Revised: August 2016 /1

Study Implementation

Application Form

New Study
Active PRCTRC supported study requesting another PRCTRC service
(Select only the new service. For more information please Contact the RKS Staff)
Reactivate an Study
(Select this option if your study has not received any PRCTRC support in the last three years at the time of your approval notification)

To request our services, please send the completed Application Form with the required documents to: . Incomplete applications will not be evaluated.

  1. Required Documents

In order to approve your request, we will need the following documents to be submitted as pdf electronic files. These documents will be sent to the NIH in order to report our outcomes and justify our budget. (To open the links hold down “Ctrl” button).

Biographical Sketch(PI, CO & Sub-Investigators)

Training Certifications (Human Subject Protection, HIPAAGCP) for each person included in the personnel log & IACUC training certifications (if applicable)

Copy of Biosafety approval letter (if applicable)

Copy of IACUC approval letter (if applicable)

Copy of Informed Consents, approved and stamped by the IRB

Copy of IRB approval letter

Copy of the IRB approval letter for advertisement (Only applies to those studies that will use the PRCTRC telephone as contact number).

Copy of the Notice of Award letter or copy of signed contract between the corresponding institution and the sponsor (if applicable)

Data Safety Monitoring Plan / Data Safety Monitoring Board (if applicable)

Personnel Log

PRCTRC Confidentiality Agreement

Research Protocol

Requirements for study personnel that will perform any task in the PRCTRC laboratory: evidence of Hepatitis B vaccine, Bio-safety training (CitiProgram) and the“Manejo de Desperdicios Biomédicos Regulados” (DBR) training given by the institution.

If you have any questions, please contact the Regulatory Knowledge and Support Coordinator

Ms. Madeline Maldonado () (787-759-0306 ext. 232).

The evaluation process for this application can take between 10 to 20 working days.

  1. PRCTRC Core(s) Request

Please select the services or support you request for your study. Select all that apply.
Clinical Research Resources and Facilities (CRF)
Nursing Services / Interview/Questionnaire Room
Drug administration / Record Room
Procedure assistance / Medication Storage
Vital signs / Medication Facilities (Preparation/Administration)
Phlebotomy / Dental Services
Transportation Service (UPR-MSC only) / Other, specify:
Examination Room
Technologies and Resources for Core Laboratories (TRCL)
Bioanalytical Core Lab (Located at the University of Puerto Rico- Medical Sciences Campus)
Centrifuge samples / CBC (Complete Blood Count) and 5-part differential
Prepare slides / Urine sample for Urinalysis
Storage (room temperature, refrigerated, frozen) / Pregnancy Tests
Packing & Shipping (room temperature, dry ice) / Isolation of PBMC from whole blood
Preservation of samples (with diluents, buffers, etc.) / Lab equipment
Serum samples for Comprehensive Metabolic Panel (Glucose, BUN, Creatinine, electrolytes, etc.), Basic Metabolic Panel, and Lipid Panel / Freezer (-20°C)
Freezer (-80°C)
Refrigerated Centrifuge
Whole blood samples for glycohemoglobin / Hood
Urine sample for Micro albumin / Microscope
Other, specify:
HIV and substance of abuse laboratory core (Located at the Universidad Central del Caribe)
COBAS AmpliPrep/TaqMan / FACSCanto II Flow Cytometer
HIV Viral load (Quantitative PCR) / Immunophenotyping (CD4/CD8)
HCV Viral load (Quantitative PCR) / Intracellular cytokines/chemokines
COBAS Amplicor / Cytokine/Chemokine Bead Array
HCV PCR (Qualitative) / Apoptosis assay
OpenGene System / T and B cell activation, proliferation, differentiation assays (CD3/CD8/CD4/CD45)
HIV-1 drug resistance genotyping / Cell viability, cell proliferation, cytotoxicity measurement
HCV genotyping / Other
Infinite Microplate Reader / Cell Culture
HIV p24 measurement (ELISA) / PCR
Cytokine/Chemokine measurement (ELISA) / CBA
Cell-Mediated Cytotoxicity assays / p24 TRL4
NF-kB expression assay / Elisa Array
ELISPOT Reader / Intracellular Proteins
In vivo/in vitro cytotoxicity measurements / Western Blot
QuanSys Reader / Other, specify:
Apoptosis antibody array / Other, specify:
DNA/Protein Microarray Reader
Protein and gene expression
Molecular Biology Core Laboratory (Located at Ponce Health Sciences University)
Tissue Culture / Cell Cryostorage
Transfection/Transformation / Expertise/consultation in experimental design using molecular biology
DNA, RNA and Protein Isolation / Other, specify:
Biomedical Informatics Core (BIC)
Computer equipment with internet and intranet connections for literature search (Computer Cluster Facility)
Set up an account to access REDCap (REDCap test server)
Storage of electronic data in PRCTRC REDCap production server
Other, specify:
Research Design and Biostatistics Core (RDB)
Data Entry (PRCTRC Pilot Projects ONLY) / Database design and validation
REDCap / STATA
Excel / SPSS
Access / Other, specify:
EPI-Info
Administrative Core (AC)
Funding Support
Other administrative support, specify:
  1. Investigator(s) Information

