Cancer Center Protocol Number

Cancer Center Protocol Number

<p> Sue and Ralph Stern Center for Cancer Clinical Trials and Research Disease-Oriented Team (DOT) / Tumor Board (TB) Feasibility Application</p><p>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].</p><p>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)</p><p>TBs: ☐ Head & Neck ☐ Hepatobiliary ☐ Lung</p><p>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</p><p>Is this an institutional/investigator-initiated trial (IIT)? ☐ Yes ☐ No If yes, please describe the funding source(s): Enter text</p><p>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</p><p>Projected accrual end date: MM/DD/YY</p><p>Does this study compete with existing trials? ☐ Yes ☐ No If yes, list UCI or NCTN ID and provide justification and prioritization: Enter text</p><p>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</p>

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    1 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us