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ALL NEW AND ONGOING RESEARCH PROJECT UPDATES MUST BE SUBMITTED TO RESEARCH@Submission Checklist Please provide the following documents with your study submission. For studies submitted via USF BullsIRB only provide documents not available on the portal. ? Protocol ? Informed Consent (s) ? No Consent Requirement ? Applying for ICF Waiver to IRB ? Research instruments (e.g. Questionnaires, data collection sheets, ect.) ? Letters of support from external entities? Grant (s)? Contract(s) ? IND/IDE number (experimental uses of drugs or devices) ? Investigators Brochure/IFU (for experimental uses of drugs or devices) ? Investigator Curriculum Vitae’s for Primary Investigator and Associated InvestigatorsStudies requiring unit support will go through feasibility process at Tampa General Hospital prior to any study activity on unit. Please complete the following forms as applicable. For a complete list visit: TGH Support Request Documents ? TGH Unit Operational Review of Proposes Research (e.g. Unit(s) impacted, activities) ? TGH Imaging Operational Review of Proposed Research (Diagnostic testing, MRI, CT, etc.) ? Technology Operational Review of Proposed Research (Data image transfer/ upload requests)? TGH Drug Research Information Sheet (Investigational Drug Studies) ? TGH Device Research Information Sheet (Investigational Device Studies) For IRB Submission Document visit Bulls IRB Library page:HYPERLINK "C:\\Users\\D42400\\AppData\\Local\\Microsoft\\Windows\\INetCache\\Content.Outlook\\FU2Z8DJ0\\USF Bulls IRB". GENERAL STUDY INFORMATIONFull Study Title:Short Title: (descriptive title to be used for study ID in EPIC/EMR and CTMSStudy Protocol Number:IRB Name: FORMCHECKBOX USF IRB FORMCHECKBOX WIRB FORMCHECKBOX Other, specify:IRB #: FORMCHECKBOX Pending availableNCT #: FORMCHECKBOX NA FORMCHECKBOX Pending availablePrincipal Investigator (PI) Name:PI Affiliation and Department:Primary Coordinator Name:Study Phase FORMCHECKBOX Pilot FORMCHECKBOX Phase I FORMCHECKBOX Phase II FORMCHECKBOX Phase III FORMCHECKBOX Phase IV FORMCHECKBOX NAIf the study is phase IV or post marketing, is the study required by the FDA? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX NAAre the products FDA approved for use in the indication under study? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX NADoes the study involve stem cells or gene therapy/transfer? FORMCHECKBOX Yes FORMCHECKBOX No If yes, provide a description:Number of Planned Subjects:Funding Source(s);select ALL that apply FORMCHECKBOX TGH directly holds contract with sponsoring agency FORMCHECKBOX Industry-Sponsored FORMCHECKBOX Government Sponsored (e.g. NIH, DOD) FORMCHECKBOX Investigator FORMCHECKBOX Other funding, specify (e.g. industry funding; department funding; government or non-government grant support):_________________________ FORMCHECKBOX N/ALevel of TGH staff involvement; select ALL that apply FORMCHECKBOX Perform invasive or non-invasive procedures for research purposes outside the scope of standard of care FORMCHECKBOX Manipulate the environment for research purposes FORMCHECKBOX Interact for research purposes FORMCHECKBOX Obtain informed consent FORMCHECKBOX Obtain identifiable private information or identifiable biological specimens from any source for the research FORMCHECKBOX Recruitment of research subjects B. RESEARCH ACTIVITIES AT TGHWhat research activities will occur at TGH? (select ALL that apply) FORMCHECKBOX Recruitment FORMCHECKBOX Labs FORMCHECKBOX Drug administration FORMCHECKBOX Surgery FORMCHECKBOX Other____________ FORMCHECKBOX Enrollment (consent) FORMCHECKBOX Diagnostics FORMCHECKBOX Follow-up FORMCHECKBOX Device Implant FORMCHECKBOX Treatment FORMCHECKBOX Drug dispensing FORMCHECKBOX Data collection FORMCHECKBOX Physical ExamsLocation(s) where research activities and education will occur: (select ALL that apply) FORMCHECKBOX Specialty Surgery Unit FORMCHECKBOX ACE Unit (Acute Care for elderly) FORMCHECKBOX Complex Medicine FORMCHECKBOX Oncology 1 7C1 FORMCHECKBOX Oncology 2 7C2 FORMCHECKBOX Gynecology Unit FORMCHECKBOX Surgery Trauma 8C2 FORMCHECKBOX Primary Care 8A1 & 2 FORMCHECKBOX Neuroscience 1 9A1 FORMCHECKBOX Neuroscience 2 9A2 FORMCHECKBOX Psychiatric FORMCHECKBOX Burn Center FORMCHECKBOX Orthopedic Trauma FORMCHECKBOX Joint Replacement Center FORMCHECKBOX Short Stay Center FORMCHECKBOX GE Center FORMCHECKBOX Operating Rooms 3F FORMCHECKBOX Post