  1. First Name:

  1. Last Name:

  1. Degree:
/ Select degreePhDMDMD/PhDPsyDEdDDVMDMDMSMPHOther, specify:
  1. Current Position:
/ Select positionAssistant ProfessorAssociate ProfessorAdjunt ProfessorVisiting ProfessorProfessorInstructorInvestigators/ResearcherOther, specify:
  1. Institution:
/ Select academic affiliationUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
  1. School:
/ Select schoolSchool of Dental MedicineSchool of Health ProfessionalsSchool of MedicineSchool of PharmacySchool of Public HealthOther, specify:
  1. Department:
/ Select departmentBasic Sciences DepartmentClinical Sciences DepartmentEcological Sciences DepartmentEnvironmental HealthEpidemiology and BiostatisticsGraduate DepartmentHealth Services AdministrationHuman DevelopmentPost-doctoral ProgramRestorative Sciences DepartmentSocial SciencesSub Graduate DepartmentSurgical Sciences DepartmentOther, specify:
  1. Program:

Email:
Phone (XXX-XXX-XXXX):

Co PI or Co Investigators

  1. First Name:

Last Name:
Degree: / Select degreePhDMDMD/PhDPsyDEdDDVMDMDMSMPHOther, specify:
Current Position: / Select positionAssistant ProfessorAssociate ProfessorAdjunt ProfessorVisiting ProfessorProfessorInstructorInvestigators/ResearcherOther, specify:
Institution: / Select academic affiliationUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
School: / Select schoolSchool of Dental MedicineSchool of Health ProfessionalsSchool of MedicineSchool of PharmacySchool of Public HealthOther, specify:
Department: / Select departmentBasic Sciences DepartmentClinical Sciences DepartmentEcological Sciences DepartmentEnvironmental HealthEpidemiology and BiostatisticsGraduate DepartmentHealth Services AdministrationHuman DevelopmentPost-doctoral ProgramRestorative Sciences DepartmentSocial SciencesSub Graduate DepartmentSurgical Sciences DepartmentOther, specify:
Program:
Email:
Phone (XXX-XXX-XXXX):

First Name:
Last Name:
Degree: / Select degreePhDMDMD/PhDPsyDEdDDVMDMDMSMPHOther, specify:
Current Position: / Select positionAssistant ProfessorAssociate ProfessorAdjunt ProfessorVisiting ProfessorProfessorInstructorInvestigators/ResearcherOther, specify:
Institution: / Select academic affiliationUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
School: / Select schoolSchool of Dental MedicineSchool of Health ProfessionalsSchool of MedicineSchool of PharmacySchool of Public HealthOther, specify:
Department: / Select departmentBasic Sciences DepartmentClinical Sciences DepartmentEcological Sciences DepartmentEnvironmental HealthEpidemiology and BiostatisticsGraduate DepartmentHealth Services AdministrationHuman DevelopmentPost-doctoral ProgramRestorative Sciences DepartmentSocial SciencesSub Graduate DepartmentSurgical Sciences DepartmentOther, specify:
Program:
Email:
Phone (XXX-XXX-XXXX):
  1. Study Staff

Please include information ofstudy coordinator or contact person: (Only if you request services from Clinical Research Resources and Facilities (CRF) and/or Technologies Resources and Core Laboratories (TRCL) in the UPR-MSC)

Name (Last Name, First Name):
Email:
Phone (XXX-XXX-XXXX):
  1. Study Information

Please complete the following information.

