"Resurrection Medical Center joined the CTSU in July 2005 as a CTSU Independent Clinical Research Site (CICRS). The CTSU lives up to its mission of providing support for participation in NCI-Sponsored Phase III cancer treatment trials. The CTSU's innovative model is no accident. They didn't just copy their model from existing cooperative groups. The CTSU listened to investigators and research staff and reinvented the concept of clinical trials support. It takes a group of committed professionals to provide consistent, excellent service. The support we received during the application process through enrolling our first patients on CTSU studies has been tremendous!
We have been very impressed with the accountability and process improvement systems used for telephone and e-mail contacts. The CTSU utilizes best practices from the call center support industry in its customer service approach. The CTSU provides us with clear, timely communications and adjusts their approach based on our feedback.
The website is easy to navigate and logically intuitive. Processes are streamlined and sensible.
We are proud to be a part of the CTSU. It is a pleasure to work with this group."
PHOTO from left to right : Sharon Glinski, CRA, MaryAnn Kosic, RN, Christopher Rose, MD, and Joan Kram, RN, CHE
See the CTSU CICRS page for more information regarding CTSU Independent Clinical Research Sites (CICRS).
The Moses Cone Health System Regional Cancer Center in Greensboro, North Carolina is involved with CTSU through its membership in the Southeast Cancer Control Consortium CCOP. The Clinical Research Department at the Regional Cancer Center has been actively involved in clinical trials since the mid 1980's. The current staff of the department is committed to excellence in clinical research.
Over the last several years, the quantity of safety reports for all cooperative group trials has increased dramatically. Jacquie Prevette, the person who submits the safety reports to our IRB, is keenly aware of how time-consuming this activity is. The new Drug Safety Notification/SAE Browser under the Protocol section of the CTSU Member portion of the web site is a great tool. The organization of the information for each safety report contains most of the same information that is submitted to our IRB. Now that Jacqui is able to print the pages with the safety report information she will be saved hours of work. When new safety reports are added in a timely manner, it easily allows us to submit the reports within the required 90-day time frame.
We look forward to CTSU continuing to work on systems that will help sites with the regulatory workload.
PHOTO: Clinical Research Staff of the Moses Cone Health System Regional Cancer Center:
In front, Jacqueline Prevette (Administrative Secretary); 2nd row, Teresa Thompson, RN, MSN, CCRP (Clinical Research Nurse) and Vivian Sheidler, RN MS (Clinical Research Manager); 3rd row: Mary Wegenka, RN, MS, AOCN (Clinical Research Nurse), Anna Hurd (Data Assistant), Nikki Eldreth, RN, BSN (Clinical Research Nurse), and Cindy Shaw, RN BSN, CCRP (Clinical Research Nurse); Back row, John E. Feldmann, MD (Principal Investigator).
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When we broke ground on the new cancer center at our site, we immediately started to dig for the best answer to meet the necessary challenge of opening and managing oncology studies for a new oncology group. As the foundations were poured for the new facility, we received a flyer on CTSU and we began to lay our own building blocks for the future. CTSU personnel have been on the job 24/7 and every question gets immediate attention. As a brand new start-up oncology site, working with CTSU provided access to a variety of trials and the ability to build our group "brick by brick" along with the walls going up for the new facility. Through the Regulatory Support System, CTSU provided a blueprint and "apprentice" mentoring plan for our early efforts guiding us through every phase of construction. The CTSU website offers the best tools to get the job done with quick access to all study and regulatory documentation just a "click" away, and a HELP staff keeping us "safe" on the job with immediate attention to calls from the job site. As an academically-affiliated center with a local IRB, we are now looking at future construction for a whole new "floor" to the trials component for our center by "subcontracting" with local regulatory authorities to work with the CIRB. So, with CTSU and CIRB architects and engineering to assist us, we are able to offer clinical trial opportunities to our patients even before the doors of the new center open on a new era in cancer care for our area.
Watch us grow!
Opening September 2005: The Edwards Comprehensive Cancer Center.
(Photo: (seated) Maria Tirona, MD, and Francis Cuevas, MD (Principal Investigators); (standing, left to right) Mary Beth Cordle, Administrator, Clinical Drug Trials, Leann Ross, RN, OCN (Study Nurse), Donna Duncan, RN, (Oncology Nurse), University Physicians Internal Medicine, a division of University Physicians & Surgeons, Inc. located in Huntington, WV, affiliated with Marshall University, Joan C. Edwards School of Medicine. )
If Clinical Trials are a journey, then the CTSU partnered with CIRB is like navigating trials with a GPS rather than a folded up road map. The CTSU staff are always waiting to lend a hand and encourage every step along the way. The RSS (Regulatory Support System) page is like having a travel agent working 24/7 to let you know when your trials IRB approval expires. CTSU makes clinical trials in the community setting a possibility for so many patients. It is such a blessing to be a part of CTSU and CIRB. We are proud to be community members. We really appreciate all the support we receive from both CTSU and CIRB and look forward to a long standing relationship.
(Photo: Jack MacNeill, MD, Principal Investigator and Sherry Swint, RN, MSN, Study Coordinator for Centra Health and Lynchburg Hematology-Oncology Clinic in Lynchburg, VA)
The University of California, San Diego has participated in the CTSU since November 2001 as a long time member of CALGB. I was quite apprehensive about how the CTSU Central Regulatory Office would be able to provide the same quality service as our cooperative group. I am now a huge proponent of the CTSU. The CTSU has provided professional, courteous, and timely service each and every time. The development of the RSS database has:
Allowed me to refer potential study participants to other institutions when a trial is not open at our site, by having the ability to view an accurate and up-to-date list of open studies at other institutions by NCI site code.
