Baptist Health



Baptist Health/Nemours Research

Administrative Research Approval Committee (ARAC)

Application for Review of Hospital-Based Research

NOTE: Studies conducted at Baptist Health (BH) must receive ARAC approval before presentation to BH Institutional Review Board (IRB).

SITE(S) REQUESTED

Please indicate your preferred site(s) for this work; use numbers to prioritize your preference (if applicable):

| |Baptist-Downtown | | Baptist-South | |Baptist-Beaches |

| |Wolfson Children’s Hospital | |Sacred Heart Pensacola | |Baptist Nassau |

|Protocol Title : |

|Sponsor Name: |Study #: |

|Address: |Phone: |

INVESTIGATIVE TEAM PERSONNEL

|Principal Investigator: |Degree: |

|Title: | Fax : |

|Phone: |Cell Phone: |If not Baptist Health employee: |

|Pager: |Email: |Employer: |

| | | |

| | |Privileges: |

|Address: | |

|Please list all Investigators and Research Assistants who will be participating in this study: |

|Lead Study Coordinator: |Degree: |

|Title: |Fax : |

|Phone: |Cell Phone: |If not Baptist Health employee: |

|Pager: |Email: |Employer: |

| | | |

| | |Privileges: |

|Address: | |

LEGAL SERVICES

A Letter of Agreement (LOA) must be completed prior to study implementation.

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.

PATIENT CARE AREA(S) REQUESTED

Please indicate your preferred site(s) for this work; use numbers to prioritize your preference (if applicable):

|Adult Units | |Pediatric Units |

| |Heart Hospital | | |Emergency Department |

| |Emergency Department | | |Med/Surg |

| |Med/Surg | | |Oncology |

| |ICU | | |NICU |

| |Radiology/Nuclear Medicine | | |PICU |

| |Cath Lab/EKG/Respiratory | | |Children’s Research Center |

| |Operating Room | | |Operating Room |

| |Pharmacy | | |Pharmacy |

| |Laboratory | | |Laboratory |

| |Oncology | | |Other: |

| |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.

PROJECTION UTILIZATION

|Projected Enrollment: |Start Date: |End Date: |

|Specify Participant Diagnosis(es) and/or Inclusion Criteria: |

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Specialty Rooms Required For the Study

| |Negative pressure isolation | |Special Storage |

| |Monitored sleep room | |Other: |

| |Lead-lined room | | |

|Applicant Comments: |

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PARTICIPANT AGE RANGE

check all that apply

| |Birth - 1 month | |>1 month - 2 years | |>2 - 10 years |

| |>10 - 17 years | |>18 - 64 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.)

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List investigator/sponsor-owned equipment being used for this study and whom the equipment will be provided by and where will it be stored.

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Note: All equipment that is not the property of Baptist Health must be cleared by Biomed prior to being utilized for research.

SURGICAL/IMPLANT SERVICES

|Describe Surgical/Procedural Services Required: |Storage or Shipping requirements: |Surgical Procedure Standard of Care or Non Standard |

| | |of Care: |

| | | |

| | | |

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 |InPt |OutPt |Procedures Requested |

| | |IV Lines: # ____ | | |Urinary catheterization |

| | |Central line blood draws, # ____ | | |Central line care |

| | |Blood draws per participant ___ | | |Aerosolized treatments |

| | |Medication administration | | |Blood glucose monitoring |

| | |Questionnaires – #_____: | | |ECGs ($ fee) – Number required: |

| | |Other specimen collection (stool, urine, etc.) | | |Chemotherapy protocol |

| | |____________ Number per subject: ______ | | |Vital sign monitoring |

| | |____________ Number per subject: ______ | | |Spirometry |

| | |____________ Number per subject: ______ | | |Bronchoscopy |

| | |Administer blood, blood products | | |Pain assessment |

| | |Pre- / Post-operative care | | |Sedation Specify: |

| | |Enteral tube placement | | | |

| | |Continuous/intermittent IV drug infusion: | | |Sitter required |

| | |Length of infusion:______ | | | |

| | |Seizure/sleep monitoring | | |Patient teaching Specify: |

| | |Pulse oximetry monitoring | | |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 |Sample Storage and Shipping |

