Spring 2016 Research Training Program Agenda SESSION 1, TUESDAY, APRIL 5, 2016
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1 SESSION 1, TUESDAY, APRIL 5, :45 am 8:15 am Sign-In - Refreshments provided, course materials distributed 8:15 am - 8:25 am Introduction Welcome and overview of the six session course. 8:25 am - 8:45 am Pretest A brief pre-test will be given to assist with evaluation of the program and the ability for the training program objectives. 8:45 am - 9:00 am Housekeeping General overview and explanation of notebook/binder. Penelope Jester, BSN, MPH, CCRC, Program Director III, UAB Pediatric Infectious Disease 9:00 am - 9:15 am Good Clinical Practices: An Overview Objective 1 - GCPs and federal regulations - what GCPs are and how they are used in research. Penelope Jester, BSN, MPH, CCRC, Program Director III, UAB Pediatric Infectious Disease 9:15 am 9:30 am BREAK - Refreshments provided. 9:30 am - 10:30 am History and Ethics of Research Objective 2 - Summary of current regulations that impact the implementation of clinical research including the role of IRBs. Sheila Moore, BS, Director of Clinical Studies, VISTAR, Inc., Research Service, Birmingham VA Medical Center 10:30 am - 11:30 am The IRB Process Objective 3 - IRB submission errors, documenting the consent process, enrolling children and obtaining signatures. Nancy Stansfield, RN, MSN, CCRC, CIP, Assistant Director, UAB Institutional Review Board
2 SESSION 2, WEDNESDAY, APRIL 13, :45 am 8:00 am Sign-In Refreshments provided. 8:00 am - 9:00 am Understanding the Protocol Objective 1 - How to use the protocol as a resource; how the protocol can provide guidance to implement a study; and understanding the relationship of the Manual of Procedures to the protocol; and the requirement for adherence to the protocol. Penelope Jester, BSN, MPH, CCRC, Program Director III, UAB Pediatric Infectious Disease 9:00 am 10:00 am The Informed Consent Objective 2 - Overview of the informed consent purpose, development and implementation. Tiffany Grimes, RN, Research Nurse Coordinator, UAB Center for Clinical and Translational Science 10:00 am 10:15 am BREAK - Refreshments provided 10:15 am - 11:15 am Recruitment and Retention Objective 3 - Basic elements needed for successful recruitment and retention of study subjects. Joseph H. Richardson, RN, CCRC, Research Nurse Supervisor, UAB Surgical Oncology 11:15 am-12:00pm Regulatory Document Management Objective 4- Overview of essential documents required to conduct a clinical trial and introduction to the sources requiring regulatory documents. Susan Branscum, CCRP, Regulatory Administrator, UAB Pediatric Infectious Disease
3 SESSION 3, TUESDAY, APRIL 19, :45 am 8:00 am Sign-In Refreshments provided. 8:00am-9:00 am 9:00am-10:00 am UAB Enterprise Code of Conduct Objective 1 - Recognize standards of behavior required of UAB employees, especially as related to the conduct of clinical research, and discuss resources available to support compliance. Katie Crenshaw, JD, MSEd, Associate University Compliance Officer, University Compliance Office Overview of Office of Sponsored Programs (OSP) Processes Objective 3 - Review and negotiation of industry agreements. Bonita Stokes, Sponsored Programs Officer, UAB Office of Sponsored Programs 10:00 am 10:10 am BREAK - Refreshments provided 10:10 am-10:50am Creating Budgets The Basics Objective 4 - The basics of creating a site specific study budget: what you should know. Tina Ayer, BS, CCRP, Program Manager, UAB Nephrology Transplant Clinical Research 10:50 am-11: 20am Integrated Research Administration Portal (IRAP) Overview Objective 5 Using IRAP to help manage clinical trials Molly Moran Lerew, Manager, Research Administration Systems, Office of the Vice President for Research and Economic Development 11:20 am - 11:50 am Conflict of Interest Objective 6 - Basic understanding of the importance and concepts behind conflict of interest. Brenda Cox, MBA, Associate Director, UAB Office Conflict of Interest Review Board
