How can I learn about the Research Institute, Clinical Research Administration services and how to pay research study bills?
Members of the Clinical Research Administration meet with investigators and research team members to introduce clinical trials processes to them at KUMC. We enjoy meeting with study team members. As part of an introduction to CRA services, various members from the Research Institute will meet with you to discuss new trial start-up, electronic systems used for research at KUMC, budgeting and contracting as well as processing study related bills. If you are a new Investigator, study coordinator, research team member to KUMC, or have been at KUMC and want a refresher, a meeting to cover these topics can be scheduled with an Assistant Director by calling ext. 8-5718.
What does the Clinical Research Administration office need for a new industry-funded study?
Before the CRA will start work on a new study, the essential study documents need to be submitted to our office. These documents include the final protocol, template consent form(s), contract template, and draft budget. Other items that are needed are a copy of the site selection letter from the sponsor/CRO, and regulatory document templates (1572, Financial Disclosure Forms, Protocol/IB signature pages). The start-up process is faster when ALL required documents are provided at the same time.
What does the Clinical Research Administration office need for a new investigator-initiated study?
The CRA can start work on investigator-initiated projects after receiving a final copy of the protocol. Your contact in the CRA will draft the consent form(s) for the study and handle any regulatory documents that may be required. If the study involves filing for an IND, there are additional requirements. Contact the CRA if the study will involve an IND or if you need help determining if an IND is needed. If you are seeking funding for your protocol, or have already contacted an industry sponsor regarding funding or provision of study materials, the CRA can also help facilitate the funding budget and contract needed between the Institution and the funding source.
How do I know who is working on my study?
CClinical Trial Regulatory Specialists and Budget and Contract Specialists are assigned by department/disease group. When the Clinical Research Administration office begins working on a new study you will be contacted by the assigned Clinical Trial Regulatory Specialist and Budget and Contract Specialist. If you have any questions or concerns about who is handling your studies, contact the CRA Assistant Director by calling ext. 8-5718.
When can enrollment start?
Enrollment can start after all the following is completed:
Clinical Research Administration will send an activation email to the investigator/study coordinator/study team members to make them aware that all start up work has been completed and the study is now active at KU and ready for enrollment.
After you have received the activation email from the Research Institute and prior to enrolling any subjects, you must first verify with the sponsor/funding agency to make sure they are ready for you to start enrollment under their protocol.
How do I know the status of my study?
Your assigned Clinical Trial Regulatory Specialist and Budget and Contract Specialist will meet with you and your study team on a regular basis and will provide you with updates on the study set-up process. The CRA encourages investigators and study coordinators to actively meet. If you wish to set up times to meet with your Clinical Trial Regulatory Specialist or Budget and Contract Specialist please contact them via telephone or email.
How can I get the budget information?
Once the study has been activated, the study budget information is provided to the study team in the Activation email. However, during the startup process the Budget and Contract Specialist is in contact with the study team to discuss the budget and any changes or needs they require.
How is the budget created?
The budget is created by the Clinical Trials Budget and Contracts Analyst (BCA) in the Research Institute. The BCA reviews the schedule of events in the protocol along with the sponsor budget template. Once the BCA has reviewed the schedule of events the budget construction begins. The BCA will apply for hospital pricing for items to be billed to the research study only. After the pricing information is obtained, a draft budget is completed and sent to the investigator for review.
Does the Research Institute provide training for study coordinators?
One-on-one training is available for review of the CRA services. The Clinical Trials Educational Lecture Series is conducted on a monthly basis from September to May. In addition, small group workshops for study coordinators and investigators are also available.
Can Clinical Research Administration help write a protocol?
Yes! The CRA is available to help investigators develop investigator initiated protocols and consent forms. For more information about this, contact the CRA Assistant Director by calling ext. 8-5718.
What is the Humans Subjects Committee?
The Human Subjects Committee is the institutional review board (IRB) at the University of Kansas Medical Center. It is the ethical review board responsible for review of all human subjects research conducted at KUMC. The Human Subjects Committee is part of the Human Research Protection Program (HRPP). The HRPP is part of the Office of Compliance.
