NAME OF APPLICANT

 

PROJECT TITLE

 

 

FUNDING SOURCE

□ Federal agency: _____________________________________________________________

□ Industry-sponsored: _________________________________________________________

□ Private source:  _____________________________________________________________

□ Other:  _____________________________________________________________________

IRB/IACUC APPROVAL:       Yes □   Study #: _________________     No □

SITE APPROVALS:   NR3 form(s) sent?  Yes □   No □       

INDICATE HOSPITAL SITES:  Aston □   Zale □   St. Paul □   Parkland □    CMC □

STUDY AIMS

 

 

 

 

 

 

 

NUMBER OF SUBJECTS:

BRIEF DESCRIPTION OF METHODOLOGY

 

 

 

 

 

SUBJECT RISK (Check all that apply and describe in methodology section)

□ Observational study             □ Laboratory tests

□ Interventional study             □ Study will change subject’s care

□ Radiologic studies               □ Collects sensitive information (HIV status, pregnancy)

□ Genetics study                     □ Other: ___________________________________________

PROJECTED BUDGET

Year 1: _______________________________________________________________________

Year 2: ­­­­­­­­­­­­­­­­­­­­­_______________________________________________________________________

DEPARTMENT AND OTHER RESOURCES (Check all that apply)

□ Statistical support including power analysis

□ Assistance completing IRB application

□ Clinical research training not completed

□  Assistance collecting or mailing samples

□ Audiology

□ Speech-language pathology

□ Physical therapy

□ Radiology

□ Pathology

□ IR Call Center to identify patients by CPT and/or ICD-9 codes

□ Aston medical records--specify who will request charts and review them:

    ___________________________________________________________________________

□ Use of media room computer

□ Use of a department database

□ Use of investigational drugs or devices

□ Use of investigational procedures

□ Other (including medical records requests from other hospitals):

_____________________________________________________________________­­­­________

DEPARTMENTAL USE

Review Date: _________________________________________________________________

□ Protocol approved

□ Clarifications requested: _____________________________________________________

_____________________________________________________________________________

□Protocol not approved

□ Other comments: ____________________________________________________________

 

_____________________________________________________________________________