3:00 p.m. 2:00 p.m. 3:30 p.m. 4:30 p.m. Break Afternoon February 26, 2004 Concurrent Sessions Standard Operating Procedures for Human Research Compliance Officers Speaker: Karen Jeans, MSN, RN This session addresses the regulatory requirements together with hints and practical tips that are not defined in writing. Topics cover developing standard operating procedures for electronic, paper, and verbal communications, auditing procedures, and archiving. Pharmacists Responsibilities in Clinical Studies Speakers: Mike Sather, PhD, CSP Crystal Harris, PharmD, CSP This session addresses pharmacists’ involvement and responsibilities in clinical studies involving drugs and devices. It will include the responsibilities of investigators and identify where the research pharmacist fits in. Organizational Structures for RCOs Moderator: Marisue Cody, PhD, RN Panel Members: Ellen Graf-Jansen, RCO, Cincinnati Angela Lacy, RCO, Portland Mindi Styn, RCO, Pittsburgh Virginia Wiley, RCO, Nashville A variety of issues regarding organizational relationships for RCOs will be addressed in this session. The panel will provide insight and experiences with different models, what works, what doesn’t and future directions for RCOs in the VA. The Regulatory Aspects of Adverse Medical Events and the Use of MedDRA in Coding Adverse Medical Events Speaker: Kathleen Swanson, RPh, MS, CSP Reporting and monitoring adverse events in clinical trials in order to protect patient safety is the responsibility of many individuals. The focus of this presentation will be to outline the roles of the investigator, IRB and sponsor in adverse medical events and how these roles are facilitated through individuals at the medical center. A summary of key regulations and policies involving adverse events will be presented. A brief discussion of the Medical Dictionary for Regulatory Activities (MedDRA) will be provided. Research Compliance OfficersResearch Pharmacists Administrative Officers Animal Research Update on AAALAC, IACUC/SRS, and Speaker: Michael Fallon, DVM, PhD This session will summarize important trends in AAALAC mandatory citations, provide some ideas for preventing duplication of review efforts between the IACUC and the SRS (Subcommittee on Research Safety; also known as the Institutional Biosafety Committee, or IBC), and cover important new features of VHA Handbook , "Use of Animals in Research." Contracting Speaker: M. Brenda Hebert This session will provide information on the different types of contracts that are used in the research setting. Participants will learn how to prepare a statement of work and the elements that should be incorporated into a well-constructed contract.

10:30 am 9:30 am 11:00 am 12:00 p.m. Break Morning February 27, 2004 Concurrent Sessions FDA Regulations Part 1 Speaker: Carolyn Hommel, FDA This session will address basic regulatory requirements for FDA regulated research. Topics will include: The informed consent process and documentation; protocol non- adherence: deviations and violations; adverse event reporting: sponsors, IRB, FDA; investigational drug accountability: dispensing, storage and documentation; and source documentation: accuracy and reproducibility. FDA Regulations Part 2 Speaker: Carolyn Hommel, FDA This session is a continuation of part 1. Time will be left for questions and answers. Research Compliance OfficersResearch Pharmacists & Administrative Officers Demystifying the Competency Conundrum Speaker: Sylvia McKee, MN, RN, BC Coordinator, Clinical Staff Dev. & Education, VA Salt Lake City Health Care System This session will help solve the mystery of competency assessment by discussing the process of establishing a high-quality competency program in the research setting. A high quality competency program is required to satisfy the JCAHO requirement that every staff member of a healthcare organization is competent to perform his/her job. Biosafety and Security Speaker: Brenda Cuccherini, PhD This session will provide an update on the revision to VHA Directive "Control of Hazardous Materials“. It will include discussion regarding the difference between biosafety and biosecurity, why both are important and how they are complementary. Other issues that will be discussed include: The role of the biosafety officer and responsible official, coordination and interaction with other medical center offices including the VA Police, the facility's/VISN IH staff, and site visits.

2:30 p.m. 1:30 p.m. 3:00 p.m. 4:00 p.m. Break Afternoon February 27, 2004 Concurrent Sessions Overview of ORO and the Common Rule Speakers: David A. Weber, PhD, ORO Joan Porter, DPA, MPH, ORO This session will provide an overview of the restructuring of ORO and their oversight responsibilities including audits, reporting requirements, and handling of research misconduct. This will be followed by a fundamental walkthrough of 38 CFR part 16 with reference to VHA handbook NCQA Accreditation and Research Pharmacies Speakers: Jessica Briefer French, NCQA Karen Jeans, MSN, RN As part of the VA Human Research Accreditation Protection Program, NCQA evaluation of the investigational pharmacy is a critical component. This session will examine VA regulations described in M-2, Part VII and describe the NCQA evaluation of the regulations during the on-site survey visit. Affiliate IRB and NCQA Accreditation Speakers: Jessica Briefer French, NCQA This session will address frequently asked questions by VA research programs that use affiliate IRBs to review their research. Such questions include: What are the VA responsibilities in providing oversight of the affiliate IRB? What are the affiliate responsibilities in the NCQA accreditation survey process? What happens if the affiliate IRB does not receive accreditation from PHRP or AAHRPP? Panel Discussion: Research Pharmacist Issues Moderator: Karen Jeans Panel Members: Jennifer Mixon, RPh, Charleston Debra Mundie, RPh: Richmond Herschel Rayles, RPh, North Chicago VA Kathleen Swanson, RPh, Alburqueque A variety of topics concerning investigational pharmacists will be addressed in this session. Discussion will include experiences with the NCQA pharmacy on-site survey, cost impact evaluations, storage, accountability, and evolving regulations. Research Compliance OfficersResearch PharmacistsAdministrative Officers &