CANCERCENTERPSDMAPPLICATION FORM

Date submitted

Principal investigator

Protocol title (trial name)

Team membership

List the proposed members ofthe research team, and briefly describe their role in the proposed project

Name / Degree / Main duty / Describe participation in this project
selectMD/PhDMDPhDRNMastersBachelornone / PI
selectMD/PhDMDPhDRNMastersBachelornone / Co-investigator
selectMD/PhDMDPhDRNMastersBachelornone / Data manager

Protocol details

Location(s) where trial will be carried out: CFCCC ; Affiliate site ; or both .

List affiliates if applicable:

CTPRMC approval: Pending , or Approval date:

Human subjects: IRB Pending , or Approval #:

UC Irvine protocol number:

Anticipated (or actual)trial start date:

Anticipated (or actual) trial end date:

Patient intervention: Yes , No

Phase of trial: Feasibility , Pilot , Phase I

Type of trial: Therapeutic, Prevention, Diagnostic , Supportive

Investigator initiated: Yes , No

Disease site:

Briefly describe the intervention, device or agent:

Total trial budget:Funding source:

Requested PSDM funding: (details and justification to be providedon page 3 below)

Matching funds requested (include sources):

Priority statement

What was the genesis of the protocol idea (translational working group, program retreat, seminar, etc)?Describe the intellectual input of the PI into the trial design. Note any prior feedback received from cancer center senior leadership.

Innovation and impact

Briefly describe the innovation and overall impact of the proposed protocol (short paragraph)

Project summary

Describe the significance of the problem addressed, goals and objectives, and the approach of the protocol (short paragraph)

Strategic future plans

Describe the goals and objectives for the future of the project, including future funding applications and clinical trials (2-3 sentences).

Budget details and justification

Provide budget details for the overall trial in the table below.

PERSONNEL / ADMIN USE ONLY
NAME / ROLE ON
PROJECT / PERCENT
EFFORT / BASE
SALARY / BENEFIT
RATE / SALARY
REQUESTED / FRINGE
BENEFITS / TOTAL
$0 / $0 / $0
$0 / $0 / $0
$0 / $0 / $0
$0 / $0 / $0
$0 / $0 / $0
SUBTOTALS / $0 / $0 / $0
EQUIPMENT (Itemize)
PATIENT CARE EXPENSES (Itemize by category)
SUPPLIES (Itemize by category)
OTHER EXPENSES (Itemize by category)
TOTAL COSTS FOR BUDGET PERIOD / $ / 0

Describe the need for Data Management funding from the cancer center, including an explanation of why the sponsor is not supporting this aspect of the trial: