Duke Early Phase Clinical Research: Services

Duke Early Phase Clinical Research: Services

Our services are offered on-site at the Duke Early Phase Clinical Research Unit at Duke University Medical Center.

Research Participant Recruitment Core

Recruitment services are available for all studies conducted in the Duke Early Phase Clinical Research Unit. We have a dedicated recruitment team that develops recruitment action plans and advertising materials for IRB submission, coordinates media efforts, and manages incoming calls for potential participants.

Laboratory Specimen Collection, Processing, and Storage

Our processing laboratory is staffed by experienced technicians who can perform specimen collection in addition to point-of-care testing. They expertly handle all facets of specimen management, including a robust chain of custody. Our staff follows study-specific protocols to process, aliquot, and store samples. Laboratory equipment is routinely monitored and maintained. Capability for short-term storage (up to 90 days) or immediate shipment to central laboratories is available.

Medical Staff Coverage

The Duke Early Phase Clinical Research Unit is capable of providing 24/7 medical coverage, which includes an on-site respiratory therapist. As a hospital-based unit, we have immediate access to the full complement of emergency-response capabilities of Duke University Hospital, such as code teams, emergency department, and a 900+ bed quaternary care facility.

Nursing

Our research nursing staff is composed of fully credentialed Duke Hospital registered nurses, certified/registered medical assistants, and health unit coordinators. Nursing team members are skilled in advanced assessment, phlebotomy, IV therapy, ECG, and chemotherapy administration and are BLS-, ACLS-, and PALS-certified.

Nutrition

Our nutrition team works within a research kitchen and is capable of providing specialized diets and services that include controlled-nutrient and metabolic diets.

Pharmacy

We work in close collaboration with the Duke University Hospital Department of Pharmacy Investigational Drug Services to provide comprehensive management of all facets of study agents, including ordering, IVRS/IWRS/randomization, receipt and secure climate-controlled storage, preparation, accountability and records retention, returns/destruction, staff education and training, and a robust quality-management system.

Project Management and Research Coordination

The unit provides an experienced staff of project leaders, study coordinators, regulatory coordinators, and clinical trial assistants who are dedicated to helping investigators accomplish their research goals while maintaining compliance with all applicable regulations and standards.

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