Category Archives: OCR

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 […]

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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 […]

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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 […]

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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 […]

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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

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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>>

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What are the Responsibilities of a PI on a Sponsored Award?

Written By: Kerry Peluso, AVP Office of Research Administration The Principal Investigator (PI) of an award is responsible for oversight and direction of the sponsored project including both the technical and the administrative/financial aspects of the award. Section 2.1.2 of the current NIH Grants Policy Statement describes this in further detail: Program Director/Principal Investigator. A […]

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OCR Submission Form for Assessing the OCR Fee

OCR is now requesting a discretionary account on the OCR submission form for assessing the OCR fee.   The new OCR Submission Form is available on the OCR’s Forms webpage at http://ocr.emory.edu/forms/index.html > OCR Submission. If a study’s SK is issued within 2 months of OCR study completion, it will be assessed the OCR fee. […]

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Uniform Guidance: New Information Brings Some Good News and More Questions…

Uniform Guidance:  New Information Brings Some Good News and More Questions… Over the past month, additional information regarding the implementation of Uniform Guidance has been provided (verbally) by federal representatives at the FDP (Federal Demonstration Partnership) Meeting.  While some information shared was very positive, other information adds complexity to how we will need to administer […]

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National Science Foundation (NSF) Updates the Proposal and Award Policies and Procedures Guides (PAPPG)

The National Science Foundation has recently updated their Proposal and Award Policies and Procedures Guide (PAPPG). Many of the changes made in the PAPPG are related to the issuance of the new Uniform Guidance (2 CFR § 200) and references within the Guide have been updated to reflect the new Uniform Guidance rather than the […]

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