Download b. Study Implementation

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:
[email protected]. Incomplete applications will not be evaluated.
A. 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, HIPAA & GCP) 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 (Citi Program) 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 ([email protected]) (787-759-0306 ext. 232).
The evaluation process for this application can take between 10 to 20 working
days.
Revised: August 2016 /2
B. 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
Drug administration
Procedure assistance
Vital signs
Phlebotomy
Transportation Service (UPR-MSC only)
Examination Room
Interview/Questionnaire Room
Record Room
Medication Storage
Medication Facilities (Preparation/Administration)
Dental Services
Other, specify:
Technologies and Resources for Core Laboratories (TRCL)
Bioanalytical Core Lab (Located at the University of Puerto Rico- Medical Sciences Campus)
Centrifuge samples
Prepare slides
Storage (room temperature, refrigerated, frozen)
Packing & Shipping (room temperature, dry ice)
Preservation of samples (with diluents, buffers, etc.)
Serum samples for Comprehensive Metabolic Panel
(Glucose, BUN, Creatinine, electrolytes, etc.), Basic Metabolic
Panel, and Lipid Panel
Whole blood samples for glycohemoglobin
Urine sample for Micro albumin
CBC (Complete Blood Count) and 5-part differential
Urine sample for Urinalysis
Pregnancy Tests
Isolation of PBMC from whole blood
Lab equipment
Freezer (-20°C)
Freezer (-80°C)
Refrigerated Centrifuge
Hood
Microscope
Other, specify:
HIV and substance of abuse laboratory core (Located at the Universidad Central del Caribe)
COBAS AmpliPrep/TaqMan
HIV Viral load (Quantitative PCR)
HCV Viral load (Quantitative PCR)
COBAS Amplicor
HCV PCR (Qualitative)
OpenGene System
HIV-1 drug resistance genotyping
HCV genotyping
Infinite Microplate Reader
HIV p24 measurement (ELISA)
Cytokine/Chemokine measurement (ELISA)
Cell-Mediated Cytotoxicity assays
NF-kB expression assay
ELISPOT Reader
In vivo/in vitro cytotoxicity measurements
QuanSys Reader
Apoptosis antibody array
DNA/Protein Microarray Reader
Protein and gene expression
FACSCanto II Flow Cytometer
Immunophenotyping (CD4/CD8)
Intracellular cytokines/chemokines
Cytokine/Chemokine Bead Array
Apoptosis assay
T and B cell activation, proliferation,
differentiation
assays (CD3/CD8/CD4/CD45)
Cell viability, cell proliferation, cytotoxicity
measurement
Other
Cell Culture
PCR
CBA
p24 TRL4
Elisa Array
Intracellular Proteins
Western Blot
Other, specify:
Other, specify:
Revised: August 2016 /3
Molecular Biology Core Laboratory (Located at Ponce Health Sciences University)
Tissue Culture
Transfection/Transformation
DNA, RNA and Protein Isolation
Cell Cryostorage
Expertise/consultation in experimental design using
molecular biology
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
Excel
Access
EPI-Info
Administrative Core (AC)
Funding Support
Other administrative support, specify:
C. Investigator(s) Information
Principal Investigator
1. First Name:
2.
3.
4.
5.
6.
7.
8.
Last Name:
Degree:
Current Position:
Institution:
School:
Department:
Program:
Email:
Phone (XXX-XXX-XXXX):
Select degree
Select position
Select academic affiliation
Select school
Select department
Co PI or Co Investigators
Select
9. First Name:
Last Name:
Degree:
Current Position:
Institution:
School:
Department:
Program:
Email:
Phone (XXX-XXX-XXXX):
Select degree
Select position
Select academic affiliation
Select school
Select department
STATA
SPSS
Other, specify:
Revised: August 2016 /4
Select
First Name:
Last Name:
Degree:
Current Position:
Institution:
School:
Department:
Program:
Email:
Phone (XXX-XXX-XXXX):
Select degree
Select position
Select academic affiliation
Select school
Select department
D. Study Staff
Please include information of study 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):
E. Study Information
Please complete the following information.
