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
