NCRC Protocol Submission

NCRC Protocol Submission

Procedure to Assess and Select NCRC Clinical Trials

The Division of Nephrology at the University of Virginia established the NCRC to facilitate adult and pediatric clinical research in an outpatient setting. Our mission is to assist clinical investigators conducting their clinical studies by providing scientific input and feedback and also to assist them conducting their studies. The research coordinators at the NCRC have many years of experience in conducting both investigator-initiated and large multi-center industry-sponsored trials.

Clinical Director:

  • Kline Bolton, MD

 

Assistant Director:

  • Kambiz Kalantari, MD

 

Administrator:

  • Robert Young

 

Grants & Contracts Manager:

  • Ruthie Cragg

Scientific Review Committee:

  • Kline Bolton, MD
  • Kambiz Kalantari, MD
  • Mark Okusa, MD
  • Mitchell Rosner, MD

Research Coordinators:

  • Lisa Johnson
  • Nino McHedlishvili

All investigators intending to use NCRC resources are required to complete the online NCRC Study Request application form.

The requests will be reviewed by the scientific review committee first. In case of industry-sponsored studies, the committee will decide on the scientific merit of the protocol and based on the scores given to each protocol and according to the priorities of the Nephrology Division, decision is made to accept or reject a study. For investigator-initiated studies, the committee will try to assist investigators in refining their protocols and assure the highest scientific quality of each study. A priority score will be assigned to each protocol.

Once a study is approved by the scientific committee, the protocol will be reviewed by a second committee composed of the NCRC administrator, grants and contracts manager and coordinators. For industry-sponsored trials, budget and details of the study protocol will be negotiated with the industry representatives. If appropriate, depending on the coordinator time available, study will be accepted. For investigator-initiated studies, if not funded by NIH or other sources, the grants and contracts manager will assist the investigator in finding potential funding sources. These include the National Kidney Foundation, American Society of Nephrology, American Heart Association, American Diabetes Association, etc. The group will then assess the requirements of the study and resources available at NCRC and will inform the investigator of the extent of help available at the NCRC.

For industry-sponsored studies with a high priority scores and funded investigator-initiated studies, such as those funded by the NIH, the administrative group will try to utilize all the resources available to conduct the study such as utilizing part time coordinators.

For investigator-initiated studies, the investigators will be referred to resources available at the University of Virginia to assist with the conduct of clinical research. These include the Human Investigation Committee, The General Clinical Research Center and the Clinical Trials Office. The NCRC coordinators are not expected to complete applications for HIC; these tasks are expected to be completed by the investigators.

Helpful links

HIC
UVa Clinical Trials