Anesthesia Care FORMCHECKBOX Main OR FORMCHECKBOX Cardiac OR FORMCHECKBOX Nursing 4R FORMCHECKBOX Cardiac Cath Lab FORMCHECKBOX Angio/Interventional FORMCHECKBOX Parathyroid Center FORMCHECKBOX Vascular Surgical Acute Care FORMCHECKBOX Complex Medicine FORMCHECKBOX Nursing 3R FORMCHECKBOX Clinical Education FORMCHECKBOX Observation Unit FORMCHECKBOX Endoscopy Center FORMCHECKBOX Mother Baby Unit FORMCHECKBOX Pathology FORMCHECKBOX Infusion/Cancer Center FORMCHECKBOX ER FORMCHECKBOX ICU—Surgical Trauma FORMCHECKBOX ICU—Neurosciences 1 FORMCHECKBOX ICU—Neurosciences 2 FORMCHECKBOX ICU—Medical 2D1-2 FORMCHECKBOX ICU—Medical ICU 2 FORMCHECKBOX Adult Medical Surgical ICU FORMCHECKBOX ICU - Vascular FORMCHECKBOX CTICU FORMCHECKBOX CCU FORMCHECKBOX Cardiac Transition FORMCHECKBOX Cardiac Telemetry Unit 5A1-2 FORMCHECKBOX Cardiovascular Telemetry 3H1 FORMCHECKBOX 3K/CV Center FORMCHECKBOX ICU - Adult Stepdown 5A FORMCHECKBOX Cardiac Care FORMCHECKBOX Transplant - Administration FORMCHECKBOX Transplant 1 (7F & 8F) FORMCHECKBOX Transplant 2 9F1 FORMCHECKBOX Pediatric Medical/Surgical FORMCHECKBOX PICU FORMCHECKBOX NICU South FORMCHECKBOX NICU North FORMCHECKBOX Labor & Delivery FORMCHECKBOX Antepartum/Postpartum FORMCHECKBOX Pediatric Dialysis FORMCHECKBOX Rehabilitation FORMCHECKBOX Adult Dialysis – Apheresis Unit FORMCHECKBOX ObservationClinics: FORMCHECKBOX 30th Street—Pediatrics FORMCHECKBOX 30th Street—Genesis FORMCHECKBOX Transplant Thoracic FORMCHECKBOX Physician Services – Specialty Clinic FORMCHECKBOX Kennedy—Family Practice FORMCHECKBOX Outpatient Rehabilitation FORMCHECKBOX Harbourside Medical Tower (HMT) FORMCHECKBOX 409 Bayshore Transplant Clinic – 4th floor FORMCHECKBOX CORE: 5th floor 409 Bayshore Suites: FORMCHECKBOX Surgical Suites FORMCHECKBOX CV Pre and Post Procedure FORMCHECKBOX Outpatient Surgery FORMCHECKBOX Pre-op Center FORMCHECKBOX PACU FORMCHECKBOX Bariatric Center FORMCHECKBOX Outpatient Diagnostics FORMCHECKBOX Outpatient Laboratory FORMCHECKBOX Pediatric Day Hospital FORMCHECKBOX Brandon Healthplex ED FORMCHECKBOX Other, specify:______________ C. STUDY SUPPORT INFORMATIONWhat TGH support will be needed? (select ALL that apply) Note: If applicable, a fee schedule will be provided if services are requested. Laboratory: FORMCHECKBOX N/A FORMCHECKBOX Sample CollectionIf yes, specify: FORMCHECKBOX Identifiable FORMCHECKBOX Non-Identifiable FORMCHECKBOX Process FORMCHECKBOX Store FORMCHECKBOX Ship FORMCHECKBOX Tumor specimen sample prepRegulatory: FORMCHECKBOX N/A FORMCHECKBOX Regulatory SupportPharmacy: FORMCHECKBOX N/A FORMCHECKBOX Storage FORMCHECKBOX Randomization FORMCHECKBOX Dispensing Study Coordinator: FORMCHECKBOX N/A FORMCHECKBOX Study Coordinator Support Nurse Coordinator: FORMCHECKBOX N/A FORMCHECKBOX Study Coordinator Support IT: FORMCHECKBOX N/A FORMCHECKBOX Reports FORMCHECKBOX Data FORMCHECKBOX BPA FORMCHECKBOX Order Set FORMCHECKBOX Other, specify: Does the study involve data transfers (e.g. CT Scan/MRI)? FORMCHECKBOX No FORMCHECKBOX Yes If yes, provide details:Does the study involve the addition of software and/or hardware? FORMCHECKBOX No FORMCHECKBOX Yes If yes, provide details:Who will purchase the investigational drug/device/agent? FORMCHECKBOX N/A FORMCHECKBOX Physician/Practice Group FORMCHECKBOX Tampa General Hospital (advanced purchase) FORMCHECKBOX Tampa General Hospital (consigned/leased from sponsor) FORMCHECKBOX Sponsor will provide free of charge FORMCHECKBOX Other, specify: _________________ Where will the drug/device/agent be stored? FORMCHECKBOX N/A FORMCHECKBOX Physician/Practice Group FORMCHECKBOX Tampa General Hospital Investigational Pharmacy FORMCHECKBOX Sponsor will provide on a case-by-case basis FORMCHECKBOX Other, specify: _________________ Other research support: FORMCHECKBOX N/ASpecify:List ALL services to be performed at TGH (complete the table below)Visit #/NameLocation where procedure, test, item, or service to be performedDescription of procedure, test, item or other service:(ex. informed consent, EKG, imaging, specimen collection and/or processing. Include CPT/HCPCS code(s), if applicable)Performed by TGH, TGH CORE Staff, or PI/External (non-TGH) Staff?Submitter Signature: ______________________________ Date of Signature: _________________Thank you for your interest in performing/conducting your research project/study at Tampa General Hospital (TGH). ................
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