What is the affiliation with:
The University of Kansas Medical Center (KUMC) has several locations. There are many buildings that are not physically connected to the main campus. Most main campus buildings are within walking distance or are a short drive away.
The University of Kansas Cancer Center and Medical Pavilion, Landon Center on Aging, Hoglund Brain Imaging Center, KU Hospital, the KU Clinical Research Center – Clinical and Translational Science Unit (CTSU) and KU School of Medicine – Wichita & Salina are all affiliated with the University of Kansas Medical Center. Investigators and members of the research study team affiliated with KU can operate at any of the above facilities. Patients can be seen at any of the facilities which are capable of providing care.
All campus addresses are affiliated with the University of Kansas Medical Center. As a research institution, the University has multiple spaces and resources devoted to clinical research. All of these resources are used in the pursuit of satisfying the research mission of the University. The addresses which are associated with the University of Kansas Medical Center are the following:
Main Campus Address:
University of Kansas Medical Center (includes KU Hospital):
3901 Rainbow Boulevard
Kansas City, KS 66160
This is the main campus address. The central mailroom in the main campus will deliver all received documents/packages to personnel in outlying buildings. More specific addresses to other clinics and/or buildings are provided when the investigator’s physical address, study procedure or a piece of equipment being utilized is outside of the 3901 Rainbow Boulevard address.
For example, the Landon Center on Aging houses most of the Neurology department at KUMC and the address for this building would be provided on regulatory and other required documents.
Affiliated KUMC Addresses:
University of Kansas Cancer Center and Medical Pavilion:
2330 Shawnee Mission Parkway
Westwood, KS 66205
University of Kansas – Landon Center on Aging
3599 Rainbow Boulevard
Kansas City, KS 66160
Hoglund Brain Imaging Center University of Kansas Medical Center
3901 Rainbow Boulevard
Kansas City, KS 66160
KU Clinical Research Center – Clinical and Translational Science Unit (CTSU)
4350 Shawnee Mission Pkwy
Fairway, KS 66205
University of Kansas School of Medicine Wichita
1010 N Kansas
Wichita, KS 67214
The Investigational Pharmacy is contained within the KUMC campus at 39th and Rainbow. The main entrance and delivery dock to the campus is the 3901 Rainbow Blvd address. However, in order to facilitate the immediate acceptance and storage of study drugs, the IP has its own delivery dock at:
2015 W 39th Street
Kansas City, KS 66160
At the CTSU:
4350 Shawnee Mission Pkwy
Fairway, KS 66205
The University of Kansas has 4 main sites:
Can you explain the different ways to identify KUMC and KUMC affiliated sites?
KUMC is short for the University of Kansas Medical Center. The KUMC Research Institute is often abbreviated KUMC-RI. The KU Clinical Research Center or CRC, houses the Clinical and Translational Science Unit (CTSU). Many of KUMC’s researchers use the new CTSU building due to its state of the art construction and convenience for subjects. The acronym “KU” may refer to the University of Kansas or the University of Kansas Medical Center. Many of the employees around campus use these acronyms interchangeably.
Why is the focus on IRB submission prior to collecting regulatory documents?
The critical path to IRB approval starts with initial informed consent form review and approval. The new study submission is a vital part of the new study approval and activation process. It is our goal to submit the study to our local IRB as quickly as possible. We focus on this before completing the regulatory documents. There is about a two week gap between IRB submission and receipt of IRB request for modifications, and during this time we prepare and collect regulatory documents. Regulatory documents can be collected quickly and will not negatively impact the new study activation timeline.
Why are one page CVs not pre-populated by KUMC faculty/staff?
Investigators and supporting study staff members put a lot of time into preparing full length CVs and keeping them up to date. We keep all updated CVs on file in our office and supply them when needed. One page CVs create additional regulatory preparation time and burden when required. If a one page CV is required, the full length CV for each study team member that is included in Box 6 of the 1572 will be sent to the sponsor or CRO for them to prepare according to their guidelines. Once KUMC receives the draft one page CVs from the sponsor or CRO, each investigator will review and if acceptable, sign and date the form.
