Research Institute Newsletter - Spring 2018
Greetings Research Community:
Jamie Caldwell, Executive Director
University of Kansas Medical Center Research Institute
This past winter was a major challenge for our group. There were several staff departures which lead to an increase in timelines to activate new clinical trials and also to maintain the status of our current trials. Despite these challenges we have recruited new staff members. Also, Mr. Kevin Smilor has been named the permanent Director of Clinical Research of Administration and Data Management and provides the following message:
The CRA Regulatory group strives to provide excellent service, informed guidance, and expertise in the clinical trial start-up process and in the ongoing management of a clinical trial. One of our goals is to start studies up as fast as possible while ensuring all applicable regulatory and administrative requirements are satisfied. We are undergoing changes to improve how we manage clinical trials to better serve the research community and strengthen our ability to shorten clinical trial start-up times.
The CRA Regulatory group is re-structuring to change the focus of the Project Manager and add a new role to the group, the Project Assistant. Project Managers will be focused on new clinical trial start up processes. They will continue being a contact and resource for study teams throughout the trial process. This will provide them more time to work on the many requirements to get a study activated. The new role, Clinical Trial Project Assistant, will focus on the many administrative and regulatory requirements after a study is activated to start enrolling.
We are aiming to move into the new structure by the start of June. As we get closer to the implementation date, we will communicate more details about the change and what to expect.
Our group has added new team members. Chris Bessmer and Anita Williams have joined as Clinical Trial Project Managers. They have been in training for about 6 weeks now. Tyler Zimmer and Zelimir Bauk have joined as Clinical Trial Project Assistants. They are just starting their training. You will start seeing communication from these new team members as they start working on trials.
Clinicaltrials.gov requires regular review of study information to verify it is accurate and up-to-date. The “responsible party” (PI, grant awardee or sponsor) is accountable for information posted about the study. To ensure trial information meets site requirements, the information must be reviewed/released at specific times during a study, including:
- Every six months for studies that are enrolling
- Annually for active but NOT enrolling studies
- When there is a change in the enrollment status
- When enrollment numbers need to be updated
- When there are changes in the protocol (e.g. eligibility criteria)
Some studies require results and adverse events to be posted. If your study is an “applicable” clinical trial, results need to be posted within 12 months of the study's completion date (NOTE: this is independent from publishing status).
Clinicaltrials.gov recently emailed notifications to investigators/responsible parties that had one or more records on the site requiring attention. If you received this email, the notification relates to your study records that are non-compliant with site requirements. Common issues include: failure to keep records up-to-date; not releasing previous updates; and failure to review the record at required time points. Failure to update postings when required raises red flags with the FDA.
If you received one of these emails, then you need to take action. Log in at register.clinicaltrials.gov (organization: UKansasMCRI) to review, edit and release study information. If you do not know your login information, are unsure of what study needs attention, how to edit study information, need guidance navigating the clinicaltrials.gov system or have general questions about the site and site requirements, contact Kevin Smilor (firstname.lastname@example.org, 913-588-3230).
The Velos eResearch Clinical Trials Management System (CTMS), commonly referred to as CRIS at KUMC, is used to manage and track clinical trials and study participants at KUMC. Additionally, CRIS is an integral part of the KU Health System billing process. Study and participant data is exported to O2 daily. When information is accurately entered into CRIS, it greatly improves clinical research billing compliance. For compete details or questions, please contact Kevin Smilor (email@example.com, 913-588-3230).
Clinical Research Professional Networking
The Heartland Association of Research Professionals (HARP) is an individual membership organization for all medical research professionals in the Greater Kansas City area. HARP provides members with opportunities to network, to stay informed about trends in health research and to further professional knowledge and skills.
HARP membership is available to all medical research professionals who work with cooperative research groups, academic, government, and private institutions, CROs, SMOs, pharmaceutical and biotechnology companies, device manufacturers, independent research and development organizations, and those who are involved in the management of clinical trials. HARP members benefit from regular networking opportunities, Continuing Education Credits, current research job opportunities and research news for our local Greater Kansas City community.
