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Scientific Review Committee Protocol Submission Form
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PI Name
PI Email Address
Co-PI Name
Protocol ID
Study Contact Name
Study Contact Email
Study Title:
1. Choose the research category
- Select -
Ancillary/Correlative
Interventional
Observational
2. Is this a pragmatic study?
Yes
No
3. Is this a pilot study?
Yes
No
4. Choose Study Phase
- Select -
I
I/II
II
II/III
III
N/A
5. Choose Study Source
- Select -
Industry
Institutional
National
Externally Peer Review
6. Participating sites (choose all that apply)
UCDH
CCN
VA
Other…
Enter other…
7. Will this be a single or multi-site study?
Single
Multi
If multi-site, is UCD the lead coordinating site?
Yes
No
8. Does this protocol involve a rare disease as defined by the NCI (annual incidence of <6 per 100,000)?
Yes
No
If yes, please attach rare tumor documentation with submission
One file only.
100 MB limit.
Allowed types: txt, rtf, pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods.
9. If this is an Institutional (IIT) study, please provide the name of the Statistician.
10. Annual UCD Expected Accrual (if, < 3 please justify)
11. Studywide Expected Accrual
12. Current Enrollment (please add # of patients enrolled to date studywide).
13. Anticipated accrual period in months
14. List competing studies
15. List the coordinating management team (i.e. OCR, CCN, ASSC, etc.)
16. Does your study exclude women, minorities, children or older adults? If so, please justify.
17. Does your study have the capacity to enroll non-english speaking participants (e.g. consent and other patient-facing materials)? If not, please justify.
18. Final Protocol Submission
please upload final protocol. If applicable- please upload rare tumor justification
Unlimited number of files can be uploaded to this field.
100 MB limit.
Allowed types: txt, rtf, pdf, doc, docx, odt, ppt, pptx, odp, xls, xlsx, ods.
Do not fill out this field