4 SESSION 4, TUESDAY, APRIL 26, :45 am 8:00 am Sign-In Refreshments provided. 8:00 am - 9:00 am Managing a Study Objective 1 - Key elements in preparing for a new study, basic principles of managing a study and discussion on study roles. Bari Cotton, RN, BS, MA, Research Nurse Coordinator, UAB Pediatric Infectious Disease 9:00am - 10:00 am Quality Control / Quality Assurance and Management of CRFs and Source Documents Objective 2 - Overview on understanding and preparing for internal compliance and internal monitoring and understanding of source documents and CRF completion. Karen Savage, BSN, CCRC, Program Director III, UAB Infectious Disease 10:00 am 10:15 am BREAK - Refreshments provided 10:15 am 11: 00 am Understanding HIPAA Objective 3 - Basic understanding of HIPAA. Terri Alexander, Legal Counsel, UAB Office of Counsel 11:00 am 12:00 pm Health Behavior Research Objective 4 - Basic understanding of the study of the determinants and outcomes of actions that affect health. Kathy Harrington, PhD, MPH, Associate Professor, UAB Pulmonology/Behavior Change
5 SESSION 5, TUESDAY, MAY 3, :45 am 8:00 am Sign-In Refreshments provided 8:00 am - 9:00 am The Key to Data Management Objective 1 - An explanation of statistical measures and the importance of recruiting the correct sample of research subjects. David Redden, PhD, Professor, UAB Biostatistics 9:00am 9:30 am 9:30am - 10:30 am UAB Clinical Trials Office (CTO) Clinical Billing Review Objective 2 - Mission and objectives of the CBR, FAP/SiteMinder implementation update. Dawn Bryant Matthews, BS, CCRC, CPC, Clinical Trials Billing Officer, UAB Clinical Billing Review Unit Serious Adverse Event Reporting (Includes Hands-on Exercises) Objective 2 - Familiarization of the importance of SAEs and general principles of reporting SAEs. Leigh Powell, MSN, BSN, RN, CCRC, Research Nurse Coordinator, Cardiovascular Clinical Trial Unit 10:30 am - 10:45 am BREAK - Refreshments provided 10:45 am 11:45 am Device Studies Objective 3 - Differentiate between pharmacological studies and device studies. Cynthia Joiner, PhD, MPH, MSN, RN, Assistant Director, Clinical Research Administration & Finance, CCVC Center Administrator
6 SESSION 6, TUESDAY, MAY 10, :45 am 8:00 am Sign-In Refreshments provided 8:00 am 8:45 am Closing a Study Objective 1 - Reasons for study closure and the key elements of study closure. Jolene Lewis, MSN, RN, Nurse Manager Clinical Research Unit, UAB Hospital 8:45 am 9:30 am Drug Accountability Objective 2 Overview of the drug accountability process. Brenda Denson, PharmD, Investigational Studies Pharmacist / Pharmacy Educator, Children s of Alabama 9:30 am 9:45 am Specimen Management Objective 3 Overview of specimen management. Felicia Hataway, Research Associate, UAB CCTS Clinical Research Unit (CRU) 9:45 am-10:00 am BREAK - Refreshments provided 10:00 am 10:20 am Specimen Handling Objective 4 Brief Overview of Human Specimen Handling and OSHA Donna Williamson, Director, Research Safety Committee, Office of the Assistant Vice President for Occupational Health and Safety 10:20am 11:20 am 11:20am-11:35 am Spring 2016 Monitoring Visits and Audits Objective 5 - Overview on understanding and preparing for a monitor visit and audit. Meredith Fitz-Gerald, MSN, RN, BSN, Nurse Research Manager, UAB Center for Clinical and Translational Science ClinicalTrials.gov Objective 6 Overview of clinical trial registration Penelope Jester, BSN, MPH, CCRC, Program Director III, Pediatric Infectious Disease 11:35 am 11:50 am Post Test A brief post test will be given to assist with evaluation of the program and the ability for the training program objectives. 11:50 am 12:00pm Closing Remarks A summary of the week s presentations and review of resources for future learning and to assist in protocol implementation.
7 SESSION 7, TUESDAY, MAY 17, :45 am 8:00 am Sign-In Refreshments provided 8:00 am 9:00 am Breakout Session Objective 1 Understanding how to work better together as a team. Anthony Hood, PhD Assistant Professor, Management, Informatics Systems, and Quantitative Methods, UAB School of Business 9:00 am-9:15 am BREAK - Refreshments provided 9:15 am 10:15 am Final Remarks Penelope Jester, BSN, MPH, CCRC, Program Director III, Pediatric Infectious Disease
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