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: / DRUG DEVICE
BIOLOGIC CHART REVIEW
OBSERVATIONAL
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 NO IND/IDE No. ______
If Yes, please provide the following IND / IDE information. / Investigator’s Brochure/Product Labeling
Sponsor Reimbursement Package
Are these products FDA approved? / Yes NO
Who will provide the investigational product (drug, device)? / Manufacturer Sponsor
Other (please specify):______

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 Page 1 of 2