You can also follow HARP KC on Facebook, LinkedIn, and Twitter for research news updates and current job opportunities!
Kudos to our own Jessica Cosby, Clinical Trials Project Manager I (CRA) who serves as Treasurer.
Since September, 2017, we have implemented two new clinical research training and education programs and offered a variety of presentations in our Research & Discovery Grand Rounds conference series.
Research & Discovery Grand Rounds conference series:
The Research & Discovery Grand Round sessions provide learning opportunities for research personnel across disciplines that foster responsible conduct of research, good clinical practice or science discovery. There have been ten lectures to date.
Research Personnel Monthly Meetings:
In order to provide a program to connect research personnel across disciplines, roles, and expertise, we created the Research Personnel Monthly Meetings which launched in October 2017. It is an informal group meeting for people in the University of Kansas Medical Center and Health System involved in research. The meeting serves as a way to meet the other researchers within the KUMC/KUHS to network, share experiences, mentoring, share ideas, study logistics, and provide support in career development affiliated with any type of research or clinical research. Participants bring topics or ideas that they want additional information on or additional guidance. Each month a different topic is chosen.
Clinical Research Coordinator Bootcamp:
The Clinical Research Coordinator Bootcamp is a professional development opportunity for new and veteran study coordinators and other research personnel that would benefit from the training. The program is a two day training covering the process of how to run a clinical trial from start-up through close-out as well as a variety of resources for research and compliance topics.
Clinical Trials Education Lecture Series (CTELS):
The Clinical Trials Educations Lecture Series are held monthly. These lectures provide a means to share information across the University campus and Health System.
Two Pre Award Administrators will join SPA on April 9th: Todd Carter (Red Team) and Jenna Ridge (Blue Team)
Staff assignments for Post Award changed in December 2017; please review the website to identify the Post Award Administrator associated with your department: http://www.kumc.edu/kumcri/sponsored-programs-administration/spa-staff/staff-assignments.html
The following University of Kansas Medical Center projects have received external funding. This list includes funding awards for new projects that have been received in Quarter 3 of FY18 (1/1/2018-3/31/2018).
- $638,274.00 to Michelle L Redmond from National Institutes of Health for the proposal "Web-based Problem-Solving Self-Management Program for African Americans with Type 2 Diabetes"
- $3,199,995.00 to Joseph Edward Donnelly Jr from National Institutes of Health for the proposal "Teacher versus remotely delivered classroom physical activity breaks"
- $78,964.00 to Amy Elizabeth Noser from National Institutes of Health for the proposal "Assessment of Physical Activity & Sedentary Behavior on Glucose in Teens with T1 Diabetes"
- $1,006,474.00 to Shrikant Anant from Department of Defense for the proposal "Prevention of Triple Negative Breast Cancer by Natural Compounds"
- $1,749,940.00 to Tomoo Iwakuma from National Institutes of Health for the proposal "Control of mutant p53 stability via the mevalonate pathway-DNAJA1 axis"
- $341,250.00 to Jianming Qiu from National Institutes of Health for the proposal "Molecular Bases of Human Parvovirus B19 Entry"
- $2,580,760.00 to Subhrajit Saha from National Institutes of Health for the proposal "Progenitor Cell Based Therapy to Mitigate Radiation Induced Gastro Intestinal Syndrome"
- $43,672.00 to Sharon G Lynch from National Multiple Sclerosis Society for the proposal "MS Disability Scales in the Aging Population"
- $100,000.00 to Christy R Hagan from The V Foundation for Cancer Research for the proposal "Progesterone Receptor Promotes Inflammation in Breast Cancer"
- $19,998.00 to Neil Alan Segal from Foundation for Physical Medicine and Rehabilitation for the proposal "Advancing Physiatric Care of Tendinopathy through Controlled Study of Healing Following Percutaneous Ultrasound Tenotomy"
