I need some assistance with clinical trials. I have two different questions:

 

1. We have a PI in the Physical Therapy department who will be submitting a clinical device trial next Spring. The PI is currently conducting a reliability and validity study using the device on a healthy population. She would like to include the r/v study on the sick population within the clinical trial next Spring. The r/v study will be identical to the clinical trial, and she does not want to ask the same population to come back twice. Is this an okay approach, or should she be conducting two different studies: one the r/v and the other the clinical trial?
2. We have another PI who may get funding through NIH for a behavioral clinical trial. There is one study site and it is on tribal land. The PI has submitted the protocol to the Tribe’s IRB, as required by the Tribe. The Tribe does not have an FWA. Our office is in the beginning stages of creating a clinical trials program. Is there a way to utilize a commercial IRB for the review and associate with our FWA, or should we bring in a consultant to advise our IRB?

 

If anyone out there has guidance for creating a clinical trials program from the ground up at a PUI, please feel free to reach out directly xxxxxx@wcu.edu We are a very small team, and could use the advice.

 

Jamie Carson

Research Compliance Officer

Office of Research Administration

Western Carolina University

828.227.2921 Camp 110J

xxxxxx@wcu.edu