Research Flow

Study Design

Clinical Research Unit

Biostatistics Collaborative Core

The CRU provides the tools, training and guidance to properly conduct clinical research.  The CRU has dedicated staff of research professionals who are skilled in several aspects of clinical research, including study startup, project coordination and regulatory oversight. In the initial phases of investigator-initiated research studies, the unit along with the Biostatistics Core, provides support on study design, biostatistics, epidemiology and health services research consultation. 

CRU Services Request

CRU Application Process

Budget Development

The CRU Director develops a budget to identify the charges that will be assessed upon successful service delivery. The budget will include a study start-up fee and any additional approved fees based on the needs of the researcher and a time required to provide selected services.

Letter of Support

The CRU Director provides a letter of support upon a mutual agreement with a researcher. The letter of support notes the collaboration between the CRU and a researcher as well as explains what services are offered for a particular study.

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Budget Submission

Sponsored Programs - Novelution

Contract Administration

Sponsored Programs - Contract Services

Regulatory Assistance

Clinical Research Unit

Institutional Review Board (IRB)

The CRU staff includes project leaders and study coordinators to provide human subject’s research protection and regulatory assistance and help investigators achieve their research goals while upholding compliance with all regulations and standards. 

IRB Submission & Approval

Institutional Review Board - Submitting to the IRB

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Recruitment

Clinical Research Unit

The CRU is a state-of-the-art core research space specifically designed to conduct clinical trials, clinical research including longitudinal studies, and patient-outcomes-oriented research projects. The CRU closely collaborates with the physicians’ offices and community organizations for recruitment purposes. The clinic is staffed with skilled research coordinators capable of implementing multiple recruitment strategies, including email solicitations, flyers/brochures distribution, in-person/virtual presentations, and social media advertising.

Data/Specimen Collection

Clinical Research Unit

The nursing team members at the CRU are skilled in advanced assessment, phlebotomy, administration of various routes of medication, electroencephalogram, and pulmonary function testing. The CRU, located on the Boca Raton campus, has three exam rooms, one private cognitive/consultation room and a waiting room for participants and family members.  The CRU staff is trained to perform consenting, cognitive testing, and other study specific interventions.

Data Management

Biostatistics Collaborative Core

Specimen Storage/Shipment

The CRU has multiple storage options, including ambient, 4°C, -20°C, -80°C, -150°C. The CRU maintains the cold chain custody of samples in a frozen and/or refrigerated state throughout storage. All freezers and refrigerators as well as ambient conditions are monitored electronically 24/7. In the event of an emergency, the CRU is equipped with generators for back-up power.

The CRU staff stores biological specimens safely and securely according to the type of sample, and according to protocol’s instructions and storage unit. The CRU uses a biorepository and freezer inventory program, called Freezerworks, to track existing specimens stored in the freezers. The software ensures the CRU’s adherence to best practices and regulatory requirements. Freezerworks allows the staff to effectively track sample shipping, pooling, and aliquot linage. It provides the CRU with a complete, configurable annotation of samples and aliquot records. It also prevents unauthorized access to samples and participants’ data.

IRB Continuing Review/Amendments

Institutional Review Board – Submitting to the IRB

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Data Security & Storage

The CRU has designated locked office spaces to store the hard-copy data. The staff ensures that individual subject records are stored in study binders, in the locked storage cabinets. The CRU also prepares all study files for archiving. An outside company is being utilized to store study-related documents offsite in a secure manner.

Return of Supplies/Equipment

Upon completion of the study, the CRU destroys or returns all study-related materials (i.e. unused study lab kits, data collection forms, recruitment materials) to a researcher. Any equipment on loan is returned as well, and all documents are properly filed in the regulatory binder.

IRB Final Report Submission

Institutional Review Board – Submitting to the IRB