Download UMH Clinical Research Services/Resources Requested Form

University of Miami Hospital
UMH CLINICAL RESEARCH SERVICES/RESOURCES REQUESTED FORM
Please fill out both Section One and Two.
SECTION ONE:
STUDY INFORMATION:
Institutional Review Board (IRB)#
Full Title of Study:
PI Name (Last, First):
 Office #:
 Cell/pager #:
Name 24hr Study Physician/PI (Last, First):
 Office #:
 Cell/pager #:
Name of Study Coordinator (Last, First):
 Office #:
 Cell/pager #:
 E-Mail Address:
STUDY DETAILS
Study Type:
_______________________________
_______________________________
_______________________________
_______________________________
_______________________________
_______________________________
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DRUG
BIOLOGIC
OBSERVATIONAL
DEVICE
CHART REVIEW
Name (s) of Drugs or Devices being
investigated (if applicable):
Funding Source:
Industry Sponsored
Non-Industry Sponsored
Sponsor Name:
Does this study involve an IND/IDE ?
Yes
If Yes, please provide the following IND / IDE
information.
Investigator’s Brochure/Product Labeling
Sponsor Reimbursement Package
Are these products FDA approved?
Yes
Who will provide the investigational product
(drug, device)?
Manufacturer
Sponsor
Other (please specify):_______________
Version 01/06/2016
NO
IND/IDE No. ___________
NO
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University of Miami Hospital
SECTION TWO:
Date Requested for Site Initiation Visit:
Protocol Start Date:
Protocol End Date:
UMH CLINICAL SERVICES/RESOURCES REQUIRED
Check services needed for study:
Nutrition Services (i.e. food, education, etc.)
Please specify:__________________________________________
Pharmacy Services (i.e. storage, dispensing, room temperature)
Please specify:__________________________________________
Nursing Services (i.e. vital signs, medication administration, urine collection, etc.)
Please specify:__________________________________________
Radiology (CT Scan, MRI, Ultrasound, etc.)
Please specify:__________________________________________
Cardiology (EKG, ECHO, etc.,)
Please specify:__________________________________________
Pathology/Laboratory (specimens, blood sample, etc.)
Please specify:__________________________________________
Other Services
Please specify:__________________________________________
Patient care areas being utilized for study.
If more than one, please indicate all areas of
service.
Outpatient
Inpatient, regular put on protocol
Expected Length of Stay (LOS):______days
Inpatient, admission for research
Expected Length of Stay (LOS):______days
Comments: __________________________________________________________________________________
____________________________________________________________________________________________
UMH RESEARCH REVIEW COMMITTEE IS NOT an IRB; all protocols must receive IRB approval
before implementation.
If you have any questions regarding UMH CLINICAL RESEARCH SERVICES/RESOURCES
REQUESTED FORM, please contact 305-689-5410.
Version 01/06/2016
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