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: ____________________________________________________________
_____________________________________________________________________________