Allowed me to check the regulatory status of our cooperative trials on a user friendly site.
The occasional event has occurred when our regulatory docs were not up-to-date with the CTSU at the time of patient enrollment, and the CTSU staff have 100% of the time, entered the required data into the database promptly and usually within one hour. A friendly CTSU staff member has always followed up to verify the issue was resolved. I look forward to continued participation in the CTSU.
(Photo: Jessica Silva-Gietzen, CCRC, Moores UCSD Comprehensive Cancer Center )
The Praxair Cancer Center at Danbury Hospital is dedicated to providing comprehensive cancer care. Committed to quality, the center offers expert diagnosis and treatment by multidisciplinary teams, including a long tradition of participation in cooperative group and pharmaceutical clinical trials.
As the oncology research coordinator, I collaborate with the oncology team to identify protocols for our patients. The collection of clinical trials available from the CTSU has allowed us to enhance our research program to better meet the needs of our community cancer center's patient population.
I have found the CTSU group and the web site to be an excellent resource in several ways:
The comprehensive presentation of both the clinical and regulatory information improves the processes for initial preparation for IRB review and continued protocol maintenance
Updates and changes to clinical trials are communicated in a timely manner
The help desk responds rapidly and considerately to my questions
The data submission tools help with organization of information
We look forward to a maintaining our relationship with the CTSU and their high level of commitment to quality cancer care.
(Photo left to right: Pat Hough RN, BSN, Manager of the Praxair Cancer Center, Robert Kloss MD, CTSU Principal Investigator, Sue Gran RN, MPH, Oncology Research Coordinator.)
Providing excellent cancer care through innovation, education, and quality assurance has been a hallmark of Community Medical Centers Cancer Program located at the California Cancer Center. Because research is a high priority, the California Cancer Center participates in clinical trials through the cooperative groups as well as pharmaceutical companies. We first learned of the CTSU when I attended an RTOG Meeting in Montreal in June 2002 and we were able to enroll our first patient that October. Through the CTSU we are able to find protocols that fit our patient population. The CTSU website is user friendly and all the staff have been very courteous and helpful. Having the ability to click on a protocol and pull up any form that I need is important to me. Additionally, I find that using the CTSU Transmittal Sheet helps keep me organized and is a quick reference tool when checking to see if something was already submitted.
(Photo:Bonnie Harkins, RN, OCN, CCRP)
"I think that many investigators, clinical research professionals, and
research nurses were apprehensive about how the CTSU would add value to
their research programs. At our program, we maintain a regular watch on the
CTSU menu of protocols. When a gap has developed in the protocols that are
available through our major cooperative group, CALGB, we have opened CTSU
studies, particularly when the gap involves a quantitatively large segment
of our referrals. The CTSU has enabled us to offer those patients high
quality, NCI-sponsored studies and maintain our high accrual standards,
during what previously was "down time" for our research office."
Alan P. Lyss, M.D.
Director, Cancer Center and Clinical Research
Missouri Baptist Medical Center
The ultimate goal at the University of Alabama at Birmingham Comprehensive Cancer Center, is to offer every patient participation in a clinical trial. The CTSU has enabled us to add to the menu of studies we activate at our site. The IRB application process is simplified and turnaround time is minimized. The process of registering new studies with CTSU and registering patients on studies has been fine tuned and staff at the CTSU helpdesk and registration desk assist with any potential problems to ensure accurate and efficient completion. Our accrual benefited from activating studies through CTSU, and most importantly, our patients have the opportunity to participate in clinical trials that offer them state-of-the-art treatment while exploring state-of-the art academic questions.
Carla I. Falkson, M.D.: Principal Investigator, University of Alabama at Birmingham Comprehensive Cancer Center.
Rene Jooste M Pharm, CCRP: Program Director,University of Alabama at Birmingham Comprehensive Cancer Center.
The Kaiser Permanente Oncology Clinical Trials program of Northern California was established to provide our 3 million + patients access to well designed oncology trials. The CTSU gives our oncologists and patients just that. The CTSU's expanding menu of excellent trial options is a great addition to our established NSABP, SWOG, and Pharmaceutical access. We were able to enter over 43 patients in the last 6 months of 2003 to the trials available to us exclusively by CTSU. As original EPP pilot and now CTSU members, we have observed the CTSU's clear commitment to continuous improvement and trial program expansion. The CTSU enrollment staff has been very helpful and cooperative. We look forward to new trials and opportunities.
(Photo from left to right:
Andrea Rodoni, Operations Specialist , Louis Fehrenbacher MD, Medical Director, Desiree Goldstein RN, Program Manager)
Our centre first became involved with the CTSU through the submission of regulatory documents for one of our co-operative groups. Since that time, several of our oncologists have become aware of the multitude of trials available to our centre through the CTSU process. We are currently pursuing several new trials endorsed by NCIC CTG and plan to open our first trial with the CTSU within the next few months. Our experience thus far has been very positive. Our questions are always addressed promptly. In addition, the CTSU Canadian Home Page and Information for Canadian Investigators has been a welcome addition to your site. We are now able to track the status of the Clinical Trial Application (CTA) with Health Canada and access country specific regulatory documents easily. Thank you for making your site accessible to Canadian participation.
(Photo from left to right:
Janice DeWit, Ethics & Regulatory Affairs Coordinator, Clinical Investigations Office, CancerCare Manitoba
Kathryn Dyck, Ethics & Regulatory Affairs Coordinator, Clinical Investigations Office, CancerCare Manitoba)
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