Today's Date
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Today M-D-Y
Principal Investigator
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Principal Investigator Email
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Principal Investigator Department
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Is the Principal Investigator the primary contact for this study?
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Yes
No
Primary Study Contact Name
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Primary Study Contact phone number
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Primary Study Contact email
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Study Emergency Contact Name
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Study Emergency Contact Phone Number
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Investigator attestation: In signing this form, I confirm that all information contained herein is true and correct to the best of my knowledge.
In the next box type your name:
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Study Title
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Department-Funded
Industry
Federal Grant (e.g., NIH, DOD, etc.)
Other Grant (e.g., Shriners, American Heart Association, etc.)
Upload Study Protocol
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IRB Number (core number, no dashes)
If not yet submitted to IRB please enter 11111
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Has this study been acknowledged or approved by the UC Davis IRB?
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Yes
No
Upload IRB Approval letter (if applicable)
Is the UC Davis IRB relying on another IRB for this study?
Yes
No
Name of IRB of record (i.e., the IRB that UC Davis is relying on)
Is this study approved by the IRB of record?
Yes
No
Upload IRB Approval letter (if applicable)
I attest that the IRB Approval letter will be submitted to the Pathology and Laboratory Medicine Clinical Research Oversight Committee (CROC) once it becomes available.
Yes
I attest that the IRB Approval letter will be submitted to the Pathology and Laboratory Medicine Clinical Research Oversight Committee (CROC) once it becomes available.
Yes
Anticipated Study Start Date (MM-DD-YYYY)
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Today M-D-Y
What is the anticipated maximum number of subjects to be enrolled at UC Davis?
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Approximately how long will it take to recruit all subjects to be enrolled at UC Davis?
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How long is each subject enrolled in the study?
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Please complete the following sections for all requested pathology and laboratory medicine resources. Discrepancies between requested resources and those included in the study protocol may lead to delays in the review process.
If you have questions, please refer to our FAQ or email hs-pathresearch@ucdavis.edu. Phlebotomy
If phlebotomy is being performed by a patient's bedside nurse or other staff NOT employed by the Department of Pathology and Laboratory Medicine (DOPLM), please mark NO.
Please note, DOPLM is responsible for phlebotomy services at the Laboratory Patient Service Centers listed HERE . * must provide value
Yes
No
List Visits per Protocol where this resource is needed (Example: Visit 1 - Screening; Visit 2 - Day 30 (+/- 1) )
Lab Draw Site(s)
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Please specify "Other" locations
Clinical Laboratory Testing (e.g., chemistry, hematology, molecular diagnostics, microbiology, toxicology, etc.)
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Yes
No
Is this a Cancer Center Clinical Trial?
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Yes
No
Does this study meet the Quick Review Criteria?
(All requested tests are on the approved list)
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Yes
No
This test will be billed to:
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Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
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Name of Test Requested (2)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (3)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (4)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (5)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Additional tests requested?
Yes
No
Name of Test Requested (6)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (7)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (8)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (9)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (10)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Additional tests requested?
Yes
No
Name of Test Requested (11)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (12)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (13)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (14)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (15)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (16)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (17)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (18)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (19)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Name of Test Requested (20)
Leave blank if not needed
This test will be billed to:
* must provide value
Patient/Patient's Insurance
Research
List visits per protocol where this test is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
* must provide value
Anatomic Pathology (e.g., tissue histology, cytopathology, etc.)
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Yes
No
List visits per protocol where this resource is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
Describe Anatomic Pathology resources needed
Transfusion Medicine (e.g., blood bank and apheresis)
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Yes
No
List visits per protocol where this resource is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
Describe Transfusion Medicine Resources needed
MNC Collection
HPC Collection
Therapeutic Plasma Exchange
Red Blood Cell Exchange
Extracorporeal Photopheresis
Other (please specify in description box)
Describe Apheresis resources needed
Upload any additional laboratory or operations manuals to be reviewed by our Apheresis Staff
Will Apheresis staff be trained and added to the Delegation Log for this study?
Yes
No
Describe Blood Bank resources needed
Please specify "Other" Transfusion Medicine resources needed
Point-of-Care Testing
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Yes
No
List visits per protocol where this resource is needed (Examples: Screening, Visit 2 - Day 30 (+/- 1), End of Study ).
For ease of review, please use visit names consistent with the protocol.
Describe Point-of-Care Testing resources needed
HRP-503
If you submitted a sponsor protocol and an HRP-503 to the IRB, please include your HRP-503 here.
Material Transfer Agreement (MTA)
Please upload any other forms required for CROC review
Please include any additional information you would like to communicate in this submission.
Leave blank if not needed