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Baptist Health Administrative Research Approval Committee (ARAC) APPLICATION FOR REVIEW NOTE: Studies must receive ARAC approval before presentation to the Institutional Review Committee (IRC). Protocol Title : Sponsor Name: Study #: Address: Phone: INVESTIGATIVE TEAM PERSONNEL Principal Investigator: Degree: Title: Fax : Phone: Pager: Cell Phone: If not Baptist Health employee: Email: Employer: Privileges: Address: Please list all Investigators and Research Assistants who will be participating in this study: Degree: Lead Study Coordinator: Title: Fax : Phone: Pager: Cell Phone: Email: Address: Please list all investigators who will be participating in this study: Page 1 of 6 If not Baptist Health employee: Employer: Privileges: RESEARCH CATEGORY Please check appropriate classification A. Research participants enrolled in a non-sponsored or investigator-initiated study. B. Research participants receiving established medical care (standard of care). Costs paid by third party. C. Research participants enrolled on an industry-sponsored protocol. All costs for non-standard of care items must be paid by the industry sponsor. D. Request for hospital assistance in costs for non-standard of care charges. * If you check box “C”, please contact a Finance Administrator to discuss the budget. If you check box “D”, please contact the Hospital President(s) at the sites where you are planning to perform the research. SITE(S) REQUESTED Please indicate your preferred site(s) for this work; use numbers to prioritize your preference (if applicable): Baptist-Downtown Wolfson Children’s Hospital Adult Units Heart Hospital Emergency Department Med/Surg ICU Radiology/Nuclear Medicine Cath Lab/EKG/Respiratory Operating Room Pharmacy Laboratory Oncology (BCI, FROG) Other: Baptist-South Baptist Nassau Baptist-Beaches Other: Pediatric Units Emergency Department Med/Surg Oncology NICU PICU CRC Operating Room Pharmacy Laboratory Other: PROTOCOL ABSTRACT Abstract : The abstract should include a description of the aims of the project, importance, and methods/interventions of the study. Should be written in laymen’s terms (8th grade reading level). Include explanation of involvement of any hospital departments. Page 2 of 6 PROJECTION UTILIZATION Projected Enrollment: Specify Participant Diagnosis(es) and/or Inclusion Criteria: Specialty Rooms Required For the Study Negative pressure isolation Monitored sleep room Lead-lined room Start Date: End Date: Special Storage Other: Applicant Comments: PARTICIPANT AGE RANGE check all that apply Birth - 1 month >10 - 17 years >1 month - 2 years >18 - 64 years >2 - 10 years >65 Applicant Comments: EQUIPMENT REQUIRED FOR STUDY Indicate all equipment needed for the study (e.g. infusion pumps, hand-warming box, glucose analyzers, cardiac monitor, blood pressure machines, etc.) List investigator/sponsor-owned equipment being used for this study and whom the equipment will be provided by and where will it be stored. Note: All equipment that is not the property of Baptist Health must be cleared by Biomed prior to being utilized for research. Page 3 of 6 NURSING AND RESPIRATORY SERVICES Depending on the complexity of your study, and the degree of nursing involvement, a Nursing fee may be assessed. Please check all procedures that are required for this protocol. Please indicate if standard of care or non-standard of care. If monitoring is required, please list the frequency. InPt OutPt Procedures Requested IV Lines: # ____ Central line blood draws, # ____ Blood draws per participant ___ Medication administration Questionnaires – #_____: Other specimen collection (stool, urine, etc.) ____________ Number per subject: ______ ____________ Number per subject: ______ ____________ Number per subject: ______ Administer blood, blood products Pre- / Post-operative care Enteral tube placement Continuous/intermittent IV drug infusion: Length of infusion:______ Seizure/sleep monitoring Pulse oximetry monitoring InPt OutPt Procedures Requested Urinary catheterization Central line care Aerosolized treatments Blood glucose monitoring ECGs ($ fee) – Number required: Chemotherapy protocol Vital sign monitoring Spirometry Bronchoscopy Pain assessment Sedation Specify: Sitter required Patient teaching Specify: Other services Specify: Applicant Comments SAMPLE PROCESSING SERVICES Depending on the complexity of your study, and the degree of Laboratory involvement, a Laboratory fee may be assessed. A fee will be assessed for all non-standard of care Laboratory procedures. Sample Processing None requested Blood Specimens Number of samples per patient ____ Number of aliquots:____ Urine Specimens Number of samples per patient ____ Number of aliquots:___ Other - Specify: Sample Storage and Shipping None requested +4°C Storage -20°C Storage -70°C Storage 1 Week Storage 1 Month Storage 3 Month Storage (Maximum) Shipping: Specify destination: All shipping costs paid by investigator Number of samples per patient ____ Number of aliquots:___ Applicant Comments: Page 4 of 6 LABORATORY SERVICES Describe Laboratory Services Required: Storage or Shipping requirements: Laboratory Procedure Standard of Care or Non Standard of Care: Testing of Specimens be done at Baptist Health: (Y or N) *Who is responsible for shipping the samples sent off site? Shipping: Specify destination: All shipping costs paid by investigator # of Inpatients # of Outpatients Name of Test or Procedure Frequency of Test Procedures Duration CPT: CPT: Diagnosis : CPT: CPT: CPT: DRG: RADIOLOGY SERVICES Describe Radiology Services Required: Radiology Procedure Standard of Care or Non Standard of Care: Describe Radiology interpretation services required (Physician): # of Inpatients # of Outpatients Name of Test or Procedure CPT: Diagnosis : CPT: CPT: CPT: CPT: DRG: Page 5 of 6 Frequency of Test Procedures Duration SURGICAL/IMPLANT SERVICES Describe Surgical/Procedural Services Required: Storage or Shipping requirements: Surgical Procedure Standard of Care or Non Standard of Care: PHARMACY SERVICES Describe Medication: Storage Requirements: Monitoring of Storage (temperature specific requirements) How medications supplied (bulk, unit dose, blister packs, etc.) Controlled Substance? (Y/N) Drug approved by FDA (Y/N)? Preparation description: IV product preparation (Describe) PO preparation - liquid reconstitution (Describe) Pharmacy Documentation requirement (Describe) Will Pharmacy be required to meet with a study monitor? (Y/N) If Yes, how often. Inpatient/Outpatient/both LEGAL SERVICES A Letter of Agreement (LOA) must be completed prior to study implementation. Please refer to the attached legal documents. Page 6 of 6