- $424,000.00 to Lisa Sanderson Cox from Hackensack Meridian Health [National Institutes of Health] for the proposal "e-Decidete: Mobile Cessation Support for Latino Smokers"
- $200,000.00 to Danny Ray Welch from National Foundation for Cancer Research for the proposal "NFCR Fellow - Welch"
- $31,998.00 to Judy Ann Johnston from United Methodist Health Ministry Fund for the proposal "Healthy Congregations Covenant Program"
- $50,000.00 to John P Thyfault from Arkansas Children's Hospital Research Inc. [U.S. Department of Agriculture] for the proposal "Impact of Fitness and Exercise on Bile Acid Metabolism"
- $13,654.00 to Judy Ann Johnston from Kansas Dept. of Health and Environment for the proposal "Contract for Research and to Provide Technical Assistance to Early Detection Works Staff"
- $45,080.00 to Cheryl Elaine Skinner from American Association for Respiratory Care for the proposal "Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes"
- $224,732.00 to Sue Min Lai from Kansas Dept. of Health and Environment for the proposal "Kansas Cancer Registry- Breast and Cervical Cancer Screening Component"
- Site Contract to Lemuel R Waitman from Duke University / Duke Clinical Research [Novartis Pharmaceuticals Corp] for the proposal "PROVIDE-HF: Patient Reported Outcomes investigation following initiation of Drug Therapy with Entresto (Sacubitril/Valsartan) in Heart Failure"
- $27,597.00 to Judy Ann Johnston from Kansas Dept. of Health and Environment for the proposal "Coordination and Support of KSCQI Community-Clinical Linkages Activities"
- $30,000.00 to Cheryl A Gibson from KC Healthy Kids for the proposal "Healthy Kids Bright Futures Program Evaluation"
- $37,710.00 to Siddharthan Sivamurthy from Kansas Dept. of Health and Environment [Department of Health and Human Services] for the proposal "Shared Plan of Care for Children and Youth with Special Health Care Needs"
- $2,000.00 to Ann Marjorie Davis from Kansas State University [National Institutes of Health] for the proposal "Cognitive and Neurobiological Approaches to Plasticity (C-NAP)"
- $523,526.00 to Roy A Jensen from Department of Defense for the proposal "Prevention of Triple Negative Breast Cancer by Natural Compounds"
- $125,000.00 to Douglas E Wright from Kansas Board of Regents for the proposal "Kansas Board of Regents matching funds for K-INBRE"
- $126,262.00 to Jennifer Rose Klemp from Kansas Dept. of Health and Environment [Centers for Disease Control and Prevent] for the proposal "Coordination and Support of Kansas Survivor Care Quality Initiative (KSCQI)"
- $50,000.00 to Cheryl A Gibson from After the Harvest for the proposal "After the Harvest Program Evaluation"
- "$153,000.00 to Darren P Wallace from NovaTarg [National Institutes of Health] for the proposal ""Novel and Kidney Selective AMPK Activators to Treat Polycystic Kidney Disease"
Spring has been a busy time for internal opportunities. As you may know we work with the Faculty Assembly Research Committee, KUMC Research Institute Research Committee, and individuals with the Frontiers Pilot & Collaborative Studies Program, just to name a few, to be able to provide these great programs.
Here is an update on these opportunities:
1. This season started off with, 16 awards for the Winter Faculty Travel. Please note the next round for faculty travel funding is due by May 1st.
2. The April 1st deadline for the Spring Enhancement, we received 10 applications, three of which were funded.
3. The Clinical and Translational Pilot Research Grant and the Lied Basic Science Grant Programs combined have received over 100 applications that are currently being for reviewed. Funding award notices should go out near the end of May.
4. On April 2nd, two individual nominations for the Chancellors Club Research Award were received and are in the process of being reviewed.
Finally, important dates to remember:
1. Faculty Research Investigator Awards and Research Administrator Awards will be due early August
2. Save the date, Faculty Research Day and Poster Session, will be held on October 12, 2018, HEB, Ad Astra Room, more information will be available soon.