Category: OCR
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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.
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OCR September 2013 Announcements, Course, and Event Calendar
The Office for Clinical Research is pleased to announce its professional development opportunities, as well as three new job opportunities in the central office. Please click the image below to review in the browser.
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ERMS Research Billing Forms Eliminated
ERMS Billing Forms will be eliminated as of September 1, 2013. The policy can be found on OCR’s website at: http://www.ocr.emory.edu/policies/index.html. Please remember, it is still important for you to complete the following: On-study your subjects in ERMS and send the consent and fax cover sheet to OCR on the same day the…