SCORE Study Coordinators’ Organization for Research & Education Wednesday , September 20, 2017 3 rd Wednesday of the Month 1-hour meetings + 30 minutes for networking For questions and to subscribe to listserv contact: SCORE@urmc.rochester.edu 1
You are juggling so many things! SCORE is here to help. 2
OHSP Seminars Wed., September 27 th , 12:00-1:00 pm; 1W-304 The Times They Are A-Changin ’: An Overview of the Final Common Rule Revisions Emily Flagg, Sr. Regulatory Specialist, RSRB. Wed., October 25 th , 12:00-1:00 pm; 1W-304 ICH GCP E6 R2 – Changes? Yes. Challenges? Not as Difficult as You May Fear Lorrie D. Divers, President, QRCP Solutions, Inc. Visit the OHSP website 3
Training Opportunities for New Coordinators Self-enroll in the OHSP training through MyPath • Orientation to Conducting Human Subject Research • Research Boot Camp • Core Training Visit the OHSP website 4
NYS SoCRA Chapter Fall Program Friday, November 3, 2017 8:00 am – 3:00 pm Skaneateles Falls, NY • The program is approved for 5 CEUs for SoCRA members • Certificates of Attendance for non-SoCRA attendees will be provided • For details, contact SCORE 5
Today’s Resource Tip : First Clinical Research – this online resource provides information on clinical research best practices to support sponsors, sites and other agencies operate more effectively and efficiently and contains: • Journal of Clinical Research Best Practices over 1,200 online articles • Searchable database over 600 laws, regulations and guidelines • Searchable database over 7,000 FDA GCP Q&As 6
CTSI Weekly Update Do you have an item you would like to publicize in the CTSI Weekly Update or Calendar? Contact Katie Crane: Kathleen_Crane@urmc.rochester.edu. The CTSI Weekly Update and Calendar are the sources for: • Events • Collaboration Opportunities • Career Development Opportunities • Funding Opportunities in Clinical and Translational Science Events from Sep 19th Look for the newsletter every Monday. 7
SCORE Website • Located on the CTSI “Connections” web page: https://www.urmc.rochester.edu/clinical- translational-science-institute.aspx • Linked on the OHSP home web page Additional Resources U of R websites Study Coordinators Organization for Research & Education 8
UR Coordinator Discussion Listserv Titled: CTSI SCORE Chat This online forum provides opportunities to chat with peer coordinators and to share resources and practices. To subscribe, email SCORE. 9
Feedback – May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects in Research What I liked best: “ Having specific examples to discuss whether email consent was needed was very helpful. ” “Case scenarios were good for discussions; he kept it light- hearted.” “ Excellent presenter, very engaging .” 10
Research Services and Resources Affiliated CTSI-Associated UR Resources: Centers: Biostatistics Comparative Effectiveness Center for Community Health Epidemiology Center for Human Experimental Human Behavior Assessment Support Provided Therapeutics Physical Exercise Activity Clinical Research Center Through the CTSI: External Kinesiology (PEAK) Lab Center for Research Implementation URMC Labs Biomedical Informatics Resources: and Translation Shared Resource Laboratories ClinicalTrials.gov Registration Peer Institutions Scientific Writing Services Education and Training • UNYTE eRecord for Research • CTSAs FDA Regulatory Compliance Government Agencies Mentoring Contract Research Organizations Research Ethics Others Identified to meet needs Research Methods Forum Trial Innovation Centers Pilot and Incubator Funding Recruitment Innovation Center Research Help Desk ResearchHelp@urmc.rochester.edu
New HIPAA Privacy Officer for Research Kathleen Tranelli Kathleen_Tranelli@URMC.Rochester.edu 585-784-6154 12
Today’s Open Discussion ResearchMatch.org – Creating Effective Subject Contact Messages Presented by: Nancy A. Needler BS CCRC CTSI, Manager, Research Coordinator Program ePARC/Epic – Changes Affecting Research Coordinators Facilitated by: Mike Ritz, ORPA, Research Compliance Officer Presentation materials will be available on the SCORE website 13
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