Category Archives: OCR

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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OCR’s Education and Outreach Team Receives ATD’s 2014 Champion of Learning Award!

The Office for Clinical Research Education and Outreach team won the 2014 American Society for Training and Development (now Association for Talent Development) Champion of Learning Award on behalf of Emory University.  The award recognizes individuals whose advocacy, commitment, or actions in support of learning and talent development have influenced audiences or organizations. The award’s […]

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Know Your Contract Status – Use eCTS

The Emory Contracts Tracking System (eCTS) is an electronic contract management and tracking system that allows Emory faculty and staff to track the status of agreements from initial receipt to full execution, as well as the ability to obtain additional information pertaining to specific incoming agreements.  The system is web-based, allowing Emory faculty and staff to […]

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Office of Research Administration Newsletter’s New Web Address

In 2013 the Office of Research Administration Newsletter was transitioned to an online format using one of Emory’s web tools.  This year, we were asked to move our newsletter to a new institutional tool.  This task is complete.  The July/August 2014 edition of Emory’s Research Administration Newsletter is available at:  https://scholarblogs.emory.edu/ranews.  Please update any bookmarks […]

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Reminders From the Office of Conflict of Interest – August 2014

  The following are reminders from the Office of Conflict of Interest. All research projects, including clinical trials and internally funded research, require annual financial interest disclosures to be completed by investigators, including No- Cost Extensions.   Staff must initiate a new Proposal Financial Interest in Research Report each year of the project in the eCOI […]

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Appropriate Training and Qualifications in Clinical Research

The Office for Clinical Research offers several training programs in clinical research to ensure good clinical practice at Emory.  Our programs are developed based on job roles and responsibilities with a focus on compliance. Recently, the Declaration of Helsinki was revised in 2013 to state “medical research must be conducted by individuals with appropriate training […]

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Research Matters Presentation Available

February’s Research Matters presentation is available for review at http://ocr.emory.edu/training/seminars.html.  If you attended, please complete our survey at https://www.surveymonkey.com/s/38FSP9L. Information about the next Research Matters event will be shared soon via our listserv. To receive this communication, please subscribe to our listserv on our website at www.ocr.emory.edu.  

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Should Your Research Be Registered on ClinicalTrials.Gov?

If a research study meets any one of the following definitions, the trial must be registered on ClinicalTrials.gov: The Food and Drug Administration (FDA) requires registration for “applicable clinical trials” (ACTs) defined as follows: For any trials of drugs and biologics:  controlled clinical investigations, other than Phase I investigations, of a product subject to FDA […]

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OCR Announcment – ClinicalTrials.Gov

There is a new federal regulation for billing Medicare recipients participating in clinical trials.  As of January 1, 2014, the clinicaltrials.gov number (NCT#) assigned to the study must be listed on Medicare claims for services provided to clinical trial participants.  If the number is not listed on the claim, payment will be denied. In order […]

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