Pediatric Educ Ation Research Lunch Series PEARLS Overview

Pediatric Educ. Ation Research Lunch Series (PEARLS) Overview of Pediatric Clinical Research Resources April 8, 2016

Objectives • Understand the purpose of PEARLS • Identify key contacts from pediatric clinical research • Discuss educational and training opportunities • Review resources on pedsresearch. org Children’s Healthcare of Atlanta | Emory University 2

Panelists and Agenda • Terrell Faircloth, Clinical Research Educator, CHOA – Introductions and description of PEARLS • Stephanie Meisner, RN, BSN, CCRP, Clinical Research Manager, PRC, CHOA – Discuss ACTSI resources • Amanda Cook, Director of Clinical Research Services, Emory DOP – Summary of internal and external educational opportunities • Bridget Strong, MBA, CCRP, Director - Education and Outreach, Emory OCR – Overview of Emory OCR training • Kesley Tyson, MS, CCRP Start-up and Compliance Coordinator, Emory DOP – Review resources on pedsresearch. org Children’s Healthcare of Atlanta | Emory University 3

PEARLS – what is it? • Pediatric Educ. Ation Research Lunch Series (PEARLS) was created specifically for coordinators and research nurses working in Pediatrics • Sessions will occur 12: 00 noon -1: 00 pm, the 2 nd Friday of every other month (April, June, August, October, December) • This is a joint effort between CHOA and Emory DOP • Coming soon: – alternating locations – video conferencing – CEU credits Children’s Healthcare of Atlanta | Emory University 4

PEARLS – what is it? • Topics were identified from the March 2016 CRC/CRN survey responses that were collected from Department of Pediatrics and CHOA research coordinators and nurses (81 participants!) • Each session will have a panel of “experts” available to discuss topics and answer questions. • The series is meant to be driven by Pediatric CRCs/CRNs! Children’s Healthcare of Atlanta | Emory University 5

Survey Results: How long have you been a Research Coordinator/Nurse? 1 -6 Months ; 9% >5 Years; 40% 6 - 12 Months; 14% 1 -5 Years; 38% Source: 2016 Pediatric CRC/CRN survey Children’s Healthcare of Atlanta | Emory University 6

Survey Results: What areas would you be interested in attending an educational session about? 80% 70% 60% 50% 40% 30% 20% 10% 0% Regulatory Working Through Difficult Situations Billing Protocol Consenting and Understanding Implementation Assenting the Role of the CRC/CRN Subject Recruitment Working with Pediatric Subjects Subject Retention Source: 2016 Pediatric CRC/CRN survey Children’s Healthcare of Atlanta | Emory University 7

Survey Results: What areas would you be interested in attending an educational session about? 80% June Session Topic 70% August Session Topic 60% 50% October Session Topic 40% 30% 20% 10% 0% Regulatory Working Through Difficult Situations Billing Protocol Consenting and Understanding Implementation Assenting the Role of the CRC/CRN Subject Recruitment Working with Pediatric Subjects Subject Retention Source: 2016 Pediatric CRC/CRN survey Children’s Healthcare of Atlanta | Emory University 8

Atlanta Clinical & Translational Science Institute (ACTSI) Resources (see separate slide deck) Children’s Healthcare of Atlanta | Emory University 9

Internal Educational Opportunities Opportunity CHOA Research Staff Meeting Website/Contact Description Dana. faircloth@choa. org Quarterly meeting, at Tullie CHOA Office Park Emory Office for Clinical Research (OCR): Research Matters Research Educational Series occurring 4 – 6 http: //www. ocr. emory. edu/trainin times per year, at Emory University Hospital, g/seminars. html. archived presentations available Emory Department of Medicine: Research Resources 101 Workshop https: //medicine. emory. edu/rese Monthly workshop covering various research/internal-researchtopics, at Emory School of Medicine, resources/events/index. html recordings of prior sessions available CHOA Targeted Research Training Sessions Dana. faircloth@choa. org As needed or requested CHOA IRB Training Jennifer. Mc. Gaughey@choa. org As needed or requested Children’s Healthcare of Atlanta | Emory University 10

Internal Online Resources Opportunity CHOA Institutional Review Board (IRB) Website/Contact Description http: //www. choa. org/Pediatric. Research/For-Professionals/Research. Administration/Institutional-Review. Board/IRB-Training Archived training presentations Emory Institutional Review Board (IRB) http: //www. irb. emory. edu/training/videos. html Library of instructional videos, webinars, presentations Emory Office of Sponsored Programs (OSP) http: //www. osp. emory. edu/trainingtools/i ndex. html Training documents and video library CHOA Research Compliance Emory Clinical Trials Audit and Compliance (CTAC) http: //www. choa. org/Pediatric. Research/For-Professionals/Research. Administration/Research-Compliance Clinical Trial Guidebook Clinical Trial Resources Links to Government regulations and guidance Tools, templates and guidebook Children’s Healthcare of Atlanta | Emory University 11

External Educational Opportunities & Resources National organizations offering education, conferences and certification: Association of Clinical Research Professionals (ACRP) http: //www. acrpnet. org/ The Society of Clinical Research Associates (SOCRA) http: //www. socra. org/ Children’s Healthcare of Atlanta | Emory University 12

Emory Office for Clinical Research (OCR) Training • Training is required at Emory if you work for an Emory investigator. – Introduction to Clinical Research • Online via ELMS • Classroom • To complete any ELMS training at Emory, you must have the following: – Emory University Sponsored ID • • • Amanda Cook assists CHOA employees with sponsored accounts. The sponsored account will provide an Emory email address, including ID and password. A sponsored account doesn’t provide you with access to ELMS. Amanda Cook has to request that access for CHOA employees. Children’s Healthcare of Atlanta | Emory University 13

Emory Office for Clinical Research (OCR) Training programs for clinical research at Emory can be found on OCR’s Training page at http: //ocr. emory. edu/training/index. html > Courses. Note: Training required is based on job roles and job responsibilities. Children’s Healthcare of Atlanta | Emory University 14

Resources on Pedsresearch. org Newly remodeled website offers resources from across the Pediatric Research Alliance (Emory, CHOA, Georgia Tech and Morehouse). Dedicated sections for Clinical Research Resources and CRCs/CRNs www. pedsresearch. org Children’s Healthcare of Atlanta | Emory University 15

Contact Information • • • Terrell Faircloth, Clinical Research Educator, CHOA – Email: dana. faircloth@choa. org – Phone: 404 -785 -3535 Stephanie Meisner, RN, BSN, CCRP, Clinical Research Manager, PRC, CHOA – Email: Stephanie. meisner@choa. org – Phone: 404 -785 -6453 Bridget Strong, MBA, CCRP, Director - Education and Outreach, Emory OCR – Email: bstrong@emory. edu – Phone: 404 -778 -2975 Amanda Cook, Director of Clinical Research Services, Emory DOP – Email: amcook@emory. edu – Phone: 404 -727 -5234 Kesley Tyson, MS, CCRP Start-up and Compliance Coordinator, Emory DOP – Email: kdtyson@emory. edu – Phone: 404 -727 -2189 Children’s Healthcare of Atlanta | Emory University 16