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Please remember to cite the Shared Resources!

Research reported in this publication was supported by The Ohio State University Comprehensive Cancer Center and the National Institutes of Health under grant number P30 CA016058.

We thank the XX Shared Resource at The Ohio State University Comprehensive Cancer Center, Columbus, OH for (XX)

Meet the Team (back to top)

Shared Resource Director: Dwight Owen, MD (dwight.owen@osumc.edu)

CTPL Assistant Director: Megan Jukich, MA (megan.jukich@osumc.edu)

CTU Nurse Manager: Carrie Hennelly, MSN, RN, ACRP-CP (carrie.hennelly@osumc.edu)

To further our shared goal of translating scientific knowledge into novel therapeutics, the OSUCCC offers investigators access to a network of clinical research laboratories dedicated solely to the collection of high-quality research biospecimens. The Clinical Trials Processing Laboratory (CTPL) is one of the many services provided through the Clinical Trials Office (CTO) to assist in the initiation and conduct of oncology clinical trials. The CTPL maintains 6 locations throughout the university, each adjacent to key patient care locations:

The CTPL enables OSUCCC–James investigators to conduct successful phase I - phase III clinical translational research in a methodologically sound, expedient, and cost-effective manner. Each laboratory provides research support for a specific patient care environment or specialty team. The newest addition to the CTPL network is a lab site immediately adjacent to the CTU on the 7th floor of the new James Outpatient Care building. The CTU is a 12-room patient care unit specializing in high-complexity care of clinical trial patients. In this environment, patients have access to early-stage therapeutics requiring intense monitoring or complex correlative sample collections.

The CTPL enhances research quality by providing dedicated staff for high-volume procurement, processing, storage, delivery and shipment of research specimens. CTPL experts collaborate with other OSUCCC Shared Resources, including Pharmacoanalytic (PhASR), Leukemia Tissue Bank (LTB), Clinical Translational Science (CTSSR), and Recruitment, Intervention and Survey (RISSR). Collectively, these shared resources provide researchers with end-to-end support for clinical trials; from protocol development and review, to feasibility assessment, specimen processing, and sample distribution to internal and external research laboratories.

Available Services (back to top)

• 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.
• CTPL Primary Reviewer: assigned for every protocol supported by CTPL, develops protocol-specific instructional material for use by all CTPL staff detailing research specimen collection, processing, storage and shipment requirements.
• Research Specimen & Documentation Collection: services regarding dosing and specimen collection times for all patients treated in the CTU.
• Protocol & Laboratory Manual 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: Once the study opens to accrual, the clinical research nurse or coordinator provides in-service training for the CTU nurses. CTU nurses treat, and monitor patients treated on protocols requiring more intensive sample collection and monitoring. 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 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 of The James.
• Instrumentation: Ultra-low upright freezers (-80C and -20C) and refrigerators for specimen storage monitored around the clock by REES electronic temperature monitoring system, centrifuges, biosafety cabinets, and microcentrifuges (biosafety cabinets and microcentrifuges not available in all CTPL lab locations). 

Click here for full list of services and fees

Education Resources (back to top)

As a part of onboarding procedures, the availability of CTU and CTPL resources are described in detail for physicians who are new to the CCC. These include (as described above) pre-study consultation, costs, and on-study activities.

For investigators writing their own protocols, the Correlative Specimen Training Guide will discuss factors to consider when planning, writing, and conducting a clinical protocol with a correlative specimen component. It contains the suggested format by the NCI for writing the protocol's correlative specimen section and a checklist which investigators can use to ensure all required information is detailed in the protocol.

Please remember to cite the Shared Resources!

Research reported in this publication was supported by The Ohio State University Comprehensive Cancer Center and the National Institutes of Health under grant number P30 CA016058.

We thank the XX Shared Resource at The Ohio State University Comprehensive Cancer Center, Columbus, OH for (XX)

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