Scientific Review Committee Protocol Submission Form

Please select:

Initial Submission

Amendment

Protocol ID

PI Name

PI Email Address

Co-PI Name

Protocol ID

Study Contact Name

Study Contact Email

Study Title:

1. Choose the research category

2. Is this a pragmatic study?

Yes

3. Is this a pilot study?

Yes

4. Choose Study Phase

5. Choose Study Source

6. Participating sites (choose all that apply)

UCDH

CCN

Other…

7. Will this be a single or multi-site study?

Single

Multi

If multi-site, is UCD the lead coordinating site?

Yes

8. Does this protocol involve a rare disease as defined by the NCI (annual incidence of <6 per 100,000)?

Yes

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. Does your department have all resources (equipment, staff, etc.) and workflows in place needed to operationalize this protocol?

Yes

If No please elaborate on your plan to meet protocol requirements prior to activation?

19. Have all required departmental feasibility reviews been completed for this protocol?

Yes

If No, please explain

20. Final Protocol Submission

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.

please upload final protocol. If applicable- please upload rare tumor justification

Amendment type, select all that apply

Change to endpoints/objectives

Additional Cohort

Additional IP

Other changes

Does this amendment change the scientific impact of the protocol or new safety information?

Yes

If Yes, describe

Annual accrual goal prior to amendment:

Does this amendment change the annual accrual goal for UC Davis?

Yes

If Yes, new annual accrual goal:

Please upload a track changed and clean version of the amended protocol and summary of changes if available

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.

*By submitting to SRC, all protocols not exempted from the SRC process will also be submitted to DSMC for review.

Do not fill out this field