Tag: guidance
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OCR Guidance for Creating Short Study Title
Due to database restrictions and the need for consistency among databases and departments, the Emory Office for Clinical Research (OCR) has developed guidance in creating the Short Study Title. The Databases used to determine this guidance: OnCore, EPIC, Vestigo, ClinicalTrials.gov, Salesforce Study log, and eIRB submission. The Short Study Title should be based upon the…
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OSP Update: GA Department of Public Health Indirect Cost Rate Policy
The Georgia Department of Public Health has confirmed that the recovery of indirect costs is capped at 11.5%. To the extent federal funding is involved, we may collect indirect costs in accordance with our federally negotiated rate agreement, unless the federal agency has imposed limitations on F&A recovery. Accordingly, any budget routed to OSP and…
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Important IRB Updates
We have updated Data and Safety Monitoring guidance for Investigator-Initiated studies that are more than minimal risk. It is posted here under “DSMP, Site Monitoring, and DSMB Guidance,” under “Related Guidance.” Please note that some high-complexity studies do require external/independent monitoring, so please consult with the IRB, and/or Margaret Huber in the Office of Research…
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Updated Guidance on Biosketch/Other Support Implementation
*Catch up on the Thursdays at Three (T@3) webinar addressing changes to the NIH Biosketch and Other Support here May 7, 2021 Dear Colleagues, We are writing to provide you the most up-to-date information on the transition to new formats for NIH Biosketches and Other Support pages. According to the most recent issue of the…
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IRB Updates
We updated out COVID-19 guidance to include links to FDA guidance re: acceptable consent methods for participants in isolation. We also made various minor updates throughout. Important updated External IRB guidelines on what to submit to Emory IRB at time of continuing review and after major reportable events. Guidelines to avoid delay when submitting study…
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Returning to Laboratory Research at Lower Density
The Environmental Health and Safety Office (EHSO) and the Office of Research Administration (ORA) in concert with Emory Executive Leadership have developed requirements and guidance for the Phased Return of Research to Campus. As stated in the guidance communicated by Emory’s Executive Leadership on Friday, May 15th, EHSO has developed a mandatory training course that…
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Returning to Laboratory Research at Lower Density
The Environmental Health and Safety Office (EHSO) and the Office of Research Administration (ORA) in concert with Emory Executive Leadership have developed requirements and guidance for the Phased Return of Research to Campus. As stated in the guidance communicated by Emory’s Executive Leadership on Friday, May 15th, EHSO has developed a mandatory training course that…