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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.