Cancer Center Protocol Number

Sue and Ralph Stern Center for Cancer Clinical Trials and Research Disease-Oriented Team (DOT) / Tumor Board (TB) Feasibility Application

All clinical cancer studies, regardless of type or fund source, must undergo a feasibility review by either the corresponding DOT or TB. Submit this completed form and the protocol to: [email protected].

Date Submitted: MM/DD/YY Principal Investigator: Enter text Concept/Study Title: Enter text Reviewing Committee: If an appropriate DOT for the study does not exist, choose the TB. ☐ Genitourinary ☐ Hematologic ☐ Skin ☐ Breast (GU) (Heme) DOTs: ☐ Gastrointestinal ☐ Gynecologic ☐ Neurologic (GI) (Gyn) (Neuro)

TBs: ☐ Head & Neck ☐ Hepatobiliary ☐ Lung

Review the NCI-defined study sources at the bottom of the page and select the appropriate source. Study Source: ☐ National ☐ Externally Peer-Reviewed ☐ Institutional ☐ Industrial

Is this an institutional/investigator-initiated trial (IIT)? ☐ Yes ☐ No If yes, please describe the funding source(s): Enter text

Study Prioritization: ☐ High ☐ Medium ☐ Low Expected UCI accrual total: Whole number only Maximum number of subjects to be consented at UCI (including screen failures): Whole number only Can targeted accrual be met? ☐ Yes ☐ No Provide justification for targeted accrual (e.g. current Cancer Registry Data): Enter text

Projected accrual end date: MM/DD/YY

Does this study compete with existing trials? ☐ Yes ☐ No If yes, list UCI or NCTN ID and provide justification and prioritization: Enter text

List Co-investigators: Enter text Study Sources  National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks  Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism supported by the NIH or an approved peer-reviewed funding organization  Institutional: In-house clinical research studies authored or co-authored by Cancer Center (CC) investigators and undergoing scientific peer-review solely by the Protocol Review and Monitoring System of the CC. The CC investigator has primary responsibility for conceptualizing, designing and implementing the clinical research study and reporting results. It is acceptable for industry and other entities to provide support (e.g., drug, device, other funding) but the trial should clearly be the intellectual product of the center investigator. This category may also include: 1) Institutional studies authored and implemented by investigators at another Center; or 2) Multi-Institutional studies authored and implemented by investigators at your Center  Industrial: The design and implementation of these clinical research studies is controlled by the pharmaceutical company DOT/TB Feasibility Application Version Date: 12/05/2016