What alternatives are there to using electronic document sharing sites (i.e. Intralinks)?
KUMC does not have the policies and procedures in place to track and maintain documents using the myriad sponsor websites. The CRA follows its own internal standard operating procedures regarding electronic transmission of regulatory and study-related documents. KUMC cannot be expected to set-up accounts on document sharing sites for each study, sponsor, and CRO. The CRA will ship all original documents to the Sponsor designee. We do require an account number or shipping label. If the sponsor does not want original documents mailed to them, we will email documents to sponsor contact. The originals will be maintained in the site regulatory binder until they can be collected by a sponsor representative.
Who is responsible for signing IRB approval letters?
Per the KUMC IRB: The IRB chairperson, IRB administrator, or Director of the HRPP (Human Research Protection Program) has authority to sign IRB approval letters. Approval letters are issued directly from the electronic IRB system. Letters do not contain wet ink signatures.
When are HSC members not present at a meeting?
No HSC member may participate in the HSC’s initial or continuing review of a project in which the member has conflict of interest. If a conflict exists, the Committee member can provide information requested by the HSC but must be excused during the discussion and the vote. Refer to HSC SOP 2.7.III - Review of Research by the Convened Human Subjects Committee (HSC), Quorum for Full-Committee Review.
HSC SOPs are available online by clicking here.
What are the expected turnaround times for:
What are the expected new study activation (including IRB approval, approved budget, approved contract) times for:
The main KUMC campus (Kansas City)
Studies requiring FULL COMMITTEE REVIEW:
Our local IRB has no submission deadlines. The IRB started using an electronic system for submissions in July 2013. The IRB meets every Tuesday. The meeting date to which a study is assigned depends on how long it takes for the IRB to process the new study submission information. This is called the pre-review period. If the IRB has no requests during this time, a study will be assigned to a meeting about two weeks after it is submitted.
Requests for modifications from the HSC are usually received on the Friday afternoon of the same week the study is reviewed.
The study contact in the RI will review the modifications and revise the consent form(s) if necessary. Changes to study documents are sent to sponsor and the KU study team as soon as they are prepared.
If the study received “conditional approval” from the IRB, then the changes to the study will be reviewed by the IRB Chair or designee. Resubmission is dependent on the speed of sponsor and investigator review/approval time as well as any outstanding tertiary committee reviews required (i.e. radiation safety, nursing impact).
If the reviewers “defer” the study, then the IRB has serious concerns about the study which need to be addressed. A deferred study must be resubmitted to the same committee for a second full committee review.
Receipt of the new study approval from the IRB depends on type of review required. If the study only needs IRB chair review, approval can be issued quickly. However, it does depend on when the changes are reviewed and can take longer. If a study goes back for a second full committee review, approval will be received within a few days after the meeting. It is possible the IRB will issue additional requests for changes which would push back study approval.
Studies Requiring EXPEDITED REVIEW:
If a study meets expedited review criteria the submission does not go to a full committee review. The submission can be made at any time and the HSC chair or designee will review at any time. It is difficult to estimate turnaround times for these studies since they depend on a review which does not have a pre-determined scheduled. Expedited studies are usually reviewed quickly.
BUDGET and CONTRACT:
The budget and contract are negotiated in parallel with the IRB process. The Clinical Trials Budgets and Contracts Analyst (BCA) will obtain necessary pricing, draft a budget and obtain PI approval prior to sending a draft budget to the sponsor. After the PI reviews/approves the draft budget, the BCA will start negotiating with the sponsor or CRO.
Contract negotiations occur directly between the BCA and the sponsor or sponsor’s designee. KUMC will not sign the contract until the study is HSC approved and the budget is approved.
Activation of funded studies will occur after the study has HSC approval, all regulatory documents are complete, the budget is negotiated and the contract is fully executed.
