Clinical Research Resources and Facilities Core

Our goal is to build an island-wide network of culturally competent clinical research resources and facilities that promote the sharing of ideas and incorporating community priorities into the conduct of clinical and translational research. The contribution of our CRRF Core will be the expanded access to a resident population of Caribbean Hispanics, along with the facilitation of clinical and translational research by Hispanic investigators and consequently an expected increase in the number of active investigators in this group. This contribution will increase the identification of ethnic-specific differences and thus will improve the generalizability of findings.

The expanded access to this population through the Alliance network will increase the limited understanding that currently exists about differences among Hispanic subgroups. An added benefit will be to enhance the competitiveness for funding of minority investigators by providing the necessary research infrastructure and resources that are often limited and inadequate in resource-limited institutions like those in Puerto Rico.

• Specific Aim 1. Establish an integrated network of clinical and translational research resources and facilities to enhance cost-effective, multidisciplinary and inter-disciplinary research, in health conditions prevalent among Hispanic populations.
• Specific Aim 2. Facilitate and increase the recruitment and retention of research participants from underserved Hispanic communities.
• Specific Aim 3. Ensure that clinical and translational research with human subjects is safe and of the highest quality.

From 2010 to 2019 the Clinical Research Resource and Facilities Core (CRF) provide clinical support for 297 investigators from the consortium institutions under the Puerto Rico Clinical & Translational Research Consortium (PRCTRC). This support resulted in 30 grants and over $7,119,266 of funding obtained.

• Access to the ALLIANCE facilities after traveling during the COVID-19 pandemic
• Adverse Event Reporting to the Hispanic Alliance for Clinical and Translational Research (Alliance)
• Blood Pressure (BP) Assessment
• Corrective actions for IP misadministration
• Disposal of Study Medications (Investigational Products)
• Education and Training for Investigators, Research Team Members, and Alliance personnel
• Electrocardiogram Procedure (ECG)
• Expired Institutional Review Board (IRB) Approval – Continuation of Current Participants
• File of Inactive Research Studies Documents
• Infant Saliva Collection Method
• Informed Consent Process
• Investigational Product (IP) administration
• Loop Electrosurgical Excision Procedure (LEEP)
• Lumbar Puncture Procedure
• Monitoring Visits
• Personnel and Signature Log
• Phlebotomy in Pediatric Research Subjects
• Phlebotomy in Research Subjects
• Review Process of Research Studies that Request the Hispanic Alliance for Clinical & Translational Research (Alliance) Resources and Support
• Storage of Investigational Products (IP)
• Study Initiation Meeting
• Temperature monitoring of Investigational Products (IP) storage areas
• Transport of Samples
• Urine Sample Collection
• Vulvoscopy and Punch Biopsy

Our CRRF Core provides infrastructure support, personnel, and training in the science of clinical and translational research, leveraging resources across the Alliance to enhance research capacity. Besides our clinical services, we also provide services as:

1. Cost Recovery System
2. Alliance Volunteer Registry
3. Network of Participating Center and Units (CRUs)
4. Network of Clinical Research Units
5. Mobile Translational Research Service (MTRS)
6. Tracking of usage and dissemination of available resources
7. Recruitment and Retention of Underrepresented Investigators
8. Protocol Review and Prioritization
9. Compliance with Good Clinical Practice (GPC) and Research Guidelines

Our Nurse area if fully packed with:

• 10 examination rooms
• 2 procedures rooms
• 3 vital sign/weight/height room with double door-controlled access
• Working area for Study Coordinators
• Nursing Station
• Investigational Products and Laboratory Kits storage area.

We also have a clinical and dental equipment available that include:

• Electronic and manual blood pressure machines
• Electronic oral thermometers
• Weight scales with stadiometers
• Portable weight scales and stadiometer
• 12 Lead ECG machine
• Portable and wall units ENT sets
• Blood glucose monitor
• Megathoscopes
• LifePak500 Automated External Defibrillator
• Pediatric and Adult Emergency carts
• Two Ultima 2 Dentech dental chairs
• High performance Tuttnauer autoclave steam sterilizer
• Biasonic UCC 100 and UC 3000 equipment
• Individual locked room temperature cabinets
• 1 refrigerator (2°-8° C)1 freezer (-20° C) and 1 freezer (-80° C) for Investigational Products (IP) storage
• 24hr time Recorder for refrigerator temperature
• Record room with double controlled access

All of this infrastructure is part of UPR-MSC Clinical Research Center, which is housed within the Alliance, and has served as the foundation of the Clinical Research Facilities in the Puerto Rico Clinical and Translational Research Consortium (PRCTRC) for the last 10 years.

The University Central del Caribe (UCC) has a two-floor clinical treatment / research facility with a total of 4,000 sq. feet that is used directly for Alliance related research. The CRRF facility area have a 1500 sq. ft. area, which includes an administrative area, ten patient care rooms, records storage area with controlled electronic access (locked gates and security cameras), providing ample security for the participants and confidentiality protection for the sensitive data, an examination room, and a phlebotomy area for confidential human subjects’ interviews, physical evaluations, evaluation, and consent process. It is also supported by a clinical laboratory and research laboratories that have special containment facilities with Biosafety level 2 (BL-2) rooms. HIV and HCV identification and quantification, HIV-1 serology, cytokine/chemokine determination, and flow cytometry analyses are performed.  The laboratories are also equipped to perform quantitative real-time PCR and Western blot and other cell and molecular biology techniques.

The hospital and clinics serve the Bayamon Health Region of Puerto Rico. This health region is composed by 10 municipalities that include: Bayamon, Toa Alta, Corozal, Vega Alta, Toa Baja, Naranjito, Orocovis, Cataño, Barranquitas and Dorado. Its estimated population is 581,564 inhabitants according to the year 2013 estimates from the Puerto Rico Census Office. Researchers are provided assistance by the Data Management and Statistical Research Support Unit that has four servers, 24 desktop computers, 17 laptop computers, nine printers, and two Scanners. The computer are equipped with SPSS 14, SAS 9.1.3, STATA 10, Stat Transfer 9.3, Oracle lOg, SPSS Data Entry Builder 4.0, Microsoft Office 2007, Approach 97, Visual Studio 2005, Adobe Acrobat 8.0 Professional, Adobe Photoshop CS3 Extended, Adobe Illustrator CS3, Adobe Flash CSS Professional, Macromedia Studio 8.

All of these facilities have provided support for integrated clinical and translational research projects at UCC. They will remain as resources available to clinical investigators from the participating institutions, in their interests to conduct clinical and translational studies. For more information visit UCC-Reasearch

For clinical research and services, the institution has two major areas; the Ambulatory outpatient Clinic building (now the PMSF Wellness Center; 6,300 sq. feet) and the Ambulatory Center for Medical Research (CAIMED) building. The CAIMED unit is the designated site at the institution to run clinical protocols in collaboration with pharmaceutical companies. Currently, the CAIMED Unit conducts over 45 individual protocols in a variety of areas including diabetes, oncology, urology, vaccine safety, hypertension, infectious diseases, etc.

 For more information visit CAIMED-PHSU

The Hispanic Alliance for Clinical & Translational Research (Alliance) provides transportation services for the outreach to the community for study recruitment and collection of study-related data and specimens.

To request this service, please complete the Transportation Services Request Form and the Alliance Official Vehicle Use SOP and send it to Lic. Aracelis Arroyo-Mojica at aracelis.arroyo@upr.edu. The off-sites visits are scheduled weekly and for these visits, official transportation is provided.