Clinical Trials Tutorial

NCURA is proud to offer our online tutorial on clinical trials management. Learn at your our pace! Choose the start date that works best for you to begin your access. You will have 10 weeks to complete the lessons and 30 question multiple-choice final exam at your own pace - ALL lessons and the final exam are available from the start.

We have developed a thorough overview of this complex process. As a primer it is intended for those new to clinical trials, or who have had very limited exposure. The course will focus on key administrative, financial, and regulatory issues that arise in planning, funding, conducting, and closing-out clinical trials. You will not become an expert in every aspect of clinical trials but you will become knowledgeable about many facets of the clinical trial process. Participants will learn about:

  • Clinical trials as a subset of human subject research
  • The unique regulatory environment for clinical trials
  • The basic elements of a clinical trial
  • Developing and managing a clinical trial budget and expenditures
  • Key negotiation issues that often arise in a clinical trial agreement
  • The roles and responsibilities played by institution and sponsor staff’s in the creation and management of clinical trials.
  • Close-out of clinical trials

The tutorial will offer interactive learning activities as well as knowledge reviews for each lesson. The course will end with a 30 question multiple-choice final exam, and offers a downloadable certificate of completion for those who successfully pass the final exam (80% or higher). If you do not successfully pass the final you have the option to retake the exam during your enrollment period. Registrants should expect to spend approximately 1-2 hours per lesson on the course material.

The course will include a case study with each lesson. This will help the registrant put the material into context. Lessons include:

 

Lesson 1: Introduction to Human Subjects Research

Lesson 2: Getting a Clinical Trial Started

Lesson 3: Financial Issues

Lesson 4: Contracts and Agreements

Lesson 5: Operations

Lesson 6: Close out and Audit

Final Exam 

Developed By

Michael Amey

Associate Dean,
Office of Research Administration,
Johns Hopkins University School of Medicine

Mike Amey has worked on and managed federal sponsored programs for more than 38 years, the last 32 of which have been at Johns Hopkins University School of Medicine where clinical trials, research compliance and the systems that support clinical research have been a major part of his career. As Associate Dean for Research Administration he and his staff have been responsible for negotiating clinical trial agreements for Johns Hopkins since 1980. At Johns Hopkins School of Medicine annual sponsored support from pharmaceutical and biotechnology companies is about 11% of all sponsored programs and has exceeded $70M per year.

Mike has consulted on research administration and compliance activities and has presented and taught extensively at Hopkins, NCURA, SRA, AAMC and other groups. He was an invited participant in the Association of American Medical Collages (AAMC) paper, “Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials,” 2005. He serves as founding advisor to the Johns Hopkins University School of Nursing, Research Coordinator Training Program and as a leader in the Committee on Information Systems Supporting Clinical Investigation. Mike has been an important manager in the rebuilding of the Johns Hopkins Medicine IRBs, development of web-based electronic IRB and Conflict of Interest systems and current development and deployment of a Clinical Research Management System. He is an active member of both the University’s Research Compliance and. Institutional Compliance Committees. He serves a Board Member of the Council of Governmental Relations (COGR) where he served on the Working Group on Human Research Protections and currently on the costing policies committee.

Penny Cook

Executive Director,
Grants & Contract Administration,
School of Medicine, Yale University

Penny Cook is currently the Executive Director of Grant and Contract Administration for Yale University School of Medicine. She and her staff are responsible for the negotiation of clinical trials for the University. Both at Yale and at previous institutions, including the Aaron Diamond AIDS Research Foundation, the Rockefeller University and New York University (NYU) Medical Center, she has been involved in promoting clinical and translational research through defining, promoting, and maintaining business standards and practice, evaluating clinical billing practices, and implementing HIPAA regulations. She has been involved in the creation of two clinical trials offices and works closely with the newly established Center for Clinical Investigation at Yale. She has spoken frequently at NCURA meetings on the subject of clinical trials and clinical trial negotiation. In addition to an undergraduate education in biology and nursing she holds a master's degree in health administration from NYU.

