Category Archives: OCR

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 […]

Posted in OCR | Tagged , , , , , , | Comments closed

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 […]

Posted in OCR | Tagged , , , | Comments closed

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 | Tagged , , , , , | Comments closed

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 […]

Also posted in ORA, OSP, RAS | Tagged , , , , , , , , , , | Comments closed

New Requirements for ClinicalTrials.gov

  Click here to learn about the new requirements for ClinicalTrials.gov.  

Also posted in Announcements, Compliance, F&A, NIH, ORA Spotlight | Tagged , , , , , , , | Comments closed

New ClinicalTrials.gov FDA regulation and NIH policy

Written by: Jennifer Prozonic Office for Clinical Research  Changes and Impact of FDA Final Rule & NIH Policy for ClinicalTrials.gov In September of 2016, the U.S. Department of Health and Human Services issued a final rule expanding the scope of ClinicalTrials.gov and requiring additional registration and results reporting requirements to the existing Food and Drug […]

Posted in OCR | Tagged , , | Comments closed

Changes to Clinical Research Training

You may have received a letter from Dr. Jeffrey Lennox, summarizing changes to the required training for researchers working on clinical trials. That training is now partially conducted via CITI, the same site that provides our IRB-required ethics training. However, until further notice, the IRB will still require your proof of completion to be uploaded […]

Also posted in Compliance, IRB | Tagged , | Comments closed

Updated Clinical Trials Consent Template

The Emory Biomedical, Grady, Children’s Healthcare of Atlanta, and Saint Joseph’s Hospital of Atlanta Consent/HIPAA templates have been updated. The new version date for all documents is 4-15-2016. Changes to the template include: A clarification to the guidance comments regarding medical records, Additional language for Cost Option 1 regarding what subjects may be liable for […]

Also posted in IRB, ORA, OSP, OTT | Comments closed

New ERMS Feature

Effective 12/01/2015, a new feature was implemented in ERMS to allow study teams to track non-subject activities such as IRB fees, pharmacy fees, equipment, materials, record retention, dry ice, etc.  The new tracking feature in ERMS will appear under the Study tab as Non-Subject Activity.  For instructions, review the ERMS User Guide. Written By: Bridget […]

Also posted in Announcements, ORA | Comments closed

Interested in volunteering for a clinical trial?

Emory Healthcare Initiatives implemented a new website that includes the clinical trials being conducting at Emory for potential volunteers.  To learn more about clinical trials at Emory or if you are interested in volunteering for a clinical trial, review the Clinical Trials at Emory website at http://clinicaltrials.emory.edu/index.html. Written By: Bridget Strong Office for Clinical Research

Also posted in Announcements, ORA | Comments closed