Volume II, Issue 4 April, 2002	Research and Sponsored Programs

Human Subjects Research Auditor Joins R&SP
In Dave's new role as the Human Subjects Research Auditor, he will have the challenging task of assisting in the development of this new position. The Human Subjects Research Auditor reports to the Director or Research Compliance Administration, Shelley Bizila. The responsibility of the Human Subjects Research Auditor is based on the Standard Operating Procedures (SOPs) for IUPUI/Clarian that will soon be released. The auditor will carry out independent audits of research studies, investigators, operations or departments within IUPUI/Clarian for human subjects research. The research auditor will sample research study information and overview research processes to gain an appreciation as to the overall quality and compliance for a given study or department. Identifying areas of research noncompliance or potential noncompliance, advising, and consulting with researchers and departments will correct problems such that the research operations involving human subjects at IUPUI/Clarian are of high quality and meet University and regulatory agency standards. To view the complete R&SP organization chart see: http://www.iupui.edu/~resgrad/org-chart/spon-org.htm.

New Systems Administrator to Oversee ERA System
The position of ERA System Administrator was developed to bridge the technology gap and meet the requirements of the development team and individuals utilizing the ERA tools. Avery will serve as coordinator and consultant between the content experts and the development/programming team, establishing and implementing new releases as the system evolves and includes more modules. Avery will serve as the main liaison between user groups (schools, academic departments, research offices, service/administrative offices) and Research and Sponsored Programs, Sponsored Research Services, the regional campuses, enterprise system administrators and the ERA development team.

Relocating from the Silicon Valley (San Jose, CA) Avery brings with him a host of entrepreneurial energy and conceptualization for accomplishing the ERA System Administrator tasks at hand. Avery is a graduate of San Jose State University, San Jose, CA, with a Bachelor's of Science Degree in Industrial Technologies. He brings ten plus years of employment history hosted by companies that have called on his expertise in System Administration, Data Management and Design, Training, Communications, and Technical Consulting.

Making IUPUI his new home, Avery is excited about this opportunity and is looking to enhance his education within the newly established school of Informatics focusing on Human Computer Interaction. To view the complete R&SP organization chart see: http://www.iupui.edu/~resgrad/org-chart/vc-org.htm.

CTP Introduces New Clinical Research Consultant
One of the functions of CTP is to promote and facilitate the responsible conduct of clinical research at IUPUI. A part of that process includes the education and training of staff. Gail's responsibilities will include being available to investigators and coordinators, upon their request, to provide consultation, guidance, and to answer questions about the various aspects of clinical trial management (regulatory affairs, consents, source documents, data documentation, budgets, adverse events, IRB, etc). In addition, she will assist CTP staff to develop future educational programs for those involved in clinical research activities in the School of Medicine (including the Wishard and VA systems.)

Over the five years since its inception, the Clinical Trials Program has expanded its role on campus reaching out to industry and promoting IU as THE Midwest place to do research. With Sharon Moe, MD as Medical Director and Pamela DeWeese as Administrative Director, the program has helped shape the IU program as an excellent resource for investigators/coordinators, sponsors and the general public. Now with Gail's expertise, they will continue to support research through a more direct mentoring process for staff. "Old" and new faculty/research coordinators may contact Gail through the office at 278-8210 for resources related to the practical and compliant conduct of trials as well as tools to enhance audit preparation and quality improvement. See http://dmedicine.iupui.edu/ctp/index.htm for more information about the Clinical Trials Program.

Research and Sponsored Programs UN 618 General - 274-8285 Research Compliance - 274-8289 Sponsored Program Development - 278-0249

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