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CTC Newsletter - September 2007 Issue
- Commitment to Clinical Trials Compliance
- Clinical Trials Improvement Campaign 2007
- Education and Training Program
- CTC Question and Answer Corner
- Ask The Auditor
Commitment to Clinical Trials Compliance
By Dr. Bruce Kone, Dean, College of Medicine
First, I wish to congratulate Dr. Craig Tisher and Peter Pevonka on their vision and Yvonne Brinson on her leadership in creating the Clinical Trials Compliance Office and services. Secondly, I ask every member of our clinical research community to join me in continuing to keep Clinical Trials Compliance (CTC) a high priority.
The UF Health Science Center and College of Medicine rank among the top clinical trials research environments in both volume and revenue. With this distinction comes responsibility for performing safe, effective and sustainable new drug and device development for the nation and the world.
Successful and efficient clinical trials compliance functions, systems and support are costly and complex. However, done well, the cost of compliance in the long-run can be reduced. We must all work together to ‘get it right’ by continuing to commit to the delivery of quality care to our study participants while engaging in ethical and sound research and business practices.
The Clinical Trials Compliance Office has made tremendous progress in building partnerships among our Investigators, Clinical Research Teams, Research Administration & Compliance, Faculty Group Practice and Shands. These partnerships have resulted in collaborative approaches to the development of CTC policies, processes, tools, and most importantly, training. I thank all Faculty and Research Staff for their efforts to adopt the new CTC processes. Soon, CTC will join our mandatory compliance training activities as we move forward in this vital work.
Upholding our reputation for excellence requires we continue our dedication to quality care, support and protection for our researchers, and fiscal integrity in all clinical trials activities.
Please contact Yvonne Brinson, Director, CTC Office or call 352-273-5946 early in your clinical trial planning for help in navigating the CTC process. Also visit the CTC website for further information, resources, or to register for training.
Thanks again to everyone for their support and commitment to clinical trials compliance.
Visit the Association of Academic Health Centers (AAHC) website for News Release from President/CEO Dr. Wartman: ‘Investing in Clinical Trial Compliance Top Academic Health Center Priority. AAHC Says Costs Emerging National Issue.’ May 15, 2007
Clinical Trials Improvement Campaign 2007
Certificate of Appreciation to all of the Ad Hoc Committee Members!Our Ad Hoc Committee has been meeting monthly for a full year! We are 54 members strong including faculty, administrators and staff from the University of Florida Health Science Center Colleges, Shands Hospital and Faculty Group Practice. We are committed to building a centralized system of procedures that are efficient, effective and supportive of our policy and standards; track, report, self-evaluate and continually improve upon; and develop a closeout process that concludes our clinical research in a clear and well-documented manner that demonstrates compliance with all applicable laws and regulations that pertain to clinical research.
On behalf of the Clinical Trials Compliance Office, we would like to send out a sincere thank you to all of our Ad Hoc Members who continue to work collaboratively and participate in this exciting and complex campaign. You are making a difference! Our program would not be where it is today without your participation, useful materials and, most of all, great ideas. We have come a long way is a short time. Keep up the great work!
Education and Training Program
Our education & training program started 2007 with a bang!  The CTC Office launched the education & training program in January 2007 by offering 5 role-based courses. A 6th course, Why Track Services Now? Save Time & Money Later, was added to the curriculum in June. After only 7 months, we are very proud to have had nearly 600 faculty and staff attendees attend our classroom lectures or one of our 15 on-site group sessions. Feedback has been very positive and participant input has helped improve and shape our program. |
Key To Successful Submissions….
Involving the CTC office before you begin preparing any paperwork can save time and energy. In addition to the classroom sessions, I work individually with faculty and staff to provide direction on the CTC process, submission requirements and form completion.
Thank You!
Since each research study is unique and there is no “cookie-cutter” recipe, it is difficult to craft the “perfect” form or set of instructions. We cannot succeed alone and, as such, I would like to personally thank the following individuals for their outstanding contributions to improving our forms and resources:
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Aundrea Corbit |
CTC Question and Answer Corner
Each issue of the newsletter includes new questions and answers that are added to the FAQ section of Getting Help on our website. Click here to view the latest FAQs.
Ask The Auditor
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Welcome! 
Welcome to Ask The Auditor. In this area of the newsletter we will keep you informed about the auditing process by answering your questions. Also, we will be launching the “Conducting Compliance Reviews” on the Clinical Trials Compliance website soon, so stay tuned. Do you have an audit question? Send it to Felicia at ffitzger@ufl.edu. |
| Felicia Fitzgerald Auditor | |
Click here to view Q&A from the Auditor.
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