Category Archives: OCR

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 Pre-Notice & Notice of Noncompliance

The Food and Drug Administration (FDA) is taking action to ensure certain information in 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

  Click here to learn about the new requirements for  

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

New FDA regulation and NIH policy

Written by: Jennifer Prozonic Office for Clinical Research  Changes and Impact of FDA Final Rule & NIH Policy for In September of 2016, the U.S. Department of Health and Human Services issued a final rule expanding the scope of 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 Written By: Bridget Strong Office for Clinical Research

Also posted in Announcements, ORA | Comments closed

New Saint Joseph’s Hospital (ESJH) Clinical Trials Policy

On October 6, 2015, Emory’s Clinical Trials Operations Committee approved a new policy to guide EU faculty and EHC-employed physicians/staff with information on conducting clinical trials/research or diagnostic services for research purposes at an ESJH site. Read More>>

Posted in OCR | Comments closed