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Internal Medicine Research Administration: November 22, 2017 Update

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Internal Medicine Research Administration: November 22, 2017 Update Internal Medicine Research Administration: November 22, 2017 Update UU Research Reproducibility Grand Rounds Tuesdays 12-1PM thru April 24, 2018 – Partial schedule below Garden Level, Synapse Bays Spencer S. Eccles Health Sciences Library This series includes weekly discussions to raise awareness about reproducibility issues, showcase Utah researchers’ work, and to create an open forum for discussion. In addition, an immersive workshop and conference is scheduled for June 2018. For more information and a complete schedule, visit the Grand Rounds: Research Reproducibility site. Schedule: November 28th – January 30th, 12:00-1:00, Eccles Health Sciences Library Nov 28 Erin Rothwell Reproducibility and Qualitative Research Dec 5 Ram Gouripeddi Reproducible Informatics for Reproducible Research Dec 12 Tom Greene Error Terms Jan 9 Bryan W Jones Peer Reviewing Images Jan 16 Mallory Kidwell Incentives to Embrace Change: Initiatives to Promote Research Reproducibility Jan 23 Willard Dere CCTS Jan 30 Rob Singleton University-wide Performance Metrics for Clinical Trials FDA Inspections: What you Need to Know if the FDA Contacts you From IM Clinical Research Compliance (SOP REG-01) The U.S. Food and Drug Administration (FDA) conducts inspections of clinical trials to ensure the rights, safety and welfare of subjects are protected, and to determine the accuracy of clinical trial data. Routine Inspections are most common, and are triggered by a New Drug Application submission by a study sponsor; generally, clinical sites with the highest enrollment are selected for inspection. For Cause Inspections are infrequent and generally arise when the FDA receives reports of deviations, subject safety, misconduct, etc. Inspection Notification and Preparation The FDA will notify the Principal Investigator (PI) of an inspection. The PI should in turn notify the sponsor, department leadership, Internal Medicine Associate Director for Clinical Research Compliance (Scott Low), and the Office of General Counsel. With assistance from study coordinators and the IM Associate Director for Clinical Research Compliance, the PI should review study documentation and records in preparation for the inspection, including screening/enrollment logs, delegation logs, training records, informed consent forms, patient research charts, case report forms and the regulatory binder. The study records should be reviewed for completeness and accuracy; any issues or deficiencies discovered during the review should be addressed and corrected as appropriate. Conduct of the Inspection FDA inspectors will present their ID/credentials and Notice of Inspection (form FDA-482) upon arrival. The inspection is primarily conducted through: questioning investigators and staff about clinical research practices and procedures, conducting a physical inspection of site facilities, and a thorough review of study documentation. Whenever possible, the PI should request a daily meeting to determine if there are outstanding issues, questions or concerns that can be addressed while the inspectors are on-site. At the conclusion of the inspection, any formal observations or findings will be provided to the PI on the Inspectional Observations form (FDA-483). The PI should ask the investigators what specific responses, actions or changes will adequately address the cited Inspectional Observations. Post-FDA Inspection The PI will work with the Office of General Counsel, the IM Associate Director for Clinical Research Compliance and other personnel as needed to draft an official written response to the Inspectional Observations. Written responses should include a root cause analysis of the observation and a measured corrective and preventative action plan (CAPA), such that further occurrences of the issue will not take place. Realistic timelines and evaluation metrics should be included for implementation and assessment of all corrective actions. The FDA inspection may be followed by an official letter (Informational Letter or Warning Letter) issued by the FDA Office of Scientific Investigations. Any outstanding problems or issues in such a letter should be promptly assessed and addressed, and a response provided to the FDA within the scope and time frame required in the official letter. Further information, guidance and examples can be found in this Internal Medicine Research Administration SOP, which is located on the Pulse web site: https://pulse.utah.edu/site/internal-medicine/Documents/Forms/ResearchAdmin.aspx Questions: Scott J. Low, MBA; IM Associate Director for Research Compliance; [email protected] From the AAMC 11/10/17 PNAS Opinion: The Next Generation Researchers Initiative at NIH A PNAS article by NIH Deputy Director Mike Lauer, PhD, Principal Deputy Director Lawrence Tabak, DDS, PhD, and Director Francis Collins, MD, PhD, discusses the NIH's Next Generation Researchers Initiative, which aims to redistribute funding to reverse trends in the current hypercompetitive environment that lead to an aging biomedical workforce. To do this, the NIH plans to fund 200 more early-career and 200 more mid-career scientists in FY 2017 than were funded in FY 2016. This policy will result in funding for 2,000 additional early- and mid-career scientists who would have otherwise been just under the payline for research project grants. The NIH has also established a Working Group of the Advisory Committee to the NIH Director to explore new productivity measures for more equitable funding distribution. In the near term, money may be redistributed from "recent Congressional budget increases, from lower allocations to institute-initiated research programs, from selected decisions to reduce increments in funding for investigators who are already well funded, and from greater allocations to certain targeted programs." NIH FUNDING OPPORTUNITIES For all active NIH funding opportunity announcements (FOAs), please visit: NIH Funding Opportunities. ARCHIVED RESEARCH ADMINISTRATION UPDATES Past and present updates are published online here for quick reference. IM RESEARCH ADMINISTRATION CONTACTS Chris LaSalle Director [email protected] 585-2734 Scott Low Associate Director, [email protected] 585-1380 Clinical Research Compliance Jennifer Hammond Research Manager [email protected] 581-6526 Ashley Kapron Special Projects Manager [email protected] 585-2084 Kris Larrabee Grants and Contracts Manager [email protected] 585-7655 Jessica Little Research Manager [email protected] 581-3694 Heather Parkin Senior Grants and Contracts Officer [email protected] 585-7090 Mary Jane Tinnes Clinical Research Coordinator [email protected] 585-2254 Sally Bradstreet Clinical Research Coordinator [email protected] 581-4684 .
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