KUMCRI > Clinical Research Administration > Information for Investigators and Study Coordinators > How We Can Help
How We Can Help
We provide a range of services that are available to all investigators conducting research involving human subjects at the University of Kansas Medical Center. From study startup to study completion, we can help with the following services:
Clinical Trials Budgets and Contracts
The Clinical Trials Budgets and Contracts division manages the contracts required to perform funded clinical trials at the University of Kansas Medical Center. As part of this process, the budget and contract analysts perform an in-depth review of the study protocol to ensure a complete understanding of the needs of the study. We are available to assist with the following:
- Creating and negotiating study budgets
- Negotiating and executing study contracts
- Creating feasibility budgets for potential studies
- Drafting and negotiating research funding agreements and sub-site agreements for investigator-initiated studies
- Drafting and negotiating data use agreements
- Requesting additional funds for activated studies
For information relating to administrative and other fees included in a study budget, please visit the Clinical Trials Institutional Fee Sheet
Greenphire's ClinCard System
Greenphire’s ClinCard System delivers stipends and reimbursements to subjects participating in certain clinical trials. Through the ClinCard System, the Research Institute creates an account for all studies involving subject payment and inputs stipend and reimbursement information. The Research Institute also provides study teams with ClinCard cards, which are similar to debit cards. When payments are offered to clinical trial subjects, the study team provides each subject with a ClinCard card. Subjects may use the card as a check or redeem for cash. If you are a member of a study team and in need of cards, have questions regarding the ClinCard System, or would like additional ClinCard System training, please contact your Budget and Contract Analyst at the Research Institute.
Institutional Review Board Submissions
A team of CRA Regulatory Specialists assists investigators and study teams to obtain all required approvals from the local institutional review board, the KU Medical Center Human Subjects Committee. We provide a full range of services from study startup through study closure:
- Preparation of all applications, including ancillary approval applications; preparation of draft patient consent form(s); completion of electronic submission process; assistance in responding to IRB requests for modification prior to approval
- Ongoing support of approved trials, including submission of any amendments to the study protocol or other materials, submission of continuing reviews (annual or otherwise) through study closure
- In addition, CRA staff will complete all required regulatory documents at study startup and update these documents as needed throughout the trial.
Investigational New Drug (IND) and Investigational Device Exemption (IDE) Applications and Reporting
CRA Regulatory Specialists assist investigators who wish to conduct trials using drugs or devices which may require FDA review and approval. We will prepare required all applications in coordination with the investigator (Requests for IND/IDE exemptions, FDA Form 1571) and submit to the appropriate FDA division. Our team will assist in addressing FDA requests for revision or additional information, and will assist in completion and filing of required reports (SAE reporting, annual reports, etc.)
Recruitment and Retention
Recruitment plans are ideally a part of the protocol and budget planning. Your CTCA will work with you to gather information about recruitment and connect you with the Frontiers Recruitment navigator. Frontiers Recruitment and Trial Innovation Unit (RTIU) is dedicated to speeding trial completion by streamlining trial start-up processes and improving processes for recruiting and retaining participants. More information about Frontiers recruitment can be found at http://www.kufrontiers.org/research-support-services/clinical-studies-and-recruitment-support.html
Studies that are required to be registered (FDA criteria, ICMJE criteria), or are eligible to be registered by the KU Medical Center PI, are added to clinicaltrials.gov using one institutional account. The CRA manages the clinicaltrials.gov KU Medical Center account for non-cancer studies. All studies must be registered under the KU Medical Center Clinicaltrials.gov account. The initial registration and continuing maintenance of each study registration is the responsibility of the "responsible party". The responsible party is either the Principal Investigator or KU Medical Center. The CRA provides assistance in both scenarios. For studies where the PI is considered the responsible party, the CRA provides compliance and technical assistance as requested.
- Create clinicaltrials.gov account for PI to create study registration.
- Notify PI of registration requirements and assist with study record creation and release.
- CRA will notify PI and study team when registrations are out of compliance
- CRA will help study registrations maintain compliance with site requirements over the life of the study, and notify the PI when updates are ready for review/release.
We will help educate and train each user on the clinicaltrials.gov protocol registration system (PRS). The CRA is happy to provide ClincalTrials.gov notifications and compliance and technical support as requested by the investigator.
Velos eResearch (CRIS)
All studies and participants in research in which the patient is consented must be registered in Velos eResearch, an online, Clinical Study Management System (CTMS). It is referred to as the Clinical Research Information System (CRIS) at KU Medical Center.
The CRA will enter all required study data into the system. The CRA can assist with any questions you have about entering patient data or navigating the system. You can also contact CRISsupport@kumc.edu at any time with your questions.
CRIS is a critical component of the research billing cycle at KU Medical Center. In order to help the billing process go smoothly, it is imperative to enter research subjects into the system when hospital services are used. When a study does involve hospital services, the Patient ID field must equal the Medical Record Number. This connects the subject record in CRIS with the O2 (EPIC) record. More information about how to enter data and what data to enter can be found in the CRIS User's Guide.