  1. Full title of the Study:

  1. Short Title of the Study:
(do not exceed 80 characters)
  1. Research Areas:
/ Cardiovascular / HIV
Cancer / Neuroscience
Other, specify:
  1. IRB/IACUC Number:

  1. IRB/IACUC Expiration Date:
(mm/dd/yyyy)
  1. Institutional Biosafety Committee (IBC) Expiration Date(mm/dd/yyyy)(if applicable):

  1. Is this a competitive study?
/ Yes, specify the recruiting deadline (mm/yyyy):
No
  1. National Clinical Trial (NCT) number:
(Another term for ClinicalTrials.gov registry) (if applicable)
  1. Support requested until:
/ (mm/dd/yyyy)
  1. Multicenter Study:
/ Yes No
  1. Clinical Trial Phase(if applicable):
/ (I, II, III or IV)
  1. Please provide a study abstract (< 250 words)

  • Background:

  • Aims/Objectives:

  • Materials and Methods to be used:

  • Findings, Results or Conclusions (if applicable):

13. Provide a brief explanation of how this research project addresses health disparities.
  1. Enrollment Information

Expected Date Enrollment Begins (mm/dd/yyyy):
Expected Date Enrollment Ends (mm/dd/yyyy):
Total Number of Human Subject Expected for the entire study at your site:
Targeted/Planned Enrollment Table: Number of Subjects
Ethnic Category
Please enter quantities / Sex / Gender
Female / Male / Totals
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category total of subjects*
Racial Categories / Female / Male / Totals
American Indian / Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Racial Categories: Total of all subjects*

*Totals must be equal to number of subjects expected.

  1. Study Collaborations

This section is to assess the research collaborations in this study. These collaborations include relations/interactions among collaborators (e.g., Co-Investigators, Multiples PI, Co-PI), mentors, consultants, and institutions (e.g., UPR-MSC, PHSU, UCC, others).

In order to document collaborations among PRCTRC investigators, please list all the collaborations related to this study. Do not include collaborations with coordinators, nursing staff, research assistants, or technicians.
Collaborators
(Last Name, First Name) / MULTI-PI/
Co-PI / Institution / Affiliation
1. / SelectMultiple-PICo-PI / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
2. / SelectMultiple-PICo-PI / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
3. / SelectMultiple-PICo-PI / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
4. / SelectMultiple-PICo-PI / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
5. / SelectMultiple-PICo-PI / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
Mentors
(Last Name, First Name) / Institution / Affiliation
1. / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
2. / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
3. / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
Consultants
(Last Name, First Name) / Institution / Affiliation
1. / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
2. / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
3. / SelectUPR Medical Sciences CampusPonce Health Sciences UniversityUniversidad Central del CaribeUPR Comprehensive Cancer CenterUPR Rio Piedras Other, specify:
Will you share any of the following resources with other(s) investigator(s) during this study? (Select all that apply)
  1. Biomedical Sample Sharing:
/ No
Yes, please provide investigator(s) name (Last Name, First Name)
  1. Research Subjects/Volunteers Sharing:
/ No
Yes, please provide investigator(s) name (Last Name, First Name)
  1. Data/Recorded Information Sharing:
/ No
Yes, please provide investigator(s) name (Last Name, First Name)
  1. Staff Sharing (e.g., coordinators, nursing staff, research assistants, or technicians):
/ No
Yes, please provide investigator(s) name (Last Name, First Name)
  1. Study Funding Support

Please provide information regarding the research protocol funding support:

Federal / Sponsor / Institution/Agency Name / Grant # / Total Budget
(For funding period)
NIH / Please access the following link to verify the grant number and PI information

Other
**Specify grant Principal Investigator (PI)
Non- Federal / Industry
Foundation/ Research Institute Funds
Professional and Voluntary Association or Society Funds
State, Country, City funds
Other Grants
None / Investigator Initiated
  1. Investigator’s Responsibilities:

I,, agree to fulfill the Investigator’s responsibilities and submit the information requested by Puerto Rico Clinical and Translational Research Consortium (PRCTRC).

Please provide an electronic signature.

Date submitted(mm/dd/yyyy):