Category: ORA
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GBP Requires License Renewal by June 30, 2016 for Animal Research Using Controlled Substances and Dangerous Drugs
2016 is the renewal year for all persons holding a Researcher Pharmacy registration from the Georgia Board of Pharmacy (GBP Researcher). GBP Researcher registrations expire on June 30 of even numbered years. You must maintain active status of your registration to lawfully possess Dangerous Drugs or Controlled Substances obtained using this registration. Renew prior to…
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Program Updates from COI: External Investigators Engaged in Emory Sponsored Research
External investigators, who are engaged in Emory PHS -sponsored research and are following Emory’s COI policies, must complete the External Investigator Report of Financial Interests in Research Form at: Proposal submission; Annually if said investigator is engaged on the project that particular year; and Within 30 days of learning of a new financial interest related…
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Draft Version of the Proposal & Award Policies Procedures Guide (PAPPG) Available for Comments!
The National Science Foundation (NSF) has completed an updated draft of its Proposal and Award Policies and Procedures Guide (PAPPG) and posted it for review. On May 16, 2016, NSF published a notice in the Federal Register announcing the availability of and giving access to a draft of the updated Proposal & Award Policies &…
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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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Change to RAS Satisfaction Survey Process
RAS Central Operations launched faculty satisfaction surveys for pre and post award services provided by their home RAS unit in March of 2014. During the subsequent two years, surveys were distributed monthly and bi-annually for pre and post award activities, respectively. Despite numerous adjustments to the process we continue to experience multiple challenges including: low…
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2 CFR Part 200 – Uniform Guidance Online Training is LIVE!
The Office of Sponsored Programs is pleased to announce that the online training module for Uniform Guidance, 2 CFR (Code of Federal Regulations) Part 200, is available in Emory’s Learning Management System (ELMS). The training is designed to explain at a fundamental level the Code of Federal Regulations as they apply to federal awards. The…
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FY15 A-133 Audit in the books!
We recently completed our FY15 A-133 Audit covering the major programs of Research & Development (R&D) and Student Financial Aid. We received an unmodified opinion with no findings, material weaknesses, or significant deficiencies in internal controls; this is terrific news, and I want to thank everyone who played a part in helping us complete this…
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Imminent Changes to Federal Regulations
The Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule has been released! The proposed changes to the regulations will have significant impact on the conduct and oversight of human subjects research, if passed. For example, completely deidentified biospecimens may become covered by the Common Rule, and their use in research will require…
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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…