Participants and Clinical Interaction Resources (PCIR)
Administration / Clinical Services Coordinator
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 Antonia L. Ortiz, BS, MT, CHS, who has been involved in the UPR-MSC Neuro-AIDS Program during the last ten years and has coordinated collaborative efforts in that program with UCC and PSM, and other outside institutions. Ms. Ortiz will coordinate among other activities the PCIR efforts to accomplish the 4th specific aim to implement mechanisms to foster the interaction and collaboration of basic, clinical and epidemiological resources.
Antonia L. Ortiz, BS,MT,CHS
Program Coordinator for Collaborations and Partnerships &
Participant and Clinical Interaction Resources
787-759-0306 ext. 232
The Puerto Rico Clinical and Translational Research Consortium (PRCTRC) Participants Clinical Interaction Resources (PCIR) nursing staff is composed of a nurse supervisor, Laritza Berríos, BSN, RN, CON and two research nurses, Bárbara Guzmán, BSN, RN, MPH and María del Pilar Cotto, BSN. The nursing staff is highly qualified to perform the procedures required by each protocol. The working hours for clinical procedures begin at 7:00 a.m.until 5:00p.m. 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.
For more information about nursing services please contact:
Laritza Berrios, BSN, RN, CON at:
Phone: (787) 759-0306 ext. 236
Fax: (787) 756-6499
Dr. Elsa M Pedro is the pharmacist in charge. She will provide assistance in protocol development, drug procurement, preparation of codes for blinding studies, and compounding of special dosage forms. In addition she will provide:
- Provide consultation to physicians, nurses and other health professionals concerning usage, interactions and contraindications regarding drugs involved in investigational protocols.
- Prepare and make available, and distribute to investigators summaries of basis information regarding IND’ s approved for use, prior to dispensing any investigational drug. This responsibility is shared with the principal investigator.
For more information about nursing services please contact:
Elsa M Pedro, Pharm.D.
The center provides a part-time Dental Hygienist who is responsible for
- daily preparation of the dental examination room
- assistance in the dental procedures
- Provide educational intervention
- Sterilization of dental equipment
Madeline Maldonado, M.P.H., B.H.E., Certified in Gerontology, is the Patient Coordinator of the PRCTRC. She provides regular units coverage from 7:30am - 4:00pm, Monday through Friday. She is responsible for scheduling the subjects for the research-related appointments; her goal is to facilitate the participation of the subjects in the clinical studies in collaboration with the research staff and the investigators. The patient coordinator works closely with the nursing staff in order to assure patient contact and adequate follow-up.
For more information about patient coordination services, please contact:
Madeline Maldonado, MPH, BHE at:
Phone: (787) 759-0306 ext. 221
Fax: (787) 759-0305
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, assistance in the performance of biopsy procedures, physical examination, lumbar puncture procedure, pelvic exam, etc., 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 off sites visits are scheduled weekly and for these visits official transportation is provided.
The nursing facilities and equipment provide by the PRCTRC at the UPR MSC includes:
- Seven examination/study rooms. Two of them are equipped for gynaecologic 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/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.
- LifePak 500 Automated External Defibrillator.
- Pediatric and Adult Emergency Carts.
- Storage medication area with access code, lock cabinets and refrigerator.
- Room temperature and refrigerator thermometers.
- 24 hr time Recorder for refrigerator temperature.
- Megathoscope in each examination room.
- Record room facility with access code.
- Storage facilities for laboratory kits.
- Locked medicine cabinet with an additional refrigerator.
- Fax machine for private medical information.
* All the equipment is calibrated and certified by an authorized company. These documents are available upon requested.
Transportation services provided for off-sites visits, pick-up and delivery of clinical research specimen samples
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 ft 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 11 municipalities that include: Bayamon, Toa Alta, Corozal, Vega Alta, Toa Baja, Naranjito, Orocovis, Catafio, Barranqultas and Dorado. Its estimated population is 620,000 inhabitants according to the year 2006 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.
Ponce School of Medicine & Health Sciences (PSM&HS)
PSM&HS is affiliated with several hospitals and healthcare facilities. The institution also owns an Outpatient Clinic located in its main campus and administers mental health facilities in Mayaguez, Aguadilla and Ponce. The affiliation network provides over 2,000 beds and several ambulatory facilities available for clinical teaching, training and research. The affiliated institutions include the following, among others:
- Andrés Grillasca Oncology Hospital-Ponce
- Bella Vista Hospital-Yauco
- Cristo Redentor Hospital-Guayama
- Damas Hospital-Ponce
- Dr Pila Family Center and Hospital-Ponce
- Emeterio Betances University Hospital-Mayaguez
- First Hospital Panamericano-Ponce
- La Concepción Hospital-San Germán
- Ponce Playa Diagnostic and Treatment Center-Ponce
- San Antonio Hospital-Mayaguez
- San Cristobal Hospital-Ponce
- Saint Luke’s Episcopal Hospital-Ponce
- Phlebotomy in Research Subjects
- Access of External Research Staff to the PRCTRC
- Storage of Investigational Drugs
- File of Inactive Research Studies Documents
- Informed Consent Process
- Non-serious Adverse Events
- Serious Adverse Events
- Receipt and Sending of Documents via Facsimile
- Removal of Research Source Documents
- Telephone Use
- Deviation in Temperature of Study Medications Storage Areas
- Consent for Medical Services
- Phlebotomy in Control Subjects for Research
- Off Site Visits (Community Visits)
- Intervention from External Research Personnel to Perform Procedures
- Disposal of Study Medications