SCORE Study Coordinators Organization for Research & Education - PowerPoint PPT Presentation

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