Category: OCR
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Office of Research Administration Newsletter’s New Web Address
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in Announcements, Audit, Cayuse Tips, COI, Compass, Compliance, Cost Transfer, ERAZ, IACUC, IRB, OCR, ORA, ORC, OSP, OTT, RAS, RGC, TrainingIn 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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Key Concepts in Clinical Research for Investigators
If you recently received an e-mail for the Emory Learning Management System (ELMS) to recertify for the Key Concepts in Clinical Research for Investigators course, please disregard it. You will be notified by OCR when it is time to recertify for the course. We are working with IT to modify the communications sent from ELMS…
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ClinicalTrials.Gov – New Federal Regulation for Billing
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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Upcoming Courses and Events form the Office of Clinical Research
If you are a Clinical Research Coordinator, Research Nurse, Resident, Fellow, Department or Research Administrator, or Investigator, we encourage you to sign up for one of our educational programs. We offer several programs on-line and in the classroom. For a list of courses offered by OCR for your job role, please review our web page…
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ACTSI Clinical Research Nursing Alliance
ACTSI is establishing a community of clinical research nurses. Please click the flyer below to find out more.