Download Baptist Health Administrative Research Approval Committee (ARAC

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:
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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.
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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.
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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:
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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 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:
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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.
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