Download EXPEDITED ADMINISTRATIVE CHECKLIST

Principal Investigator___________________________
IRB Protocol #________________________________
FULL COMMITTEE ADMINISTRATIVE CHECKLIST
*If applicable*
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Financial Review Form
Attach Budget/Contract
Submit directly to Mary Walsh
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General Application
1 Original and 10 copies
With Required Original Signatures
Consent Form(s) and
1 Original and 10 copies
HIPAA Authorization
Conflict of interest disclosure form
1 Original and 10
For ALL key personnel
copies
The Principal Investigator’s
1 Copy
Current CV
FDA’s 1572 Form
1 Original and 10
(for investigational drugs)
Copies
Fully Detailed Protocol
1 Original and 10 copies
(Original should be
single-sided, copies can
be double-sided)
*Investigator Brochure
1 Original and 3 copies
*Retrospective Chart Review Form/Confidentiality
CITI Course (Mandatory for ALL key personnel)
*Appropriate Addenda
1 original and 10 copies
*PRMC Approval
1 original and 10 copies
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Use of Biohazards/Gene
Therapy
Drug/Device
Biohazard-gene transfer
addendum.doc
Drug device addendum.doc
Drug Storage Waiver
Drug storage waiver.doc
Human Specimen/Genetic
Research
Radioisotopes/Ionizing
Radiation
Human specimen
addendum.doc
Ionizing radiation
addendum.doc
Use of Placebo
Placebo addendum.doc
Waiver of informed consent
Waiver of informed
consent.doc
Version date 7/24/08
1 Original and 1 copy
Complete if study involves the use
of potentially infectious materials
Complete if study involves the use
of drugs and/or devices
Complete if drug will not be stored
in the pharmacy
Complete if specimen/genetic
research will be conducted
Complete if radioisotopes or other
ionizing radiation will be used
during the course of the study
Complete if placebo will be used
during the course of the study
Complete if informed consent (or
parental informed consent) will not
be obtained
Principal Investigator___________________________
IRB Protocol #________________________________
**PLEASE COLLATE ALL SUBMISSIONS**
Version date 7/24/08