| |None requested | |None requested |

|Blood Specimens | |+4°C Storage |

| |Number of samples per patient ____ | |-20°C Storage |

| |Number of aliquots:____ | |-70°C Storage |

|Urine Specimens | |1 Week Storage |

| |Number of samples per patient ____ | |1 Month Storage |

| |Number of aliquots:___ | |3 Month Storage (Maximum) |

|Other - Specify: | |Shipping: |

| | |Specify destination: |

| | | |

| | | |

| | | |

| | |All shipping costs paid by investigator |

| |Number of samples per patient ____ | | |

| |Number of aliquots:___ | | |

|Applicant Comments: |

| |

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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 |*Who is responsible for shipping the samples sent |Shipping: |

|or N) |off site? |Specify destination: |

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| | |All shipping costs paid by investigator |

|# of Inpatients |# of Outpatients |Name of Test or Procedure |Frequency of Test Procedures |Duration |

| | |CPT: | | |

|Diagnosis : |CPT: | | |

| |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): | |

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|# of Inpatients |# of Outpatients |Name of Test or Procedure |Frequency of Test Procedures |Duration |

| | |CPT: | | |

|Diagnosis : |CPT: | | |

| |CPT: | | |

| |CPT: | | |

| |CPT: | | |

| |DRG: | | |

Investigational Pharmacy Services

|Investigational Product Description: |Storage Location: |Temperature monitoring requirements: |

|Name:_____________________ |AIDHC: 3C-168 (Attn: Lisa M. Brown) |Temperature monitoring plan for |

|Strength:___________________ |NCH: 3rd Floor Inpatient Pharmacy (Attn: Julie Duke) |ambient/refrigerator/freezer (includes notification |

|Therapeutic Class:____________ |Jacksonville: Nemours Clinic (Attn: Marjorie Delucia) |system for variances) with back-up monitoring. |

|Formulation: |Jacksonville: Baptist Heath/ Wolfson Children’s Hospital |Specify temperature range: |

|Oral |(Attn: Marjorie Delucia) |Ambient ____________ Celsius |

|Tablet/ Capsule |Pensacola: Nemours Clinic (Attn: Holly Turner or Dannah | |

|Liquid/Suspension |McCormick) |Refrigerator ____________ Celsius |

|Other:____________ |Pensacola: Sacred Heart Hospital (Attn: Tara Smith or Chenita| |

|Intravenous |Carter) |Freezer ____________ Celsius |

|Intramuscular |Storage Requirements: | |

|Subcutaneous |Access limited to pharmacy study personnel. Investigational | |

|Intradermal |Product must be delivered directly to pharmacy personnel. | |

| |Locked storage | |

| |Investigational research pharmaceutical products stored | |

| |separately from clinic supplies. | |

|Drug Category: |Dispensing: |Drug Supply requirements: |

|Chemotherapy/Antineoplastic |Inpatient |Only order when subject enrolled |

|Gene therapy/biologics |Outpatient |Maintain active inventory |

|Immunotherapy |Both |Drug Supplied By: |

|Other |Requires Order-set Build |NCI |

| | |Sponsor |

|Compounding Required | |Institution Formulary |

|Yes | | |

|No | | |

|Number of anticipated enrollments: |Drug approved by FDA: |Drug Handling: |

| |Yes |Hazardous |

| |No |Non-hazardous |

| |IND number:_____________ (if applicable) | |

|Controlled Substance: |Training: |Pharmacy Documentation Requirements: |

|Yes |IVRS Pharmacy Access Needed |NCI Agent Accountability Form (DARF) |

|No |Additional training required |Sponsor Supplied Accountability Forms |

| | |Other:______________________ |

|Describe randomization and blinding procedure if|Charging requirements (if any): |Pharmacy Reimbursement by Sponsor |

|applicable: |Charging for investigational articles may only occur under |Yes |

| |very limited circumstances and must be compliant with FDA |No |

| |regulations. |Sponsor will conduct monitoring visits |

| | |Yes |

| | |No |

|Are additional supplies required: |Will additional supportive medications be supplied by the |Final disposition of used, unused and expired |

|Additional medications (including supportive |study/ sponsor: |investigational product: |

|medications) |Yes |On-site disposal |

|Other |No |Return to sponsor |

|Yes___________________ | | |

|No | | |

|Study Information Provided to Pharmacy: |

|Protocol |

|Investigator’s Brochure |

|Pharmacy Manual of Procedures |

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