Children’s Clinical and Translational Discovery Core

Support and advice on the conduct of clinical trials from initial study design and planning through the implementation and interpretation of molecular assays of drug targets and genomic correlates of disease.

Technical support and conduct of biologic assays in support of clinical trials.  This includes, but is not limited to:

• Biological sample analysis
• Cell culture assays
• Western blotting
• Quantitative real-time PCR
• Custom Experimental Design

Access to a variety of human biological specimens from both healthy control participants and patients with a variety of diagnoses.

• Emory University IRB approved Protocol, consent, and assent
• On demand collection of biological samples
• A growing repository of biological samples from both healthy control participants and patients with a variety of diagnoses
• Oversight by the CCTDC Scientific Review Committee - This group provides oversight and guidance for all aspects of the Biorepository

Biospecimen Storage

• All specimens are tracked electronically via the OpenSpecimen Laboratory Information Management System (LIMS).. 
• Samples are stored in secure laboratory spaces at 4˚C, -80˚C, and -150˚C. 
• All storage equipment is monitored 24 hours a day/7 days a week by a Vaisala monitoring system. 
• The CCTDC maintain back-up storage locations in case of individual equipment failure or widespread disaster.  
• Clinical data for samples may be stored in a Research Electronic Data Capture (REDCap) system.

If you are interested in requesting samples for research projects please fill out the Use Proposal Form and Agreement Form and email both forms to CCTDC@emory.edu.

Effective November 4, 2024.

The Emory University Children’s Clinical and Translational Discovery Core (CTDC) is approved to collect 10-50mL of blood per participant.  The CTDC collects whole blood for processing into its components (plasma, serum, or PBMCs).  These processed samples are subsequently stored in the CTDC Biorepository for future distribution to approved investigators.  If an approved investigator requires fresh whole blood for their approved research project, then the following parameters will apply: 

If the requested volume of Whole Blood is <30mL then the CTDC, if needed/able, will collect up to 50mL of blood and distribute up to 30mL of the fresh whole blood to the investigator.  The remaining 20mL of blood will be processed and added to the CTDC Biorepository. The Principal Investigator will be billed for the time required to consent and draw the samples, as well as supplies (including the participant $25 Target Gift Card). Should the PI choose to provide fresh whole blood to CTDC to process and store in the biorepository, the fee will be waived.   

Clinical trials studies located at Children’s Healthcare of Atlanta (CHOA) Center for Advanced Pediatrics (CAP) may utilize the courier service by South Florida Express to transport clinical trial patient samples to Emory University Children’s Clinical and Translational Discovery Core (CTDC) at HSRB. To use this service, please click on the link below to read the protocol:

Protocol

Each sample must be documented on the transport log. Copies of the transport log are available in the Emory lab space on the 5th floor of CAP. Please submit this form every time you leave research specimens for transport. Samples will be picked up by the courier at 3:00 pm daily (Monday - Friday) and brought back to Mimi Le's lab in HSRB by 7:00pm on the same day.

Please fill out this form in addition to the physical sample transfer log when requesting samples to be couriered between CAP and HSRB.

Support and advice on the conduct of correlative biology studies associated with clinical trials from initial study design and planning through the implementation and interpretation of molecular assays of drug targets and genomic correlates of disease.

Academic Biospecimen Processing Rates (effective 2/1/2024):

Kit based studies, or custom services, are billed according to time.  Investigators must consult Dr. Mimi Le to determine pricing.  Custom services utilizing core supplies will also be billed the market supply rate*.  

• Plasma/Serum & Others** = $20, per unit
• PBMC*** = $36, per unit
• Consultation/labor = $43, per hour
• Long-term storage = $9/box/year

* Kit based studies, or custom services, are billed according to time. Custom services utilizing core supplies will also be billed the market supply rate. Investigators must consult Dr. Mimi Le to determine specific pricing before initiating a new study.

** Plasma/Serum & Others includes the standardized processing of Plasma, Serum, Biopsy, Blood Spot Card, Saliva, Stool, Urine and Fresh Whole blood. Extra processing time and supply cost from a specific request will charge with the hourly rate and market supply rate.

*** PBMC includes PBMC viably frozen sample, plasma aliquot sample and viably frozen + plasma aliquot sample.

Please contact Mimi Le for industry rates.

Core Facilities are required to review rates on an annual basis and rates are subject to change.  Users with long-term projects should anticipate some increase in cost over the course of the study and budget accordingly.  

Subsidy Policy

The Emory University Children’s Clinical and Translational Discovery Core (CTDC) is generously supported by the Emory University Department of Pediatrics and Children’s Healthcare of Atlanta. 

• We offer generous subsidies off the list price to Department of Pediatrics researchers who are leading investigator-initiated studies.  
• Additional consideration will be given to investigators outside of the Department of Pediatrics who are conducting investigator-initiated research that may have an impact on pediatric patients. Investigators outside of the Department of Pediatrics who would like to request a subsidy should send an email request to Dr. Mimi Le stating the project title, funding source, and a brief justification of how the research is child health related. These requests will be evaluated by the CTDC Operations team. 
• Each investigator may receive up to, but not exceeding, $5,000 in subsidies each fiscal year.
• Subsidies are not provided for any industry initiated studies.

Billing Policy (effective 9/1/2024)

New and existing projects are required to provide a non-sponsored/backup speedtype to avoid lapse of payment. Non-sponsored or backup speedtype will only be used when the study speedtype is in the process of renewal or the grant period has ended to avoid lapse of payment. In the case that the primary or backup speedtype is not active to pay for services performed by the CTDC, the division will be responsible for payment consistent with Emory fiscal policies. Failure to pay for overdue services after 2 months may results in suspension of core services until the invoices are paid in full.

Citing the Children’s Clinical and Translational Discovery Core 

The Children’s Clinical and Translational Discovery Core is generously supported by Children's Healthcare of Atlanta and Emory University.

When presenting or publishing work completed using the core, please include "Children's Healthcare of Atlanta and Emory University's Children’s Clinical and Translational Discovery Core" in the acknowledgments.

To determine if you should use “Children’s Healthcare of Atlanta” in your author affiliations, please see guidelines here.

The Clinical and Translational Discovery Core (CTDC) is a shared resource for Atlanta area child health researchers. The CTDC supports clinical trials with sample processing, shipping and receiving, correlative biology studies, and long-term biobanking of a wide variety of human tissues for future research. The lab contains six -80^oC freezers and one -150^oC freezer contained in a secure, key card restricted, laboratory space. All freezers are under preventative maintenance contracts and monitored 24/7. The CTDC staff are notified in the event of temperature excursions and maintains access to backup storage units in the event of a catastrophic failure. Subsidized by Children’s Healthcare of Atlanta, the CTDC provides very competitive rates for biorepository studies. The CTDC is able to serve as the central biorepository for multicenter clinical studies.