Edward Herran

Director,
Office Of Sponsored Projects,
Memorial Sloan-Kettering Cancer Center

Ed serves as the Director of the Office of Sponsored Projects at Memorial Sloan-Kettering Cancer Center in New York City. Before he arrived at Sloan-Kettering four years ago, he was Director of Research Administration, Department of Medicine, Indiana University Medical Center for 16 years. Ed was at Purdue University for 10 years before joining Indiana University Medical Center. Ed has had extensive pre and post award experience. Ed is the immediate past treasurer of the National Council of University Research Administrators, a past Board member, has been on many committees, and has held many offices at the regional level.

Ed has presented at the regional level on contract negotiation and how to appropriately budget for a clinical trial at many NCURA regional and annual meetings. Also, he has presented numerous times at the Annual Meeting and other NCURA conferences on such topics as Managing Stem Cell Research; Bridge Research – Translational Research; Data Sharing and PubMed; Administrative Impact of Multiple PI’s; and Growth of International Research. He also was a faculty member on three NCURA live video workshops on topics ranging from pre and post award essentials, departmental research administration to current post award issues.

Gunta Liders

Associate Vice President for Research Administration,
University of Rochester

Gunta Liders is the Associate Vice President for Research Administration at the University of Rochester. In this role, she serves as a senior administrative officer of the University responsible for non-financial aspects of sponsored programs administration, including the development and implementation of research policies and processes. Gunta and her staff are responsible for the negotiations of clinical trial agreements; the expenditures on industry-supported clinical trials exceeded $25 million in FY ’07. Gunta serves on numerous University of Rochester standing committees such as the conflict of interest committee, technology transfer policy committee, institutional biosafety committee, and radiation safety committee. One of her key responsibilities is the development of conflict of interest plans and strategies for clinical researchers.

Gunta is the University of Rochester’s primary representative to the Council of Governmental Relations, and serves on its Board of Directors and Chair of its Research Administration and Compliance Committee. Gunta also currently serves on the Executive Committee of the Federal Demonstration Partnership, and on the Board of Directors of the National Council of University Research Administrators (NCURA). She has received two Distinguished Service Awards from both the national and regional chapters of NCURA. Gunta is contributing editor for the monthly “Managing Federal Grants” newsletter. Gunta is a chapter author for “Managing Federal Grants: A Guide to Colleges and Universities”, as well as for “Sponsored Research Administration: A Guide to Effective Strategies and Recommended Practices”. Gunta has moderated and presented at numerous NCURA sessions on the administration of clinical trials. She has also served as an external reviewer and financial consultant for the National Institutes of Health.

Garrett Sanders

Vice President
Research and Sponsored Programs Operations
The Research Foundation of SUNY

Garry is a research administration professional with twenty-nine years experience helping research organizations manage the business of sponsored programs. He has negotiated clinical trial agreements with the major pharmaceutical and biotechnology companies. He previously served as Director of Sponsored Research at the Ordway Research Institute, a not-for profit clinical research and biotech institute in Albany, New York.. Prior to starting up Ordway, he was Assistant Vice President for Research and Director, Office for Sponsored Programs at the University at Albany, SUNY. Garry served as Assistant Director, Office for Research and Project Administration at the University of Rochester, and worked previously at the National Institutes of Health (NIH) serving as a Grants Manager for the National Heart Lung and Blood Institute and the National Eye Institute. He is a former Presidential Management Fellow with the federal DHHS.

He is a consultant to research organizations, hospitals, universities, and corporations in the business of clinical research administration. Garry also served as an administrative reviewer for the NIH General Clinical Research Center program and for NIAID AIDS program.

He received the Distinguished Service Award from the National Council of University Research Administrators in 2005. In 2003, he initiated the Council’s Leadership Development Institute and serves as a mentor for program participants. He served on NCURA’s Board of Directors from 2001-2003 and chaired the association’s Professional Development Committee from 2003-2005. He was editor of NCURA’s Clinical Trial Handbook.