The PRCTRC facilities at the UPR-MSC has 14,000 sq. feet that include examination, procedures and infusion rooms as well as the equipment necessary for the protocol procedures. The nursing services include: daily preparation of the examination, procedures and infusion rooms as needed, measurement of vital signs according to each protocol, phlebotomy, 12-Lead ECG. Assist in medical procedures such as, lumbar puncture, pelvic exam, biopsy, High Resolution Anoscopy, and physical examination. Anthropometric measures, timed sampling (i.e., pharmacokinetics studies), intravenous study medication, infusions, data collection in the source documents, evaluation and follow-up of any adverse event of the subjects, nursing off sites visits, when is needed to comply with the protocol goals.
The PRCTRC enhances and improves the utilization of new and existing resources. The PRCTRC will provide convenient one-stop information and coordinating center for investigators. The services are being coordinated by Madeline Maldonado-Urbina, MPH, CG, who has been involved in the UPR-MSC. Ms. Maldonado will coordinate among other activities the IPPCR efforts to accomplish the 1st specific aim to strengthen and expand the current outpatient-based clinical research facilities, resources and support available through the PRCTRC member institutions and its collaborative partners.
All the equipment is calibrated and certified by an authorized company. These documents are available upon requested.
The Puerto Rico Clinical and Translational Research Consortium (PRCTRC) Participants Clinical Interaction Resources (PCIR) nursing staff is composed of a nurse supervisor, Barbara-Guzman, BSN, RN, MPH and two research nurses, Sheyla Garced-Tirado, RN, MS and Ladimila De Lima-Payero, BSN, RN. The nursing staff is highly qualified to perform the procedures required by each protocol. The working hours for clinical procedures begin at 7:00 am until 5:00pm. Monday thru Friday. However, any protocol that requires after hours visits (i.e., pharmacokinetics studies) can be performed by previous arrangement. Once the application process of the protocol is successfully completed, if the nursing services are required, the Principal Investigator and his/her research staff must meet with the nursing staff to provide an initiation meeting. In this meeting the protocol will be discuss and the nursing services will be identified according to the clinical procedures to be perform. Also, the nursing staff will offer additional services like facilities of record room and study medication storage with daily temperature recording.
Transportation services provided for off-sites visits, pick-up and delivery of clinical research specimen samples. To request this service, please complete the Transportation Services Request Form and send it to Ms. Madeline Maldonado at firstname.lastname@example.org. The off sites visits are scheduled weekly and for these visits official transportation is provided.
- Access of the External Research Staff
- Consent for Medical Services
- Deviation in Temperature of Study Medications Storage Areas
- Disposal of Study Medications
- File of Inactive Research Studies Documents
- Intervention From External Research Personnel to Perform Procedures to Participants
- Non-serious Adverse Event
- Off Site Visits
- Phlebotomy in Control Subjects for Research
- Phlebotomy in Research Subjects
- Receipt and Sending of Documents via Facsimile
- Removal of Research Source Documents
- Serious Adverse Event
- Storage of Investigational Drugs
- Telephone Use
- Storage of Investigational Equipment and Material
- Procedure Access of External Research Staff to the PRCTRC
- Phlebotomy in Pediatric Research Subjects
- Monitoring visits in the PRCTRC
- Informed Consent Process
- Seven examination/study rooms. Two of them are equipped for gynecologic procedures.
- Two infusion rooms with capacity for subjects in studies requiring prolonged monitoring, IV medication administration or PK sampling.
- One procedure room equipped to perform neuromuscular evaluations.
- Two Vital Signs/Two Phlebotomy areas.
- Two nurses stations.
- Electronic and manual blood pressure machines.
- Electronic oral thermometers.
- Weight scales.
- Portable weight scale.
- 12 Lead ECG machine.
- Portable and wall units ENT sets.
- Blood Glucose monitoring system.
- IV pump-Abbott Life Care 5000 Infusion System Certified.
- LifePak500 Automated External Defibrillator.
- Pediatric and Adult Emergency Carts.
- Storage medication area with access code, lock cabinets and refrigerator.
- Room temperature and refrigerator thermometers.
- 24hr time Recorder for refrigerator temperature.
- Megathoscoper in each examination room.
- Record room with double controlled access.
- Storage facilities for laboratory kits.
- Medication storage facilities with room temperature and refrigerated study drug
- Locked medicine cabinet with an additional refrigerator.
- Two Ultima 2 Dentech dental chairs
- Fax machine for private medical information.
Universidad Central del Caribe Facilities for Clinical Research (UCC)
The UCC has a two floor clinical treatment / research facility with a total of 4,000 sq. feet that will be used directly for PRCTRC related research. The facility has two offices, ten patient care rooms, a reception area, a meeting room, one large and five small storage areas, and a patient records room. This facility is 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. Also, laboratories are equipped to perform quantitative real-time PCR and Western blot and other cell and molecular biology techniques.
The University is next to the Ramon Ruiz Arnau University Hospital. The hospital has five floors and a hundred beds for treatment of internal medicine, surgery, gynecology, orthopedic, pediatric and family medicine patients. The hospital has clinics in endocrinology, nephrology, dermatology, neurology, hematology, cardiology, and rheumatology. A non-invasive Cardiology Laboratory is located in the Department of Internal Medicine and an Electron Microscopy Facility in the Department of Pathology. The Immunology Clinic, a comprehensive clinical care unit, is located within the premises of the UCC campus. The Clinic treats the majority of HIV infected patients of the Bayamon Health Region with ambulatory and in-patient health care units in which patients receive the necessary clinical, laboratory and pharmacologic services required for the evaluation and therapy of HIV infection. Emergency room services are available along with the support infrastructure of counselling, social services, nutritionist services and health education, amongst others. This Clinic is used by UCC researchers who require private interviews with patients, accessibility to the clinical records of research subjects, and help in the procurement of blood samples.
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, Catano, 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.
The UCC Biomedical Sciences Building houses 28 individual research laboratories, two areas for the Common Instrumentation Facility, a Cell and Tissue Culture Laboratory, an Optical Imaging Facility, a Protein/Nucleic Acid Core Laboratory, an Immunoretrovirology Laboratory with Flow Cytometry and Nucleic Acid Amplification and Detection Units, an Immunocytochemistry and Electrophysiology laboratory, a Behavioral Testing Facility, a Biomedical Proteomics Facility, that processes human samples in the search for biomarkers.
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.