Frequently Asked Questions

What are the services that are offered by the Clinical Research Administration office?
How can I learn about the Research Institute, CRA services and how to pay research study bills?
When should a new protocol be turned in to Clinical Research Administration to meet the Human Subjects Committee Deadline?
What does the Clinical Research Administration office need to prepare a new submission?
How do I know who is working on my study?
When can enrollment start?
How do I know the status of my study?
What happens to the Human Subjects Committee approval once it is granted?
How can I get the budget information?
How is the budget created?
Does the Research Institute provide training for study coordinators?
Can Clinical Research Administration help write a protocol?
What is the difference between the Human Subjects Committee and Clinical Research Administration?

What are the services that are offered by the Clinical Research Administration office? 
See our website for a listing of services.
http://www2.kumc.edu/researchinstitute/cra/crainfoforinvestigators.htm

How can I learn about the Research Institute, Clinical Research Administration services and how to pay research study bills?
A meeting(s) can be scheduled with the Division Director or Research and Program Officer by calling ext. 81484 or 81242. 

When should a new protocol be turned in to Clinical Research Administration to meet the HSC deadline?
To allow the investigators ample time to review the draft consent form the Clinical Research Administration office sets a deadline 10 working days prior to the HSC deadline. This date is posted on the Clinical Research Administration receiving box.

What does the Clinical Research Administration office need to prepare a new submission?
The most important items are the final protocol and a telephone number or email address of the sponsor contact. Essentially, provide the Clinical Research Administration office with all documents (except the case report forms). Other items that are needed are a copy of the cover letter received from the sponsor, a copy of the draft consent and/or the consent form on disk, 1572 information, Financial Disclosure Forms, Protocol signature pages etc. 

How do I know who is working on my study?
Clinical Trials Administrators are assigned by department/disease area. When the Clinical Research Administration office begins working on a new study you will be contacted by the assigned Clinical Trials Administrator

When can enrollment start?
Enrollment can start after: 
1. Human Subjects Committee approval is granted
2. The Investigator, the Research Institute and the funding agency of the study have signed the contract or a grant award letter is received and approved by the Research Institute
3. All administrative paperwork has been completed.

Clinical Research Administration will send an email to the Investigator/study coordinator to make them aware that all paperwork has been completed and enrollment is ready to begin. Although, you should always check with the sponsor/funding agency to make sure you can start enrollment.

How do I know the status of my study?
Your assigned Clinical Trials Administrator will be meeting with you and your study team on a regular basis and will be providing you with updates on the study set-up process.

What happens to the Human Subjects Committee approval once is it granted?
When the Human Subjects Committee approval is received in the Clinical Research Administration office it is faxed to the sponsor. The information sent to the sponsor includes the original cover letter submitted to the Human Subjects Committee, the approved consent form, the Report of Action, and the Human Subjects Committee supplement form (if needed) that lists any additional attachments that were submitted with the original submission.

How can I get the budget information?
The Research Institute can release budget information to the coordinator only after receiving approval from the Investigator of the study. An authorization form is found at http://www2.kumc.edu/researchinstitute/spa/spaforms_internal.html

How is the budget created?
The budget is created by review of the schedule of events in the protocol. Once the Research and Program Officer has reviewed the schedule of events the budget construction begins. The Research and Program Officer will apply for discounts for items billed to the research study only. Once the discounts are back, 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 and review of the Self Review Checklist (SRC) for the Case Report Forms and the Self Review Checklist for the regulatory binder. 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 Division Director and Research and Program Officer are available to help investigators develop investigator initiated protocols and consent forms. A protocol template can be found at the following website: http://www2.kumc.edu/researchinstitute/cra/crainfoforinvestigators.htm

What is the difference between the Humans Subjects Committee and Clinical Research Administration?
The Human Subjects Committee is the ethical review board responsible for review of all research that is conducted at the University of Kansas Medical Center. 

The Human Subjects Committee is under the direction of the Associate Vice Chancellor for Compliance, John Finley JD. 

The Clinical Research Administration office is a central office within the university that assists the investigator/study coordinator with consent form writing, budget preparation, obtaining discounts/study billing number, submissions to the Humans Subject Protection Program such as Human Subjects Committee, Institutional Research Safety Committee, Conflict of Interest Committee, Research Compliance, and Radiation Safety Committee, IND submissions, quality assurance services, education, training and protocol development.. 

The Research Institute is under the direction of the Vice Chancellor for Research Administration, Dr. Paul Terranova.