The Clinical Treatment Unit and the Clinical Trials Processing Laboratory Shared Resources (CTU/CTPLSR) enable investigators at The Ohio State University Comprehensive Cancer Center to conduct successful Phase I and Phase II clinical translational research in a methodologically sound, expedient and cost-effective manner.
The CTU/CTPLSR offers the following services:
A CTU Lead Nurse: assigned for every protocol conducted in the CTU, works closely with Clinical Trial Office (CTO) nurses and coordinators to develop flow sheets for capturing vital sign, dosing and specimen collection time information
Research Specimen & Documentation Collection: services regarding dosing and specimen collection times for all patients treated in the CTU
Protocols Review and Consultation: for investigators regarding correlative specimen aspects of protocol study design
Budget Preparation: for correlative research specimen activities
Specimen Collection Kit Storage: for kits received from non-OSU sponsors
Collection Kit Preparation & Labeling: for each study visit
Specimen Procurement: in conjunction with multiple clinical units and research staff
Specimen Processing & Storage: according to protocol or laboratory manual
Specimen Preparation: for delivery to local laboratory or shipment to outside laboratories
Specimen Shipment: to appropriate sites
In-Services for Clinical and CTO Staff: regarding correlative research specimen collection and processing requirements
Pre-Study Support Activities: CTU/CTPLSR experts work closely with investigators, CTO staff and research staff to ensure requirements for monitoring, toxicity assessment, laboratory testing and correlative specimen collection, as well as handling, processing, storage and shipping, are well-defined early in the protocol lifecycle.
Study Support Activities: CTU/CTPLSR experts treat and monitor patients treated on protocols approved by the CTU Review Committee. In collaboration with the research nurse/coordinator, the lead CTU nurse provides in-service training for the CTU team. Once the study opens, the research nurse or coordinator works closely with the CTU scheduler and CTU charge nurse to schedule protocol-specified visits.
The CTU offers monitoring and collection of multiple biological specimens at the specific timed intervals after drug administration and provides documentation of the same.
The CTPL procures, processes and stores research specimens collected within the CTU and other ambulatory and inpatient units within The James.