It is the target of the Research Institute and the Clinical Research Administration to have new, funded studies activated and ready to enroll in 97 calendar days.
The Wichita Campus
Studies Requiring FULL COMMITTEE REVIEW:
The KU HSC2 (local IRB) meets once a month with the deadline on the 1st Monday of the month and the meeting on the 3rd Monday of the month. Generally, the HSC2 will issue provisos by Wednesday of that week. The CTRS target turnaround time goal is to have them out to the sponsor and PI within 24 hours of receipt. Once responses are received from both sponsor and PI, submission is made to the HSC2. It is reasonable to the expect approval within 3 days. A copy of the HSC deadlines and meeting dates can be found online at http://wichita.kumc.edu/afs/compliance/deadlines.html
FULL COMMITTEE REVIEW, 2 IRB’s:
Studies that utilize Via Christi or WMREF patient care facilities must obtain approval from 2 local IRB's (HSC2 and the appropriate patient care facility). Both meet once per month. The process is to obtain approval from one IRB and then submit to the other. If any additional changes come from the second IRB, an updated submission to the 1st IRB must be made. This process continues until all changes from both IRB’s are approved by both IRB’s.
The submission to the hospital/clinic IRB, called WMREF IRB, is made first. Its deadline is the 1st of every month. The meeting date is the 3rd Wednesday of the month. Generally, provisos are received within a few days. The CTRS target turnaround time for proviso review is 24 hours after receipt.
When do medical licenses expire for MD’s and DO’s?
Medical licenses in Kansas are renewed yearly. In Kansas, MD licenses expire on June 30th, while DO licenses expire on September 30th. The CRA division collects new licenses in June and September every year.
Where is data collected for nursing licenses?
Kansas nursing licenses are no longer issued in paper form. Nursing license information is pulled from the Kansas Board of Nursing website. On July 1, 2010 the KSBN stopped issuing the usual wallet card “license.” License status verification is available online at www.ksbn.org Kansas advance practice nurses, who formerly used ARNP to designate Advanced Registered Nurse Practitioner, will now sign APRN to designate Advanced Practice Registered Nurse. Kansas joins other states across the nation with uniform credentialing.
Where can I find the most current IRB roster and IRB meeting dates?
The CRA stores copies of the most up-to-date information from our local IRB. We can supply the lists upon requests to study sponsors.
When does the KUMC-RI request revised and updated CV’s?
Updated CVs are requested from investigators and study team members when the CVs are more than 2 years old. The KUMC-RI follows industry standards and requires CVs signed and dated within the last 2 years.
How are documents identified on the IRB approval letter?
All documents that are submitted for a new study and any amendment submission are listed on the IRB approval letter. The KUMC IRB uses an electronic submission system. All documents submitted for review are uploaded into the system. The name for the document as loaded into the system is how the document will be identified on the approval letter.
Why doesn’t KUMC use sponsor’s ICF template?
Unless otherwise negotiated under a reciprocity agreement between KUMC and another institution, all KUMC studies are required to use the KUMC IRB consent form template(s) available online at the Office of Compliance website. This is a requirement by our local IRB. Using the KUMC IRB templates maintains consistency in format, layout, and language. It also maintains compliance with federally required consent form elements. The KUMC consent form templates contain all required elements of informed consent reflecting federal, local and Kansas state laws and policies.
Consent forms are ultimately based off of the protocol. The sponsor’s consent form template is used as a reference. If Sponsor’s consent form contains language which follows KUMC IRB guidelines, its language may be incorporated into the KUMC draft consent form. Otherwise, previously HSC approved language will be utilized.
Language required by the HSC can be found in its templates. Please refer to the HSC website for copies of the consent form templates.
Why is CRA staff not listed on the Delegation Log?
CRA staff is employed by the KUMC-RI. CRA staff helps in the administrative management of the study. We are not considered part of the study team. Some duties and responsibilities of CRA staff include interacting with the IRB, assisting with regulatory compliance requirements, regulatory audits, budget oversight and ongoing study maintenance for funded and unfunded clinical research project.