1. Full title of the Study:
2. Short Title of the Study:
(do not exceed 80 characters)
3. Research Areas:
Cardiovascular
Cancer
Other, specify:
HIV
Neuroscience
4. IRB/IACUC Number:
5. IRB/IACUC Expiration Date:
(mm/dd/yyyy)
6. Institutional Biosafety Committee
(IBC) Expiration Date (mm/dd/yyyy)
(if applicable):
7. Is this a competitive study?
8. National Clinical Trial (NCT)
number:
(Another term for ClinicalTrials.gov
registry) (if applicable)
9. Support requested until:
Yes, specify the recruiting deadline (mm/yyyy):
No
(mm/dd/yyyy)
10. Multicenter Study:
Yes
No
11. Clinical Trial Phase (if applicable):
(I, II, III or IV)
12. Please provide a study abstract (< 250 words)
 Background:
Revised: August 2016 /5
 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.
F. 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
Sex / Gender
Please enter quantities
Female
Male
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category total of subjects*
Racial Categories
Female
Male
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.
Totals
Totals
G. 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
MULTI-PI/
(Last Name, First Name)
Institution / Affiliation
Co-PI
Select
1.
Select
Select
2.
Select
Select
3.
Select
Select
4.
Select
Select
5.
Select
Revised: August 2016 /6
Mentors
(Last Name, First Name)
1.
2.
3.
Consultants
(Last Name, First Name)
1.
2.
3.
Institution / Affiliation
Select
Select
Select
Institution / Affiliation
Select
Select
Select
Will you share any of the following resources with other(s) investigator(s) during this study? (Select all that apply)
1. Biomedical Sample Sharing:
2. Research Subjects/Volunteers Sharing:
3. Data/Recorded Information Sharing:
4. Staff Sharing (e.g., coordinators, nursing staff,
research assistants, or technicians):
No
Yes, please provide investigator(s) name (Last Name,
First Name)
No
Yes, please provide investigator(s) name (Last Name,
First Name)
No
Yes, please provide investigator(s) name (Last Name,
First Name)
No
Yes, please provide investigator(s) name (Last Name,
First Name)
H. Study Funding Support
Federal
Please provide information regarding the research protocol funding support:
Institution/Agency
Sponsor
Grant #
Name
NIH
Non- Federal
Other
**Specify grant Principal Investigator (PI)
Industry
Foundation/ Research
Institute Funds
Professional and Voluntary
Association or Society Funds
State, Country, City funds
None
Other Grants
Investigator Initiated
Please access the following link to verify the
grant number and PI information
http://projectreporter.nih.gov/reporter.cfm
Total Budget
(For funding period)
Revised: August 2016 /7
I. Investigator’s Responsibilities:
Progress Report: We will request an annual progress report for each study. This
information is part of NIH requirements to continue funding the PRCTRC.
Data Sharing: Data sharing is essential for expedited translation of research results into
knowledge, product and procedures to improve human health. The National Insitutes of
Health (NIH) has a policy to share and make available to the public the results and
accomplishments of the activities that it funds.
Compliance: Please be awarded that the PRCTRC is encouraging that all research
activities are in compliance with the federal policies, rules and guidelines for research
involving animals or subjects. For this reason, your study supported by the PRCTRC
needs to follow the PRCTRC Standard Operational Procedures and could be audited by
the Regulatory Knowledge and Support (RKS) Core.
Acknowledgement of support: Each publication, press release or other document that
results from NIH grant supported research must include an acknowledgment of NIH
grant support and disclaimer such as: The research project described was supported by
Award Number U54MD007587 from the National Institute of Health and Health
Disparities. The content is solely the responsibility of the authors and does not
necessarily represent the official views of the National Institute of Health and Health
Disparities or the NIH.
The PRCTRC is committed in providing each study the best possible service. Due to a
reduction in federal funding we may bill services for cost recovery. These funds will be
used to continue supporting research projects.
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):
REMEMBER:
During the months of July and December, the UPR-MSC has an academic and administrative recess.
Therefore, all protocols approvals can be delayed until August and January, respectively.