DMR reviews are rolling submissions…
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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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Important IRB Updates
We have updated Data and Safety Monitoring guidance for Investigator-Initiated studies that are more than minimal risk. It is posted here under “DSMP, Site Monitoring, and DSMB Guidance,” under “Related Guidance.” Please note that some high-complexity studies do require external/independent monitoring, so please consult with the IRB, and/or Margaret Huber in the Office of Research…
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Valuable Research IT Tools Become Available to All Labs
When Dr. Bruner, Senior Vice President of Research, commissioned the Research IT Task Force in 2019, one of the group’s recommendations was to lower the cost barrier of IT solutions. As a result, we are excited to announce enterprise availability for the REDCap and OpenSpecimen platforms. All research teams will soon be able to utilize…
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Award Closeout Policy Update
On September 1, 2021, we launched four new/updated policies related to award close outs. These polices were developed in collaboration with RAS leaders, CBOs, and ORA leaders. They were designed to ensure sponsored awards are closed out promptly in COMPASS. This will benefit our research community by streamlining the process of award close out. These…
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FY22 Fringe Rate Announcement
*Sent on behalf of the Office of Sponsored Programs & Research Grants and Contracts* Dear Colleagues, The FY22 federal and non-federal fringe rates have now been approved. The new rates are as follows: These fringe rates become effective on September 1, 2021. All proposals to federal sponsors (or for federal flow-through) should begin using the…
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Research Administration Administrative Transitions
As we commence the school year, a number of leadership changes are underway. We have developed a framework for a smooth transition, ensuring continuous service to faculty. COI Come December, we will say goodbye to Assistant Vice President for Research Administration and Conflicts of Interest Director, Brenda Seiton, who is retiring after 25 years at…
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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…