Gelb Center Project Summary Sheet

DF/HCC Tissue and Clinical Revised: 03/03/2016 Project Proposal Annual Renewal Form DF/HCC BOC USERS COMMITTEE PROJECT ANNUAL RENEWAL FORM

Please Note:  This renewal form is to be used for all projects previously approved by the DF/HCC Breast Users Committee. The Users Committee, consisting of medical oncologists, radiation oncologists, surgeons, pathologists, laboratory scientists, and a biostatistician will review all projects on an annual basis to evaluate scientific merit and feasibility and to determine whether sufficient resources exist within the center to support such a project.  Please fill out the following form as completely as possible in order to give the committee a full understanding of the progress that has been made and how the DF/HCC resources have been used in your If this project is protocol based, whether research or clinical, please include a copy of the protocol with this form, and any related IRB correspondence, such as the approved continuing review form.  If you have any questions regarding this form or the renewal process please contact the DF/HCC Breast Tissue administrator, Lauren Knelson, 617-632-1904, [email protected]

Thank You, The DF/HCC Breast Users Committee

DF/HCC BREAST PROJECT INFORMATION: Proposal Title: Principal Investigator: Site Responsible Investigator(s): If the PI is a member of the Dana-Farber Cancer Institute, please list all Co-Investigators: PI Institution: ______

CONTACT PERSON INFORMATION: Name: Address/Room Number: Telephone/Pager: E-Mail: ______FOR OFFICE USE ONLY: Date of Request: Date of Approval: Version #:

1 DF/HCC Tissue and Clinical Revised: 03/03/2016 Project Proposal Annual Renewal Form

DF/HCC BREAST USERS COMMITTEE REQUEST PROCESS

REQUESTING INVESTIGATOR Obtain Proposal Form and Submit

CO-CHAIRS NANCY LIN, MD DEBORAH DILLON, MD LAURA COLLINS, MD

USERS COMMITTEE MEMBERS

WILLIAM BARRY, PHD JENNIFER BELLON, MD MYLES BROWN, MD LEIF ELLISEN, MD PHD JUDY GARBER, MD, MPH MEHRA GOLSHAN, MD MICHAEL HASSETT, MD, MPH STEVEN ISAKOFF, MD, PHD TARI KING, MD IAN KROP, MD, PHD BEVERLY MOY, MD ANN PARTRIDGE, MD, MPH STUART SCHNITT, MD BARBARA SMITH, MD NADINE TUNG, MD ERIC WINER, MD JULIA WONG, MD JEAN ZHAO, PHD

As a reminder, if the samples need to be sent out of DFCI to another institution a Material Transfer Agreement (MTA) needs to be signed and approved by Office of General Counsel before clinical data and/or specimens are released. Researchers can request de-identified tissue or blood samples and linked clinical data collected under 11-104 or our previous protocol, 93-085, without obtaining additional IRB approval for the specific research question. Users must sign a data use agreement stating that the bank will not provide, and the Users will not attempt to learn, the identity of the patients. If an identified data set or a limited data set (e.g. a data set that

2 DF/HCC Tissue and Clinical Revised: 03/03/2016 Project Proposal Annual Renewal Form contains dates of treatment) is requested, then IRB approval specific to the project (e.g. beyond that provided in 11-104 or 93-085) must be obtained by the requesting researcher before release of clinical data or specimens.

IMPORTANT: All modifications to the original request must be resubmitted to the appropriate committee before additional resources can be dispensed.

FEE STRUCTURE: There may be fees associated with requests for clinical data, tissue/blood specimens and pathology services. Details will be sent upon approval of proposals. For outside tissue block requests, there are additional fees (including requests for BWH).

1. Summary of Proposed Project (Including Project Goal(s)): Please provide a 1-2 paragraph summary of the proposed project.

2. Progress Report: Please provide a 1-2 paragraph update on your progress in the last year

3. Publications: Please list any publications generated by this project

4. Use of Clinical Data: Please describe the data elements collected as part of this project.

5. Use of Specimens: a. Please describe the use of specimens in your project, if applicable. For each marked item, approximately how many samples were used/collected?

Specimen Type Quantity Volume (specify #s of (µl)/subject blocks or cases, tumor and/or normal) OCT-Embedded Tissue Paraffin-Embedded Tissue H&E Stained Slides Serum Plasma Whole Blood DNA/RNA PDX Models

6. Timeframe to Completion, if applicable:

Please give an estimated timeframe for completing this project.